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Sponsored by: |
AlphaVax, Inc. |
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Information provided by: | AlphaVax, Inc. |
ClinicalTrials.gov Identifier: | NCT00439803 |
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.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Infections |
Biological: AVX601 Biological: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Single-Site, Phase 1, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Cytomegalovirus Genes (AVX601) in Healthy Volunteers |
Enrollment: | 40 |
Study Start Date: | April 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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T1: Active Comparator |
Biological: AVX601
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route
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C1: Placebo Comparator |
Biological: Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
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T2: Active Comparator |
Biological: AVX601
3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route
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C2: Placebo Comparator |
Biological: Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
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T3: Active Comparator |
Biological: AVX601
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route
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C3: Placebo Comparator |
Biological: AVX601
3 doses of placebo given at T=0, 8, 24 weeks via the IM route
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T4: Active Comparator |
Biological: AVX601
3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route
|
C4: Placebo Comparator |
Biological: Placebo
3 doses of placebo given at T=0, 8, 24 weeks via the SC route
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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).
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Acceptable laboratory parameters:
Exclusion Criteria:
Psychiatric condition that may interfere with the ability to comply with the protocol requirements.
Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years.
United States, Ohio | |
Cincinnati Center for Clinical Research | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | Robert A Olmsted, Ph.D. | AlphaVax, Inc. |
Responsible Party: | AlphaVax, Inc. ( Robert A. Olmsted, Ph.D. ) |
Study ID Numbers: | AVX601-001 |
Study First Received: | February 23, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00439803 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CMV cytomegalovirus Alphavirus |
Virus Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections |
Healthy Cytomegalovirus Herpesviridae Infections |
Virus Diseases Cytomegalovirus Infections DNA Virus Infections Infection Herpesviridae Infections |