A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)
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.
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).
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Conditions
Cytomegalovirus Infections
Intervention
AVX601, Placebo, AVX601, Placebo, AVX601, AVX601, AVX601, Placebo
Location
Cincinnati Center for Clinical Research
Cincinnati
Ohio
United States
45229
Status
Completed
Source
AlphaVax, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00439803
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
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