EVALUATION OF A BOOSTER DOSE OF A/VIETNAM/1203/04 (H5N1) VACCINE ADMINISTERED

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This proposal describes a multicenter randomized, double-blinded, study of A/H5N1 influenza vaccine in approximately 400 healthy adults 18-65 years of age, inclusive. Participants will have already taken part in an earlier study of this vaccine (Project 10410-01[104]) and received two doses of the A/H5N1 vaccine, one month apart. Participants who received placebo in the earlier study will not participate. The final visit for study 10410-01(104) will be conducted at the same time as the first visit for this study 10410-01(108). At this site, it is anticipated that up to 140 adults will be eligible to take part in the study. Participants will receive a single injection of the same dose of the A/H5N1 influenza vaccine that they received in the earlier study (either 7.5, 15, 45, or 90 ¿g) by intramuscular injection in the upper arm. This third dose will be approximately 6 months after the previously received second dose. All study staff will be blinded except the unblinded nurse vaccinator. Participants will receive the vaccine injection followed by a 7-day safety assessment period. Symptoms and signs will be assessed in the clinic for 15-30 minutes after inoculation, and the subjects will maintain a diary card (also called a memory aid) to record oral temperature and systemic and local adverse events (AE) for 7 days after the immunization. All subjects will receive a safety follow-up telephone call at 1-3 days and 13-19 days after vaccination to collect AE information. A blood sample will be obtained 28 days and 180 days after vaccination to measure the antibodies produced by the vaccine. (A pre-vaccination blood sample will have been collected as the final study activity for study 10410-01[104]). The antibody tests will be performed in a central laboratory. The primary outcome measures will be the frequency and severity of AEs in each dose group and the proportions of subjects who achieve a predefined level of protective antibody against A/H5N1 flu.