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

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.

Conditions

• Influenza

Interventions

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

Sponsors & Collaborators

• AlphaVax, Inc.

  lead INDUSTRY

Principal Investigators

• Robert A Olmsted, Ph.D. · AlphaVax, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2007-09-30

Completion

2007-09-30

Countries

• United States

Study Locations