drugset / Trial / NCT00440362
A Phase 1/2 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza
RandomizedParallel-groupTriple-blindPrevention
Summary
AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate vaccine against influenza. The objectives of this Phase 1 study are to test the safety of the vaccine and the immune response to the vaccine in healthy volunteers 18-40 years of age. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on one or two occasions over 2 months. The study will last 4 months and will have a total of 8 visits.
Timeline
- Start
- 2007-04
- Primary completion
- 2007-09
- Completion
- 2007-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AVX502 | Vaccine | 2e+07 iu | Intramuscular |
| Comparator | AVX502 | Vaccine | 2e+08 iu | Intramuscular |