drugset / Trial / NCT01657929
H5-VLP + GLA-AF Vaccine Trial in Healthy Adult Volunteers
Phase 1
Completed
105 enrolled
Access to Advanced Health Institute (AAHI)
Defense Advanced Research Projects Agency · collabMedicago · collab
RandomizedSingle-groupSingle-blindPrevention
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alhydrogel(R) | Unknown | 1 mg | Intramuscular |
| Subject | GLA-AF | Other / unclassified | 2.5 ug | Other |
| Subject | H5-VLP | Vaccine | 20 ug | Other |
| Comparator | Licensed H5N1 vaccine | Vaccine | 90 ug | — |