Clinical Digest: Recent Clinical Trials on Avian Influenza
To assist researchers and healthcare practitioners in staying up-to-date with the latest advancements in clinical research, the Clinical Digest Team has compiled a comprehensive list of recent clinical trials related to Avian Influenza. These trials are organized by their release dates for your convenience. (Last updated on: 2025-05-02)
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TABLE 1: Clinical Digest: Recent Clinical Trials on Avian Influenza
| Clinical Trial | Contact(s) | Date | |
|---|---|---|---|
| 1 | Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine whether drinking pasteurized milk (milk heated to kill harmful germs) that contains inactive particles of a flu virus called A(H5) could lead to the detection of the virus in the nose or throat. Inactive particles are not capable of causing disease. The results will help the Centers for Disease Control and Prevention (CDC) better understand how milk consumption could affect flu surveillance. Investigators also want to see if the body produces antibodies in response to this milk consumption. |
DANIEL S. GRACIAA; | 2025-05-01 |
| 2 | Dose-Escalation Study of A Low Pathogenicity Avian H10N7 Influenza Virus in A Healthy Human Challenge Model PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Influenza, also called flu, is a virus. It can cause mild symptoms such as fever, cough, sore throat, and aches. Sometimes, flu can cause serious complications. Researchers want to see how people s immune systems respond to the flu. Objective: To find the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people. This dose will be used in the future to test how well new flu vaccines work. Eligibility: Healthy adults age 18-50. Design: Participants will be screened with: Physical exam with vital signs and weight Medical and medicine review Blood and urine tests Electrocardiogram to measure the heart s electrical activity. Screening tests will be repeated during the study. Participants will be tested for SARS-CoV-2 and other respiratory infections. For this, a swab will be inserted into the back of the nose. Participants will be admitted to an isolation room in the Clinical Center. They will stay in the hospital for at least 10 days. They will not have visitors. Participants may have a heart ultrasound. They may have lung function tests. For this, they will blow into a tube to measure lung capacity. One dose of the flu virus will be sprayed into participants nostrils. Participants will be monitored 24 hours a day. They will give nasal samples (using nasal washes and brushes) and blood samples almost every day. They will complete surveys about their symptoms. Participants will be discharged after they have 2 consecutive negative tests for flu. Participants will have at least 4 follow-up visits: 1 visit every 2 weeks for 8 weeks. |
MATTHEW J MEMOLI; | 2023-10-23 |
| 3 | Clinical Efficacy of Xylitol Based Nasal Spray for The Treatment of Mild COVID-19 Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Xlear have developed and patented a xylitol containing nasal spray for the treatment of upper-respiratory tract infections. The nasal spray is comprised of xylitol and GSE (Grapefruit Seed extract) which provides antibacterial properties as well as preventing viral adhesion in the nasal passage. Studies into Xlear’s antiviral effects on SARS-CoV-2 are currently ongoing but hypothetically, a Xylitol Based Nasal spray may prove to be a useful and inexpensive treatment for COVID-19 infection. |
AHSAN W RATHORE; | 2022-11-28 |
| 4 | Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID: Study Protocol for A Pragmatic Randomized Controlled SuperiorityTrial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Fatigue is among the most common symptoms of the long-term effects of coronavirus (long COVID). This study aims to compare the effectiveness of osteopathic manipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PT alone on fatigue and functional limitations after two months post randomization in adults with long COVID. Methods: This is a study protocol for a two-arm, assessor-blinded, pragmatic randomized controlled superiority trial. Seventy-six participants will be randomly allocated to OMT+PT or PT. The PT includes usual care interventions including motor and respiratory exercises targeting cardiorespiratory and skeletal muscle functions. The OMT entails direct, indirect, visceral, … |
ANA CHRISTINA CE CURI; | 2021-09-20 |
| 5 | Evaluation of Effects, Safety, Viral Load and Antibody Level of Functional Food Dietary Supplement Containing Grape Products in Controlled, Randomized Study Using SARSCoV-2 RT-PCR Positive Covid-19 Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to determine the safety and efficacy profile of the food supplement (KUNAMIN®) containing grape juice, seed, stem, and bark given to patients treated with the established treatment regimen against novel coronavirus infectious disease (COVID-19) via comparing Kunamin® group versus control group in a clinical trial. In this study, both the therapeutic effect and the safety of the Kunamin® product has been evaluated. The study has been conducted on COVID-19 infected patients. Within the scope of the study, … |
RAAS NUTRITIONALS | 2021-05-29 |
