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A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)

NCT00439803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-11-10

No results posted yet for this study

Summary

AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and IE1) is a candidate vaccine against cytomegalovirus (CMV).

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 who have not previously been infected with CMV. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in each arm on three occasions over 6 months. The study will last 12 months and will have a total of 12 visits.

Conditions

  • Cytomegalovirus Infections

Interventions

BIOLOGICAL

AVX601

3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route

BIOLOGICAL

Placebo

3 doses of placebo given at T=0, 8, 24 weeks via the IM route

BIOLOGICAL

AVX601

3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route

BIOLOGICAL

Placebo

3 doses of placebo given at T=0, 8, 24 weeks via the SC route

BIOLOGICAL

AVX601

3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route

BIOLOGICAL

AVX601

3 doses of placebo given at T=0, 8, 24 weeks via the IM route

BIOLOGICAL

AVX601

3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route

BIOLOGICAL

Placebo

3 doses of placebo given at T=0, 8, 24 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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439803 on ClinicalTrials.gov