ANRS VRI06
Status:Ongoing
Phase:I
Principal Investigator(s):Yves LEVY, Jean-Daniel LELIEVRE
Objective:A Phase I Multicenter Double-blind Placebo Controlled Dose Escalation Trial of an Adjuvanted Anti-CD40 mAb Fused to Env GP140 HIV Clade C ZM-96 (CD40.HIVRI.Env) Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Participants
A total of 72 eligible healthy participants will be recruited into 6 groups. Within each group, participants will be randomized in a double blind manner to active intervention or placebo in a 5:1 ratio. Enrolment into a given group (other than group "Solo 0.3") will open sequentially depending on the " go-criterion " based on the safety data of the preceding group(s).
The primary objective is 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 weeks 0, 4 and 24 in healthy participants.
Secondary objectives are to assess the capacity of poly-ICLC-adjuvanted CD40.HIVRI.Env alone and in combination with DNA-HIV-PT123 to elicit immune responses against HIV (immunogenicity):
Humoral (antibody) responses ;
B-cell responses ;
T-cell responses.
Last updated September 19, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Active intervention
Solo groups : CD40.HIVRI.Env vaccine (solution at 5.0 mg/ml) adjuvanted with Poly-ICLC (Hiltonol, solution at 1.8 mg/ml)
Combi groups : CD40.HIVRI.Env vaccine (solution at 5.0 mg/ml) adjuvanted with Poly-ICLC (Hiltonol, solution at 1.8 mg/ml) and combined with DNA-HIV-PT123 HIV-1 vaccine (solution at 4.0 mg/ml)
Mode of DeliveryIntramuscular, Subcutaneous
ARMsExperimental
Official Code:
https://clinicaltrials.gov/ct2/show/NCT04842682
Trial Sponsors:
ANRS, Emerging Infectious Diseases
Start Date
End Date
March 29, 2021
September 30, 2024
Enrollment:72
Age range:
18 Years ↔
65 Years
Population:Cisgender Men, Cisgender Women