| 6 | Efficacy of Convalescent Plasma for The Treatment of Severe SARS-CoV-2 Infection: A Randomized, Open Label Clinical Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Convalescent plasma has been used for over 100 years in the treatment of severe acute respiratory infections of viral origin. There are not pharmacological treatments for the actual outbreak for SARS-Cov-2 and it is necessary to evaluate the efficacy of treatment options, including convalescent plasma transfusion. The hypothesis is that convalescent plasma is efficacious and safe for reducing mortality in patients with COVID-19 treated in ICU |
OLIVER PERILLA SUAREZ; | 2020-06-01 |
| 7 | Efficacy and Safety of Recovered Covid 19 Plasma Transfusion to Covid 19 Severly Ill Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The discovery of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the outbreak of coronavirus disease 2019 (COVID-19) are causing public health emergencies. A handful pieces of literature have summarized its clinical and radiologic features, whereas therapies for COVID-19 are rather limited. To evaluate the efficacy of convalescent plasma therapy in COVID-19 patients. |
OSSAMA HAMDY SALMAN; | 2020-05-29 |
| 8 | Experimental Use of Convalescent Plasma for Passive Immunization in Current COVID-19 Pandemic in Pakistan in 2020 PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Experimental Use of Convalescent Plasma of Passive Immunisation In Current COVID-19 Pandemic in Pakistan in 2020 Rationale & Objective: This study would help to gather real-life setting clinical data in local population, ultimately leading to increased evidence based management of the disease condition in the said population. Eligibility: 1. informed consent must have been obtained 2. confirmed COVID-19 cases confirmed by RT-PCR laboratory tests 3. moderately severe or severe life-threatening COVID-19 related features: a) Moderately Severe disease as defined by the following features: i) Shortness of breath, ii) respiratory rate ≥ 30/min, iii) arterial blood oxygen saturation ≤ 92%, … |
TAHIR SHAMSI; | 2020-05-01 |
| 9 | Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic. Objectives: To assess the efficacy of Ivermectin in mild cases of COVID-19 patients on the basis of predefined assessment criteria. Study Settings: Fatima Memorial Hospital, Lahore Study Design: Open label randomized control trial. Duration of Study: From 1st May, 2020 to 30th June, 2020.Patients & Methods: Sample size and technique: Sample size was 50 patients; … |
AIJAZ ZEESHAN KHAN CHACHAR; | 2020-05-01 |
| 10 | Retrospective Study From November 2019 -Febrauary 2020 on Severe Respiratory Illness to Access The Presence or Absence of COVID-19 in Patients Samples By Real-time PcR PF:4 Related Papers Related Patents Related Grants Related Experts View Abstract: A- Methodology adopted in the retrospective study: Sample Size Determination: 500 case presented from November 2019- February 2020 will be included in explore study from Ain shams … |
SARA HASSAN AGWA; | 2020-04-14 |
| 11 | Determination of The Effectiveness of Oral Chlorine Dioxide in The Treatment of COVID 19 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Abstract The objective of this study is to review, through prospective case research, the efficacy of oral chlorine dioxide in the treatment of patients with COVID infection 19. The research will be carried out between April and June 2020 with a quasi-experimental design in two health care centers on a sample of twenty (20) patients, through direct intervention, who will measure the changes in the manifest symptoms of infection and negativity. a COVID 19 after administration of the study preparation, … |
EDUARDO INSIGNARES CARRIONE; | 2020-04-01 |
| 12 | Evaluation of Novel Molecular Assays for The Detection of Influenza Virus Related Papers Related Patents Related Grants Related Experts View Highlight: Seasonal influenza virus causes an estimated 0.3-0.6 million deaths per year. Avian influenza virus H5N1, H7N9 and H5N6 has fatality rate of over 30%. Swine influenza viruses from pigs have also infected humans. Molecular assays are now used routinely in the detection of influenza viruses. The M gene is often used as the target for all influenza A viruses because the nucleotide sequence of this gene is relatively conserved among all the influenza A viruses. The World Health Organization and the US Centers for Disease Control and Prevention (CDC) have published protocols for molecular detection of influenza A virus M gene. However, recent studies have shown that mutations in the M gene have led to a reduced sensitivity of RT-PCR assay targeting this gene. Therefore, it is important to use alternative conserved genes as the target of RT-PCR. In this study, our aim is to evaluate two new RT-PCR assays that are based on PB2 and NS gene segment. |
KELVIN KAI-WANG TO; | 2019-04-18 |
| 13 | Human Immune Responses to An Adjuvanted H5 Vaccine: Durability and Impact of The Seasonal Influenza Vaccine on H5 Induced B Cell Response PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The study is a prospective single site exploratory study to examine the impact of Food and Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1 vaccine previously received with or without the AS03 adjuvant. |
NADINE ROUPHAEL; | 2018-10-11 |
| 14 | A Phase I Randomized, Double-blind, Placebo-controlled, Dose Finding Clinical Trial to Evaluate The Safety and Immunogencity of H7N9 Influenza Antigen Adjuvanted With 2 Different Adjuvant Formulations in Healthy Adult Volunteers in Brazil PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants . |
ESPER KALLAS; | 2018-09-24 |
