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A Phase 1, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the H5-VLP + GLA-AF Pandemic Influenza Vaccine in Healthy Adult Subjects
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pandemic influenza. The vaccine, identified as H5-VLP + GLA-AF, consists of a recombinant influenza virus H5 protein (hemagglutinin from A/Indonesia/5/2005) produced in a plant-based expression system assembling into virus-like particles together with the adjuvant GLA-AF.
Details
| Lead sponsor | Access to Advanced Health Institute (AAHI) |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 105 |
| Start date | 2012-09 |
| Completion | 2014-01 |
Conditions
- Influenza A Subtype H5N1 Infection
Interventions
- H5-VLP + GLA-AF
- H5-VLP alone
- H5-VLP + Alhydrogel(R)
- Licensed H5N1 vaccine
Primary outcomes
- Number of patients experiencing adverse events — 385 days
To evaluate the safety and tolerability of 20 μg of H5-VLP together with 2.5 μg of GLA-AF compared to 20 µg of H5-VLP alone, 20 µg of H5-VLP with 1 mg Alhydrogel(R), or a licensed H5N1 vaccine following intramuscular or intradermal administration on Days 0 and 21. The safety assessments will be based on local and systemic reactions, including reported adverse events, changes in laboratory values, and changes in vital signs. The severity and relationship to treatment will be recorded for all adverse events.
Countries
United States