drugset / Trial / NCT00440362

A Phase 1/2 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza

NCT00440362 ↗

Phase 1/2 Completed 216 enrolled AlphaVax, Inc.
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

EvaluationDrugModalityDoseRoute
Comparator AVX502 Vaccine 2e+07 iu Intramuscular
Comparator AVX502 Vaccine 2e+08 iu Intramuscular

Indications