| 15 | A Phase 1, Randomized, Controlled, Observer-blind Study to Assess The Reactogenicity, Safety, and Immunogenicity of A Live Attenuated Universal Influenza Vaccine (cH8/1N1 LAIV) Administered As A Single Priming Dose Followed Three Months Later By A Single Booster Dose of An Inactivated Universal Influenza Vaccine (cH5/1N1 IIV) (Adjuvanted With AS03A or Unadjuvanted) in 18 Through 39 Year-old Healthy Subjects, Contrasted With A Two Dose Schedule of An Inactivated Universal Influenza Vaccine (cH8/1N1 IIV + AS03A Followed Three Months Later By CH5/1N1 IIV + AS03A) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant. |
DAVID BERNSTEIN; | 2017-10-10 |
| 16 | A Phase 2/3 Double Blinded, Randomized, Placebo-controlled Study in Healthy Adult Volunteers in Vietnam to Examine The Safety and Immunogenicity of An Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced By IVAC PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested. |
TRAN N DUONG; | 2017-03-07 |
| 17 | A Randomised, Controlled, Blinded Phase 1 Study to Evaluate The Immunogenicity and Safety of A Pandemic Avian H5 Influenza Vaccine in Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant formulations administered by intramuscular injection |
DIMITAR SAJKOV; | 2015-07-01 |
| 18 | Phase 1/2 Adaptive Design Trial to Evaluate The Immunogenicity and Safety of Panblok (H7 RHA) at Three Dose Levels Adjuvanted With A Stable Oil-in-Water Emulsion Compared With Unadjuvanted H7 RHA in Healthy Adults Aged 18 and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation. |
JOHN J TREANOR; | 2015-07-01 |
| 19 | The Threat of Infectious Encephalitis in Southeast Asia: SouthEast Asia Encephalitis Project PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Encephalitis, an acute inflammation of the central nervous system associated with neurologic dysfunction is of public health concern worldwide, because of its high mortality and neurological sequelae rates. In Asia where many of the possible etiologies are of major public health concerns (i.e. dengue, Japanese encephalitis, West Nile virus, EV71), acute encephalitis is among the most frequent and severe causes of pediatric hospitalization. Despite extensive microbiological investigations, … |
MARC LECUIT; | 2014-07-15 |
| 20 | Evaluation of Priming Effects By Pandemic Live Attenuated Influenza Vaccine (LAIV Candidate Vaccine Strain A/17/Turkey/Turkey/05/133 (H5N2)) on The Subsequent Response to Inactivated H5N1 Vaccine in Healthy Thai Volunteers: A Non-Randomized, Open Label Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aim to compare immunogenicity of the inactivated H5 influenza vaccine single dose between subjects previously vaccinated with LAIV H5N2 and naïve subjects |
PUNNEE PITISUTTITHUM; | 2014-06-01 |
| 21 | Phase 1 Evaluation of The Optimal Interval Between Priming With A Live Influenza A Vaccine H7N9 (6-2) AA Ca Recombinant (A/Anhui/1/2013 (H7N9) X A/Ann Arbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease Followed By Boost With A Non-adjuvanted Inactivated H7N9 Influenza Vaccine PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals. |
KAWSAR TALAAT; | 2014-05-01 |
| 22 | A Phase I/II Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate The Immunogenicity and Safety of Monovalent A/Anhui/1/13 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Matrix-M1™ PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years. Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, … |
NOVAVAX | 2014-03-01 |
| 23 | A Single-centered, Open-labeled, Phase 4 Study of A Northern Hemisphere 2013-2014 Seasonal Trivalent Influenza Inactivated Vaccine, Anflu® PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years. |
YONG-GANG SHEN; | 2013-12-01 |
| 24 | Reactogenicity, Safety and Immunogenicity of A Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart. |
OLEG I KISELEV; | 2013-10-01 |
| 25 | Phase 1 Evaluation of The Safety and Immunogenicity of Live Influenza A Vaccine H7N9 (6-2) AA Ca Recombinant (A/Anhui/1/2013 (H7N9) X A/Ann Arbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease in The Event of A Pandemic PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: H7N9 avian influenza (AI) viruses have caused a recent outbreak of severe respiratory disease in humans in China. The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults. A single dose of inactivated subvirion H7N9 influenza vaccine will be administered 3 months later. |
JOHN TREANOR; | 2013-10-01 |
| 26 | A Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually emerge and require new investigations to understand pathogen biology and pathogenesis in the host. Witness the Influenza A pandemic. Concerns about new viruses and their impact on health and the economy are also increasing. Current alerts sent out by the Ministry of Health (about the novel coronavirus and the Avian influenza A virus) are but cases in point. These likely reflect advances in science, … |
TAN BAN HOCK; | 2013-08-01 |
| 27 | A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate The Immunogenicity and Safety of Monovalent A/Anhui/1/2013 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Adjuvant 1 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups. Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, … |
NOVAVAX | 2013-07-01 |
| 28 | Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without AS03 Adjuvant (HIPC: VAX-010) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 bird flu virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu. |
NADINE ROUPHAEL; | 2013-07-01 |
| 29 | Phase I Study of The Safety and Immunogenicity of A Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the safety and immunogenicity of VAX161B [STF2.HA5 H5N1], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses. |
ERIC SHELDON; | 2012-06-01 |
