ANRS VRI08 / EHVA P01
Status:
Phase:Open Label
Principal Investigator(s):
Objective:EHVA P01 (European HIV Vaccine Alliance Preventative Trial 01/ANRS VRI08) A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults
EHVA P01 is an international, phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults
Last updated September 30, 2020
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L
0.1mL of DREP-HIV-PT1 will be diluted with saline (Sodium Chloride for Injection, 0.9%) and administered intramuscularly (total volume of 0.5mL) in the LEFT deltoid muscle using a needle-free device (Pharmajet Stratis®)
0.4mL of MPLA-L from a vial containing 0.55mL of MPLA-L (25µg/mL) and add this to a vial containing 0.35mL of CN54gp140 (500µg/mL). The vial contents will be mixed by gentle agitation and 0.45mL of will be withdrawn from the vial to make a concentration of 100µg CN54gp140 and 5µg MPLA-L . The combined products will be injected into the RIGHT deltoid muscle using a needle and syringe.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Drep-HIV-PT1 1.0mg and CN54gp140/MPLA-L
0.5mL of DREP-HIV-PT1 will be administered intramuscularly in the LEFT deltoid muscle using the a needle-free device (Pharmajet Stratis®)
0.4mL of MPLA-L from a vial containing 0.55mL of MPLA-L (25µg/mL) and add this to a vial containing 0.35mL of CN54gp140 (500µg/mL). The vial contents will be mixed by gentle agitation and 0.45mL of will be withdrawn from the vial to make a concentration of 100µg CN54gp140 and 5µg MPLA-L . The combined products will be injected into the RIGHT deltoid muscle using a needle and syringe.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: DNA HIV PT123 4mg and CN54gp140/MPLA-L
1ml of DNA-HIV-PT123 will be injected into the LEFT deltoid muscle using a needle and syringe.
0.4mL of MPLA-L from a vial containing 0.55mL of MPLA-L (25µg/mL) and add this to a vial containing 0.35mL of CN54gp140 (500µg/mL). The vial contents will be mixed by gentle agitation and 0.45mL of will be withdrawn from the vial to make a concentration of 100µg CN54gp140 and 5µg MPLA-L . The combined products will be injected into the RIGHT deltoid muscle using a needle and syringe.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT04844775
Trial Sponsors:
ANRS, Emerging Infectious Diseases
Start Date
End Date
June 1, 2021
June 1, 2023
Enrollment:70
Age range:
18 Years ↔
55 Years
Population:Cisgender Men, Cisgender Women