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A Randomized, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or Combined With Adjuvants in Healthy Adults
This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 394 |
| Start date | 2006-02 |
| Completion | 2006-11 |
Conditions
- Influenza
Interventions
- Aluminum hydroxide
- Inactivated Influenza A/H5N1 Vaccine (Chiron)
- MF-59
- Placebo
Primary outcomes
- Geometric mean titer and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 28 days after receipt of the second dose of vaccine. — Approximately Day 56.
- Adverse event or SAE information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments). — Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208.
- Proportion of subjects in each group achieving a serum neutralizing antibody titer ratio of 1:40 against the influenza A/H5N1 virus 28 days following second dose of vaccine. — Approximately Day 56.
- Proportion of subjects in each dose group achieving a serum hemagglutination (HAI) antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine. — Approximately Day 56.
- Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine. — Approximately Day 56.
Countries
United States