| 30 | Open-Label, Dose-Escalation, Phase I Study of The Prime-Boost Investigational 2012/13 Seasonal Influenza DNA Vaccine, VRC-FLUDNA063-00-VP, Followed By The 2012/2013 Seasonal TIV Compared to TIV Prime-Boost in Children/Adolescents Ages 6-17 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine. The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and more durable immune response than is observed in age-matched comparator TIV-TIV groups. |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2012-06-01 |
| 31 | A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate The Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 2 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study. |
NOVAVAX | 2012-05-01 |
| 32 | Phase 2 Observer-Blind, Randomized Trial to Evaluate The Immunogenicity and Safety of PanBlok at Three Dose Levels Adjuvanted With A Stable Oil-in-Water Emulsion Compared With PanBlok Without Adjuvant in Healthy Adults Aged 18 to 49 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation. |
JOHN J TREANOR; | 2012-05-01 |
| 33 | A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate The Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 1 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study. |
NOVAVAX | 2012-04-01 |
| 34 | A Phase I/II, Two-Staged, Single-Center, Randomized, Double-Blind, Antibody Titer Study to Assess Immunogenicity and Safety of FluMist® Intranasal Influenza Vaccine Administered With and Without A TLR-3 Agonist, Ampligen® PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate FluMist with and without Ampligen in healthy volunteers. |
AIM IMMUNOTECH | 2012-04-01 |
| 35 | Characterization of Innate Immune Responses to AS03 Adjuvanted H5N1 Vaccine Compared to Non-adjuvanted H5N1 Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: – Adjuvants are substances included in vaccines that stimulate the immune system and increase the body’s response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in Europe. However, it has not been fully tested in the United States. Researchers want to test the immune responses of people who receive a bird flu vaccine with or without AS03 to better understand how the adjuvant works. This information may help develop better flu vaccines. Objectives: – To compare the healthy immune system responses to bird flu vaccine with or without the AS03 adjuvant. Eligibility: – … |
JOHN S TSANG; | 2012-03-20 |
| 36 | Immunogenicity and Safety Study of A 45 Micrograms Dose of Inactivated, Unadjuvanted H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H5N1 and H7N3 Influenza Vaccines and in H5 and Live Attenuated Vaccine Naïve Individuals PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have previously received one of two versions of an H5N1 vaccine or have previously received an H7N3 vaccine and in people who have not previously received any live attenuated influenza vaccine (LAIV). |
KAWSAR R. TALAAT; | 2011-10-01 |
| 37 | Phase I, Open Label Study to Evaluate Safety, Tolerability and Immunogenicity of Multiple Combinations of H1 and H5 Influenza Hemagglutinin Plasmids Administered ID Followed By in Vivo Electroporation With CELLECTRA®-3P in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase I, parallel design open label study to evaluate safety, tolerability and immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid administered intradermally followed by electroporation in healthy adults |
INOVIO PHARMACEUTICALS | 2011-05-01 |
| 38 | PHASE I, OPEN-LABEL, SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF AN H5 INFLUENZA PLASMID VACCINE (INO-3401) IN HEALTHY ADULTS PREVIOUSLY VACCINATED WITH VGX-3400X PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, INO-3401, which includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, … |
INOVIO PHARMACEUTICALS | 2011-05-01 |
| 39 | A Dose Escalation Phase 1 Safety and Immunogenicity Study of An Oral Viral Vector Vaccine Encoding Avian Influenza H5N1 Hemagglutinin Protein and DsRNA Adjuvant in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study. |
MARTIN KABONGO; | 2011-04-01 |
| 40 | Testing of Respiratory Specimens for The Validation of The QIAGEN ResPlex II Advanced Panel Test and The Artus Influenza A/B RT-PCR Test PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, … |
QIAGEN GAITHERSBURG | 2011-02-01 |
| 41 | Evaluation of The Safety and Cellular and Humoral Immune Response to Primary and Secondary Immunization With Subvirion H5N1 Vaccines Representing Different Clades PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate safety and compare how the body reacts to 2 different strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have received at least 2 doses of the Clade 1 H5N1 vaccine, in a previous National Institute of Health study or who have never received a H5N1 vaccine (naïve). Previously vaccinated subjects (in studies 04-0063, 05-0090, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2010-10-01 |
| 42 | A Multicenter, Open-Label Study to Assess The Immunogenicity and Safety of A Booster Vaccination With A Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With A Two-Vaccination of A Recombinant H5N1 Influenza HA Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447). |
UMN PHARMA | 2010-10-01 |
| 43 | Phase I, Open-Label, Dose Escalation Study to Evaluate The Safety, Tolerability, and Immunogenicity in Healthy Adult Males of A DNA Plasmid Vaccine for HS Avian Influenza (VGX-3400) Administered By Intramuscular (IM) Injection Followed By Electroporation (EP) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Research Hypothesis: VGX-3400 (DNA plasmids encoding the hemagglutinin (HA), neuraminidase (NA), and M2e-NP antigen of the H5N1 avian influenza virus) administered to healthy adult males by IM injection followed by EP will be generally well tolerated and immunogenic. |
