Safety Study of an Oral Vaccine to Prevent Avian Influenza
Avian InfluenzaBird FluThe 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.
H5N1 Mix and Match With MF59
InfluenzaApproximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2 doses separated by approximately 21 days.
Safety and Immunogenicity of a Live Attenuated H7N9 Influenza Virus Vaccine in Healthy Adults
Influenza A VirusH7N9 SubtypeH7N9 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.
Safety Trial of Live Attenuated Influenza (H7N3) Vaccine
InfluenzaAvian InfluenzaThe study hypothesis is that two doses of cold-adapted, live monovalent A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in healthy adults.
Evaluating the Safety and Immunogenicity of a H7N9 Vaccine for the Prevention of Influenza H7N9...
Influenza A VirusH7N9 SubtypeH7N9 viruses have caused an outbreak of severe respiratory disease in 2013-2014 in China that affected many older adults. This study will evaluate the safety of and immune response to a live attenuated H7N9 vaccine in adults 50 to 70 years old.
A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1
Avian InfluenzaThis 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, or approximately 13 months from the first dose.
Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49...
InfluenzaThe purpose of this study is to test an investigational vaccine known as "VAX161C." An "investigational" vaccine is one that is not licensed for commercial use in the by the United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate wants to find out how safe these doses of vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of the vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how the body recognizes and defends itself against the influenza virus.
H7N9 Mix and Match With MF59 in Healthy Adults
InfluenzaThis is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). Subjects will receive two doses via intramuscular injection, approximately 21 days apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. The duration of the study for each subject will be approximately 13 months.
H5N1 Priming and Boosting Strategies
InfluenzaSevere 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, 28 or 180. Study participants will include about 500 healthy adult subjects, ages 18-49 years old, who have no history of prior H5 flu exposure or vaccination. Study procedures may include medical history, physical exam, and blood sampling. Subject participation may last up to 372 days. Several DMID studies have recently evaluated H5N1 vaccines in healthy adults, 04-063, 05-0090, 05-0015, and 05-0043.
Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted...
InfluenzaOrthomyxoviridae InfectionsFollowing the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.