NCT00439803

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

A Single-Site, Phase 1, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Cytomegalovirus Genes (AVX601) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AlphaVax, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled Phase 1 study of the safety and immunogenicity of AVX601 vaccine at two dosage levels and two routes of administration in healthy volunteers conducted at a single research center. A total of 40 participants will be enrolled into two groups of 20 participants each. Within each group, participants will be randomized to receive the active vaccine by IM injection (N = 8) or SC injection (N = 8) or to receive a placebo by IM injection (N = 2) or SC injection (N = 2). Each participant will receive a total of six injections of vaccine or placebo, two at each visit at Weeks 0, 8 and 24, administered by a study nurse in an outpatient setting, and will be followed for 12 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 CMV by ELISA and neutralization assays and to the vaccine vector by a VRP neutralization assay) and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to CMV peptides).

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-02-26
• Last updated: 2008-11-10

Locations

1 site across 1 country: United States