MINJA KIM; | 2010-08-01 |
| 44 | Phase 1 Inpatient Study of The Safety and Immunogenicity of One Dose of Live Influenza A Vaccine H7N3 (6-2) AA Ca Recombinant (A/Chicken/British Columbia/CN-6/2004 X A/Ann Arbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H7N3 Infection in The Event of A Pandemic PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains that infect people is important. The purpose of this study is to determine the safety of and immune response of an investigational AI vaccine in healthy adults against the H7N3 strain of avian influenza. |
JOHN TREANOR; | 2010-07-01 |
| 45 | Phase 1 Inpatient Study of The Safety and Immunogenicity of Live Influenza A Vaccine H7N7 (6-2) AA Ca Recombinant (A/Netherlands/219/03 (H7N7) X A/Ann Arbor/ 6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H7N7 Infection in The Event of A Pandemic PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Every year the human population suffers from seasonal outbreaks of influenza resulting in both illness and death. However, the rates of illness and death from seasonal outbreaks are significantly lower than those suffered during times of influenza pandemic, such as those experienced in 1918, 1957, and 1968. The reason for this difference lies in presence of immunity within a population. With seasonal outbreaks of influenza most people have some immunity to the circulating strain and usually only those with weakened immune systems experience serious complications. Influenza pandemics, in contrast, … |
JOHN TREANOR; | 2010-07-01 |
| 46 | Prospective Studies of Avian Influenza Transmission to Humans in Egypt PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The main focus of the study is: – To estimate seroprevalence of AI in poultry-exposed and non-exposed human populations. – To estimate the incidence of AI in poultry-exposed and non-exposed human populations. – To investigate risk factors associated with AI infections in occupationally-exposed poultry workers. The secondary objectives of the study: – To investigate patterns in transmission of AI to household contacts of AI clinical cases – To isolate AI viruses from acute cases – To monitor the pathogenicity and disease severity of AI viruses causing human infections |
GHAZI KAYALI; | 2010-06-01 |
| 47 | Phase I Randomized Study of The Safety, Dose Escalation, and Immunogenicity of Adjuvanted Influenza A/Anhui/05 Boosting in Subjects Previously Immunized With One or Two Doses of A/Vietnam/1203/04 or in Unprimed Individuals and Compared to Placebo PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This research will study safety and the body’s immune (defense system) responses, including anti-H5 flu antibodies (the body’s protective proteins found in the blood), to an inactivated influenza H5 bird flu, virus vaccine. Participants will be assigned by chance to receive the vaccine injections with and without an adjuvant, (substance that can improve vaccine effectiveness so less vaccine may be used) MF59, or placebo (inactive substance). Five different vaccine dose strengths will be evaluated. About 735 healthy participants, ages 18-49 will be asked to take part in this study. Study procedures include physical exam, blood sampling, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2010-06-01 |
| 48 | A Two-Part Placebo-Controlled Evaluation of The Safety and Immunogenicity of An A/Indonesia/5/05 Recombinant Hemagglutinin Influenza H5N1 Vaccine With and Without Glucopyranosyl Lipid A (GLA-SE) in Healthy Adults 18-49 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations. |
MANON M.J. COX; | 2010-06-01 |
| 49 | Phase I, Open-label, Dose Escalation Study to Evaluate The Safety, Tolerability, and Immunogenicity in Healthy Adults of A DNA Plasmid Vaccine for H5 Avian Influenza (VGX-3400X) Administered By Intramuscular (IM) Injection Followed By Electroporation (EP) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, VGX-3400X, which includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, … |
STEVEN HULL; | 2010-06-01 |
| 50 | Collection & Extraction of Respiratory Specimens for The Validation of The Artus Influenza RG PCR Test PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The study will be conducted with nasopharyngeal swab specimens collected prospectively from individuals suspected of having an acute respiratory tract infection caused by an Influenza virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, as well as the CDC swine H1N1 test will be used to establish a collection of well characterized specimens. For each specimen four (4) aliquots will be prepared. One aliquot will be tested in real-time using the requisite viral culture reference methods, one aliquot will be used for H1N1 reference testing, … |
QIAGEN GAITHERSBURG | 2010-03-01 |
| 51 | Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection – A Clinical and Pharmacokinetic Study Related Papers Related Patents Related Grants Related Experts View Highlight: Currently, there is no standard treatment for influenza with related lower respiratory tract infection (LRTI) in children younger than one year of age, even though influenza related LRTI is a potentially fatal illness in these children. This study will test a medicine for influenza in children younger than one year of age to see if it is safe and effective. |
BOB TAYLOR; | 2010-03-01 |
