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Evaluation of the Safety and Cellular and Humoral Immune Response to Primary and Secondary Immunization With Subvirion H5N1 Vaccines Representing Different Clades
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, 05-0127) will receive either 15 or 90 mcg of H5N1 vaccine. Multiply boosted volunteers who participated study 05-0043 and received Clade 1 and 3 vaccines, will receive the same dose (15mcg). Vaccine naïve subjects will receive 2 doses of vaccine (15 or 90 mcg) separated by 28 days. Blood samples will be collected. 115 volunteers age 18-64 may participate in study related procedures for approximately 7 months.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 95 |
| Start date | 2010-10 |
| Completion | 2012-02 |
Conditions
- Influenza
Interventions
- Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005
Primary outcomes
- Reactogenicity: Occurrence of vaccine-associated unsolicited adverse events through Day 28 after the last vaccination — Day 0 to Day 28 for primed and boosted subjects and Day 0 to Day 56 for unprimed subjects.
- Reactogenicity: Occurrence of vaccine-associated solicited local and systemic adverse events within 8 days post-vaccination (Day 0-7) — Within 8 days post-vaccination (Day 0-7)
- Reactogenicity: Occurrence of vaccine-associated unsolicited serious adverse events (SAEs) through the course of the study — Day 0 through 6 months after last dose of vaccine (day 180 for primed and boosted subjects and day 208 for non-primed subjects)
Countries
United States