HIV vaccines in healthy volunteers

Inserm-ANRS

Yves LEVY MD, PhD-AP-HP / Jean-Daniel LELIEVRE MD, PhD-AP-HP

ANRS VRI06 is a first-in-human phase I dose-escalation trial of the Hiltonol®-adjuvanted CD40.HIVRI.Env vaccine, used alone or combined with a fixed dose of DNA-HIV-PT123 vaccine. The primary objective is the assessment of the safety of different doses alone and in combination. Immunogenicity of the vaccine strategies will be explored as secondary objectives.

Multicenter double-blind placebo controlled phase I dose-escalation trial to evaluate different dose levels of CD40.HIVRI.Env (adjuvanted with Hiltonol®) alone and in co-administration with DNA-HIV-PT123

To assess the safety of three dose levels of CD40.HIVRI.Env (0.3; 1; 3 mg) adjuvanted with poly-ICLC (Hiltonol®), alone and in combination with DNA-HIV-PT123, administered at W0, W4 and W24 in healthy volunteers

Proportion of participants without any grade 3 or 4 biological or clinical solicited local/systemic or unsolicited AEs between W0 and W48 (6 months after the last IMP administration), considered to be related or possibly related to IMP administration

Healthy adult volunteers at low risk for HIV transmission, age between 18 and 65 years

Enrolment of a given group will open sequentially depending on the « go-criterion » based on the safety data of the preceding group(s). Within each group, volunteers will be randomized in a double blind manner to active intervention or placebo in a 5:1 ratio

72 healthy participants recruited into 6 groups

France, 2 sites and Switzerland, 1 site

39 months

Inserm – ANRS | MIE and the VRI.
Supported by the Investissements d’Avenir program managed by the ANR under reference ANR-10-LABX-77.

Methodological aspects, trial coordination, monitoring, data management and statistical analysis

https://clinicaltrials.gov/ct2/show/NCT04842682