| 52 | Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With A Prime Boost Regimen of Seasonal Influenza Vaccine PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values. |
DELIA B BETHELL; | 2009-11-01 |
| 53 | A Multicenter, Non-Blinded, Dose Escalation Study to Evaluate The Immunogenicity, Safety and Optimal Dose of Three Doses Regimen of Recombinant Influenza H5N1 Vaccine, After Two Vaccinations Given 3 Weeks Apart, in Healthy Young Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults. Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study. |
SUMINOBU ITO; | 2009-10-01 |
| 54 | Avian Influenza Studies In Lebanon PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005 and has since established itself in local domestic birds and is now considered endemic in several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies also provide some evidence suggesting that humans exposed to these sick birds are showing elevated antibody titers against these LPAI H9 viruses. This study will focus on the following objectives: – … |
MOHAMMAD GHAZI KAYALI; | 2009-07-01 |
| 55 | A Study of The Pharmacology of Oseltamivir (Tamiflu) in Pregnancy Related Papers Related Patents Related Grants Related Experts View Highlight: The primary research question of this study is: Does the pharmacokinetics of oseltamivir after a single oral dose differ between the pregnant and non-pregnant women? |
RICHARD BEIGI; | 2009-04-01 |
| 56 | Comparison of The Cellular and The Humoral Immunogenicity As Well As The Safety of Different Trivalent Influenza Vaccines in Healthy Adults Between 18 and 60 Years of Age PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged > 18 and < 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine. |
NATIONAL CENTRE FOR EPIDEMIOLOGY HUNGARY | 2008-11-01 |
| 57 | A Phase II Randomized Study of The Safety and Immunogenicity of Vaccination Strategies Using One or Two Clades and Different Schedules of H5N1 Unadjuvanted, Inactivated Subvirion Influenza Vaccines in H5 Naïve Healthy Adults PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Severe disease in humans due to bird influenza viruses (H5N1) has led to concern that this virus may result in a widespread outbreak of bird flu. The purpose of this study is to evaluate the dose and dosing schedule for 2 different types of H5N1 vaccine. Participants will be randomly assigned to 1 of 9 possible vaccine groups. All participants will receive 2 doses of Clade 1, Clade 2, or combination Clade 1 and 2 on Day 0. All participants will receive a second dose of the same vaccine or a different vaccine type on study day 7, 14, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2008-09-01 |
| 58 | Phase I Inpatient Study of The Safety and Immunogenicity of Live Influenza A Vaccine H6N1 (6-2) AA Ca Recombinant (A/Teal/Hong Kong/W312/1997 (H6N1) X A/Ann Arbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H6N1 Infection in The Event of A Pandemic PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H6N1 influenza vaccine candidate. |
KAWSAR TALAAT; | 2008-09-01 |
| 59 | Host Genetic Susceptibility to Avian Influenza A/H5N1 in Vietnam, Thailand, Indonesia and Singapore PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The identification and characterization of susceptibility loci for H5N1 infection in humans could have profound implications. The detection of host genetic factors may shed light on key pathogenic interactions between H5N1 and human cells, assisting in identifying the viral characteristics determining pandemic potential. In addition, the identification and verification of susceptibility loci would be followed by functional studies which might point the way to new therapeutic and preventive options. The objective of this study is to investigate if host genetic factors are associated with susceptibility to influenza H5N1 illness |
TAWEE CHOTPITAYASUNOND; | 2008-07-01 |
| 60 | A Trial to Evaluate The Immunogenicity of Accelerated Primary Vaccination With Monovalent A/Indonesia/5/05 (H5N1) Vaccine Antigen in Association With AS03 Adjuvant in Adults Aged 18-64 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to characterize the immunogenicity & safety of 2 doses of GSK’s avian flu vaccine GSK 1557484A given according to different regimens to adults aged 18 to 64 years |
GLAXOSMITHKLINE | 2008-06-05 |
| 61 | Efficacy of Oseltamivir in Reducing The Duration of Clinical Illness, Viral Shedding, and Transmissibility Reduction Within Households Among Participants in An Influenza Disease Burden Surveillance Cohort in Urban Dhaka, Bangladesh PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Background In preparation for a global influenza pandemic, there is an urgent need for representative data from populations and settings where the pandemic is most likely to arise. There are no data on oseltamivir efficacy from Asian urban slum populations concerning duration of illness and viral shedding, nor whether efficacy depends on starting treatment < 48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the drug, in such settings, ... |
W. ABDULLAH BROOKS; | 2008-05-01 |
| 62 | Evaluation of The Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok® Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine in Healthy Adults Aged 18 to 49 Years PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of participants. |
JOHN J TREANOR; | 2007-09-15 |
