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A Phase I, Dose-Ranging Safety and Immunogenicity Study of an Adenovirus-vectored Intranasal, Pandemic (Hemagglutinin H5) Influenza Vaccine, ADhVN1203/04.H5, in Healthy Adults
The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. Single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies. The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
Details
| Lead sponsor | Altimmune, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 48 |
| Start date | 2008-10 |
| Completion | 2011-12 |
Conditions
- Influenza A Subtype H5N1 Infection
Interventions
- Pandemic Influenza Vaccine
- Placebo
Primary outcomes
- To assess the safety of a nasally administered adenovirus-vectored pandemic influenza vaccine in healthy human adults. — 56 day observations with 2 year follow-up
Countries
United States