ANRS VRI01
Phase I/II open-label randomized multicenter trial to assess immunogenicity and safety of 4 prime-boost combinations of HIV vaccine candidates (MVA HIV-B/LIPO-5; LIPO-5/MVA HIV-B; GTU-MultiHIV B/LIPO-5; GTU-MultiHIV B/MVA HIV-B) in healthy volunteers at low risk of HIV infection
Topic
HIV vaccines in healthy volunteers
Sponsor
Inserm-ANRS
Coordinating investigator
Jean-Daniel Lelièvre MD, PhD-AP-HP
Short description
ANRS VRI01 is an open-label, multicentre, randomized trial in 92 healthy participants at low risk of HIV infection in France, with 4 parallel arms, including a phase I safety assessment of MVA HIV-B as well as a phase II efficacy (immunogenicity) assessment in each of the four arms.
Study design
Phase I/II, multicenter, national, open-label, randomized trial HIV including 4 prophylactic prime-boost HIV vaccines strategies
Primary objective
The co-primary objectives are :
- to evaluate the safety of MVA HIV-B and
- to discard vaccine strategies with an insufficient level of immunogenicity, defined by HIV-specific IFN-γ-ELISPOT responses, among 4 HIV prophylactic prime-boost combinations (MVA HIV-B/LIPO-5; LIPO-5/MVA HIV-B; GTU-MultiHIV B/LIPO-5; GTU-MultiHIV B/MVA HIV-B) in healthy volunteers at low risk of HIV infection
Primary endpoint
- MVA HIV-B safety endpoint :
Proportion of participants without any grade 3 or 4 adverse events (clinical or biological) related to MVA-vaccine immunisation, reported from W0 to W2 in arm 1. - Efficacy (immunogenicity) endpoint :
Proportion of participants with a HIV-specific IFN-γ ELISPOT response in each of the 4 arms, defined by a positive response to at least one of the stimulating HIV peptide pools (15-mer pools covering Env, Gag, Pol, and Nef) measured in stimulated PBMC by a standard IFN-γ ELISPOT assay at W30, i.e. 2 weeks after the last vaccine immunisation.
Study population
Volunteers at low risk to contract HIV, age between 21 and 50 years
Intervention
Volunteers meeting the eligibility criteria are randomly allocated in a 1:1:1:1 ratio at trial entry to start one of the following open-label HIV vaccine strategies :
- MVA HIV-B/LIPO-5 (arm 1)
- LIPO-5/MVA HIV-B (arm 2)
- GTU-MultiHIV B/LIPO-5 (arm 3)
- GTU-MultiHIV B/MVA HIV-B (arm 4)
Number of subjects
92 participants
Participating country(ies) and sites
France (4 sites)
Study duration
108 weeks
Funding
Inserm – ANRS | MIE and the VRI.
Supported by the Investissements d’Avenir program managed by the ANR under reference ANR-10-LABX-77-01.
UMS MART activities
Methodological aspects, trial coordination, monitoring, data management and statistical analysis