| 63 | A Clinical and Microbiological Study of Acute Respiratory Infections in Refugee Infants Living on The Thai-Burmese Border PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will follow 1000 refugee infants from birth for two years. The aim of the study is to better understand why some children develop infections caused by the bacterium Streptococcus pneumoniae whilst others merely carry this organism asymptomatically at the back of the nose (in the nasopharynx). The investigators will also define which micro-organisms cause lower respiratory tract infections (e.g., pneumonia) in this population in order to implement appropriate interventions (e.g., vaccines). Infants will be reviewed monthly and a nasopharyngeal swab will be taken. A group of 250 mother-infant pairs will be studied in greater detail, … |
FRANCOIS NOSTEN; | 2007-09-01 |
| 64 | A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate The Immunogenicity, Safety and Tolerability of Two Doses of An H5N1 Influenza Vaccine in Subjects Aged 6 Months to 17 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination |
NOVARTIS VACCINES | 2007-09-01 |
| 65 | Phase 1 Inpatient Study of The Safety and Immunogenicity of Live Influenza A Vaccine H7N3 (6-2) AA Ca Recombinant (A/Chicken/British Columbia/CN-6/2004 X A/Ann Arbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for The Prevention of Avian Influenza H7N3 Infection in The Event of A Pandemic PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Over the past decade, avian influenza (AI) has become a major health concern. The development of safe and effective vaccines against avian strains infecting people is important. The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza. |
KAWSAR TALAAT; | 2007-09-01 |
| 66 | A Phase 1, Double-Blinded Study to Evaluate The Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines Administered With The Biojector® 2000 Needle-Free System PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system’s response to the vaccine. The safety and immune system’s response will be studied throughout the trial. |
VICAL | 2007-08-01 |
| 67 | A Phase 1, Double-Blinded Study to Evaluate The Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system’s response to the vaccine. The safety and immune system response will be studied throughout the trial. |
VICAL | 2007-08-01 |
| 68 | Phase I Inpatient Study of The Safety and Immunogenicity of Live Influenza A Vaccine Modified H5N1 (6-2) AA Ca Recombinant (A/Hong Kong/213/2003 X A/AnnArbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H5N1 Infection in The Event of A Pandemic PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Over the past decade, avian influenza (AI) has become a major health concern. The development of a safe and effective vaccine against H5N1 infection is important. The purpose of this study is to determine the safety of a new AI vaccine in healthy adults. |
RUTH A. KARRON; | 2007-06-01 |
| 69 | A Phase II, Single Center, Exploratory Study to Evaluate Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With MF59-adjuvanted or Non-adjuvanted H5N3 Influenza Vaccines PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects |
NOVARTIS VACCINES | 2007-05-01 |
| 70 | Prospective Study of Individuals Exposed to Confirmed Cases of Human Influenza A (H5N1) Infection in China PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to see if people in China who have contact with someone infected with bird flu (H5N1) become infected themselves without necessarily getting sick. Adults and children greater than 1 year of age who have contact with someone infected with bird flu may participate in the study. At the first 1-2 study visits, a blood sample will be taken from volunteers in order to test for antibodies, the part of the blood that fights infection. If the result of the H5N1 antibody test is positive after the 1st or 2nd study visit, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2007-01-01 |
| 71 | Avian/Pandemic Influenza Registry PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a global, multi-center, observational registry of participants with suspected or confirmed infection with avian influenza A H5N1. Data are collected through retrospective abstraction, from detailed case reports that may be published and available in the public domain, or as incident cases received directly from the treating physician or other medical personnel. |
HOFFMANN LA ROCHE | 2007-01-01 |
| 72 | Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity Primary Objective: To describe the safety profile and immunogenicity following each injection. |
SANOFI PASTEUR A SANOFI COMPANY | 2007-01-01 |
| 73 | Matched Case-Control Study of Risk Factors for Human Infection With Avian Influenza A (H5N1) Virus, China PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will determine risk factors of human infection with avian influenza A virus, also known as bird flu virus. Certain risk factors such as exposure to poultry, travel history, health status, and other factors may affect one’s risk of getting bird flu. Study participants will include individuals, older than age 1, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2007-01-01 |
| 74 | Pharmacologic Study of Oseltamivir in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Pharmacologic Study of Oseltamivir in Healthy Volunteers is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, … |
YUPAPORN WATTANAGOON; | 2006-11-01 |
| 75 | Phase 1 Inpatient Study of The Safety and Immunogenicity of H9N2 (6-2) AA Ca Reassortant (A/Chicken/Hong Kong/G9/97 X A/Ann Arbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H9N2 Infection in The Event of A Pandemic (Study B) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Avian influenza (AI), also known as bird flu, has become a major public health concern in many regions of the world. The purpose of this study is to evaluate the safety of and immune response to an AI vaccine in healthy adults. |
