Trials / Completed
CompletedNCT01657929
H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Access to Advanced Health Institute (AAHI) · Academic / Other
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | H5-VLP + GLA-AF | H5-VLP antigen and GLA-AF adjuvant. 2 injections at Days 0, and 21. |
| BIOLOGICAL | H5-VLP alone | H5-VLP antigen alone. 2 injections at Days 0, and 21. |
| BIOLOGICAL | H5-VLP + Alhydrogel(R) | H5-VLP antigen and Alhydrogel(R) adjuvant. 2 injections at Days 0, and 21. |
| BIOLOGICAL | Licensed H5N1 vaccine | Licensed H5N1 vaccine. 2 injections given on Days 0 and 21. |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2014-01-01
- Completion
- 2014-01-01
- First posted
- 2012-08-06
- Last updated
- 2014-02-26
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01657929. Inclusion in this directory is not an endorsement.