Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440362
Status:
COMPLETED
Last Update Posted:
2008-11-10
First Post:
2007-02-23
Brief Title:
A Phase 12 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza
Sponsor:
AlphaVax Inc
Organization:
AlphaVax Inc
Study Overview
Official Title:
A Single-Site Phase 12 Double-Blind Safety and Immunogenicity Trial of an Alphavirus Replicon Vaccine Expressing Influenza AWyoming032003 Hemagglutinin AVX502 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This is a randomized double-blind placebo-controlled Phase 12 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 441 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 11 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None