RUTH A. KARRON; | 2006-10-01 |
| 76 | A Phase II Vaccine Dose Finding Pilot Study for Development of An Anti-Influenza A (H5N1) Intravenous Hyper-Immune Globulin PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins made by the body that attack the influenza virus. This study will use an experimental bird flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar to the regular influenza vaccine and has been studied in more than 450 people. This study will use high doses of the vaccine to generate high antibody levels that can be collected for producing the new treatment. Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible for this study. Candidates are screened with a medical history and physical examination. Participants are given one of three doses of the vaccine, depending on when they enter the study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated, the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV, hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle aches, or others. At the end of the 7 days, they are contacted by study staff to report the symptoms. In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood test shows moderately high antibody levels. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates the blood cells from the antibodies and protein. The antibodies and protein are collected and the rest of the blood is returned to the body. Subjects are asked to undergo at least three apheresis procedures. … |
H. CLIFFORD LANE; | 2006-08-01 |
| 77 | Phase 1 Inpatient Study of The Safety and Immunogenicity of Live Influenza A Vaccine H5N1 (6-2) AA Ca Recombinant (A/VietNam/1203/2004 X A/AnnArbor/6/60/ca), A Live Attenuated Virus Vaccine Candidate for The Prevention of Avian Influenza H5N1 Infection in The Event of A Pandemic PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The need for a vaccine to prevent the spread of AI among livestock and to humans is sorely needed. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults. |
RUTH A. KARRON; | 2006-06-01 |
| 78 | A Phase I Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate The Safety and Tolerability of Intravenous Peramivir in Healthy Subjects PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the safety and tolerability of peramivir, a new drug to treat influenza. The study will administer gradually increasing doses of the drug in successive small groups of subjects to determine the optimal dose that is safe and well tolerated. It will be studied first at a single dose and then in multiple doses. The study will also determine how long peramivir stays in the body and how high the drug levels are in the blood. Men and women 18 – … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2006-02-23 |
| 79 | High-Dose Versus Standard-Dose Oseltamivir for The Treatment of Severe Influenza and Avian Influenza: A Phase II Double-Blind, Randomized Clinical Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic–worldwide outbreak of disease–with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, … |
JEREMY FARRAR; | 2006-02-01 |
| 80 | Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study may determine whether laboratory studies of people’s blood cells, who have received vaccines against H5 influenza, or bird flu, will help to decide if the vaccines are going to be prevent disease effectively. About 232 people, 18 years and older, enrolled in the studies A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults and in Healthy Elderly Adults will participate. Participants may be involved in this study for about 14 months. Procedures may include blood draws, physical exams, and medical history reviews. |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2005-10-01 |
| 81 | Phase I Inpatient Study of The Safety and Immunogenicity of H9N2 (6-2) AA Ca Reassortant (A/Chicken/Hong Kong/G9/97 X A/Ann Arbor/6/60 Ca), A Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H9N2 Infection in The Event of A Pandemic (Study A) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults. Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide variety of birds and mammals. The direct transmission of avian influenza viruses from birds to humans has recently become a major health concern in Asia and other parts of the world, … |
RUTH A. KARRON; | 2005-06-01 |
| 82 | Oseltamivir (Tamiflu) Dosing Strategies for Use During Influenza Prophylaxis (VA01) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults. |
MARK HOLODNIY; | 2005-02-01 |
| 83 | Contamination During Removal of Two Different Personal Protective Systems When Working Under Conditions Requiring Enhanced Respiratory and Contact Precautions PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Highly communicable and virulent diseases, the ongoing threat of emerging infectious diseases, and the prospect of bio-terrorism have become part of the new reality for health care workers. SARS transmission has occurred despite the use of droplet, contact, … |
JORGE E. ZAMORA; | 2005-01-01 |
| 84 | Evaluation of The Immunogenicity and Safety of Two Preparations of Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly in Healthy Adults Ages 18-49 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to determine the dose-related safety, immunogenicity, and protective efficacy of a trivalent recombinant hemagglutinin influenza vaccine in healthy adults. |
JOHN TREANOR; | 2004-11-01 |