The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Volunteers will be followed during 72 weeks.
Methods: randomised phase I/II international trial with a parallel group design, open to participants and investigators but blind to laboratory personnel, in healthy volunteers. Vaccines strategies: 70 volunteers will receive 3 DNA-C vaccinations and 1 NYVAC-C vaccination; 70 volunteers will receive 2 DNA-C vaccinations and 2 NYVAC-C vaccination. DNA-C: 2x2ml intra muscular in right and left vastus lateralis; NYVAC-C: 1 ml intramuscular in non-dominant deltoid. Main outcome: 1. the presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays: * in response to env plus at least one of the gag, pol, nef peptide pools, * at weeks 26 or 28; 2. the safety parameters. Secondary outcomes: * cellular responses, * antibody responses, * all grade 1 and 2 adverse events, * all events including those considered unrelated. Sample size: 140 volunteers Enrollment period: 9 months Patient's participation duration: 78 weeks Study duration: 27 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
147
Hôpital Henri Mondor
Créteil, France
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland
Immunogenicity parameter: presence of CD8/CD4+ T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays, in response to env plus at least one of the gag, pol, nef peptide pools
Time frame: week 26 and week 28
Safety parameter: grade 3 or above local adverse event, grade 3 or above systemic adverse event, grade 3 or above other clinical or laboratory adverse event,any event attributable to vaccine leading to discontinuation of the immunisation regimen.
Time frame: within 72 weeks
Cellular responses: CD8/CD4+ T cell mean IFNgamma Spot Forming Units (SFU) per million cells across the peptide pools
Time frame: at weeks 26 and 28
Cellular responses: CD8/CD4+ T cell mean Spot Forming Units (SFU) per million cells across the peptide pools
Time frame: at any week following the first immunisation including weeks 48 and 72
Cellular responses: mean proportion of CD4/CD8+ T cells producing IL-2 and/or IFNgamma following ex-vivo stimulation with HIV-1 peptide pools
Time frame: at weeks 26 and 28, 48 and 72
Cellular responses: number of different epitopes that can be characterised
Time frame: to be determined at a later stage
Antibody responses
Time frame: to be determined at a later stage
All grade 1 and 2 adverse events
Time frame: within 72 weeks
All events including those considered unrelated
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: within the 72 weeks