NCT00440362

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

A Single-Site, Phase 1/2, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: AlphaVax, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled Phase 1/2 study of the safety and immunogenicity of AVX502 vaccine at two dosage levels and two routes of administration in healthy volunteers conducted at a single research center. A total of 216 participants will be enrolled. Participants will be randomized to receive active vaccine at one of two dosage levels or placebo in a 4:4:1 ratio. Within each active dosage level or placebo subgroup, participants will be randomized to receive their injections by either IM or SC injection in a 1:1 ratio, and will also be randomized to receive either 1 injection (at Week 0) or 2 injections (1 at each of two visits at Weeks 0 and 8) in a 1:1 ratio. Vaccine will be administered by a study nurse in an outpatient setting and all participants will be followed for 4 months after the first immunization. Safety data will include local and systemic reactogenicity after each dose of vaccine, collected in a systematic format using a subject memory aid and a standard grading scale, specific safety laboratory parameters and general AEs. Immunogenicity data will be obtained by collecting blood at defined time points before and after immunization and separating serum (for measurement of antibodies to HA by ELISA and hemagglutination inhibition assays and to the vaccine vector by a VRP neutralization assay) and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to HA peptides).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	AVX502	1 dose at 2e8 IU given at t=0 via IM route
BIOLOGICAL	AVX502	1 dose at 2e7 IU given at T=0 via the IM route
BIOLOGICAL	AVX502	1 dose at 2e7 IU given at t=0 via the SC route
BIOLOGICAL	AVX502	1 dose at 2e8 IU given at T=0 via the SC route
BIOLOGICAL	AVX502	2 doses at 2e7 IU given at T=0 and 8 weeks via the IM route
BIOLOGICAL	AVX502	2 doses at 2e8 IU given at T=0 and 8 weeks via the IM route
BIOLOGICAL	AVX502	2 doses of 2e7 IU given at t=0 and 8 weeks via the SC route
BIOLOGICAL	AVX502	2 doses at 2e8 IU given at T=0 and 8 weeks via the SC route
BIOLOGICAL	Placebo	1 dose of placebo given at T=0 via the IM route
BIOLOGICAL	Placebo	1 dose of placebo given at T=0 via the SC route
BIOLOGICAL	Placebo	2 doses of placebo given at T=0 and 8 weeks via the IM route
BIOLOGICAL	Placebo	2 doses of placebo given at T=0 and 8 weeks via the SC route

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-02-27
• Last updated: 2008-11-10

Locations

1 site across 1 country: United States