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Sponsored by: |
AlphaVax, Inc. |
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Information provided by: | AlphaVax, Inc. |
ClinicalTrials.gov Identifier: | NCT00440362 |
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.
Condition | Intervention | Phase |
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Influenza |
Biological: AVX502 Biological: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Single-Site, Phase 1/2, Double-Blind, Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza A/Wyoming/03/2003 Hemagglutinin (AVX502) in Healthy Volunteers |
Enrollment: | 216 |
Study Start Date: | April 2007 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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T1: Active Comparator |
Biological: AVX502
1 dose at 2e7 IU given at T=0 via the IM route
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T2: Active Comparator |
Biological: AVX502
1 dose at 2e8 IU given at t=0 via IM route
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T3: Active Comparator |
Biological: AVX502
1 dose at 2e7 IU given at t=0 via the SC route
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T4: Active Comparator |
Biological: AVX502
1 dose at 2e8 IU given at T=0 via the SC route
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T5: Active Comparator |
Biological: AVX502
2 doses at 2e7 IU given at T=0 and 8 weeks via the IM route
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T6: Active Comparator |
Biological: AVX502
2 doses at 2e8 IU given at T=0 and 8 weeks via the IM route
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T7: Active Comparator |
Biological: AVX502
2 doses of 2e7 IU given at t=0 and 8 weeks via the SC route
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T8: Active Comparator |
Biological: AVX502
2 doses at 2e8 IU given at T=0 and 8 weeks via the SC route
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C1: Placebo Comparator |
Biological: Placebo
1 dose of placebo given at T=0 via the IM route
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C2: Placebo Comparator |
Biological: Placebo
1 dose of placebo given at T=0 via the SC route
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C3: Placebo Comparator |
Biological: Placebo
2 doses of placebo given at T=0 and 8 weeks via the IM route
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C4: Placebo Comparator |
Biological: Placebo
2 doses of placebo given at T=0 and 8 weeks via the SC route
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This is a randomized, double-blind, placebo-controlled Phase 1/2 study of the safety and immunogenicity of AVX502 vaccine at two dosage levels and two routes of administration in healthy volunteers conducted at a single research center. A total of 216 participants will be enrolled. Participants will be randomized to receive active vaccine at one of two dosage levels or placebo in a 4:4:1 ratio. Within each active dosage level or placebo subgroup, participants will be randomized to receive their injections by either IM or SC injection in a 1:1 ratio, and will also be randomized to receive either 1 injection (at Week 0) or 2 injections (1 at each of two visits at Weeks 0 and 8) in a 1:1 ratio. Vaccine will be administered by a study nurse in an outpatient setting and all participants will be followed for 4 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 HA by ELISA and hemagglutination inhibition assays and to the vaccine vector by a VRP neutralization assay) and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to HA peptides).
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AlphaVax, Inc. ( Robert Olmsted, Ph.D. ) |
Study ID Numbers: | AVX502-002 |
Study First Received: | February 23, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00440362 |
Health Authority: | United States: Food and Drug Administration |
Influenza Flu A/Wyoming/03/2003 Alphavirus |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |