Clinical trial NCT04844775: 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
Official title: EHVA P01/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
Conditions: Healthy Adults
Summary: 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.
Interventions:
description: 1. Drep-HIV-PT1 The DREP-HIV-PT1 is a vaccine designed to elicit an immune response against human immunodeficiency virus-1 (HIV-1) and prevent infection by HIV-1 and/or disease caused by HIV-1. It is an alphavirus-based DNA replicon in which the sequences coding for the viral capsid and envelope have been replaced by the sequences encoding HIV-1 gp140 (96ZM651) antigen.<br/>2. CN54gp140+MPLA-L. Recombinant CN54gp140 is a HIV-1 envelope protein from the clade C strain 97/CN/54 isolate, which comprises a sequence of 634 amino acids. MPLA is a non-toxic version of LipoPolySaccharide (LPS), which is isolated from the LPS lipid A region of Salmonella Minnesota R595 and retains the immune-stimulatory properties of LPS, but exhibits low toxicity.
name: Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L
type: Biological
description: 1. Drep-HIV-PT1 1mg (see above)<br/>2. Drep-HIV-PT1 1mg (see above)
name: DREP-HIV-PT1 1mg and CN54gp140/MPLA-L (see above)
type: Biological
description: 1. DNA-HIV-PT123 HIV vaccine includes three DNA plasmids that encode clade C ZM96 Gag, clade C ZM96 Env, and CN54 Pol-Nef<br/>2. CN54gp140/MPLA-L Recombinant CN54gp140 is a HIV-1 envelope protein from the clade C strain 97/CN/54 isolate, which comprises a sequence of 634 amino acids. MPLA is a non-toxic version of LipoPolySaccharide (LPS), which is isolated from the LPS lipid A region of Salmonella Minnesota R595 and retains the immune-stimulatory properties of LPS, but exhibits low toxicity.
name: DNA-HIV-PT123 4mg and CN54gp140/MPLA-L
type: Biological
Study arms:
design_group_description: 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®)<br/>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.
design_group_title: Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L
design_group_type: Experimental
design_group_description: 0.5mL of DREP-HIV-PT1 will be administered intramuscularly in the LEFT deltoid muscle using the a needle-free device (Pharmajet Stratis®)<br/>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.
design_group_title: Drep-HIV-PT1 1.0mg and CN54gp140/MPLA-L
design_group_type: Experimental
design_group_description: 1ml of DNA-HIV-PT123 will be injected into the LEFT deltoid muscle using a needle and syringe.<br/>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.
design_group_title: DNA HIV PT123 4mg and CN54gp140/MPLA-L
design_group_type: Experimental
Sponsor: France Recherche Nord & Sud SIDA HIV-Hepatites
Collaborators: Chelsea & Westminster Hospital
The Medical Research Council
University College London Hospitals NHS Foundation Trust
Centre hospitalier universitaire Henri-Mondor
EuroVacc Foundation
Imperial College London
Drug name mappings:
name: DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases)
lang: EN
name: Drep-HIV-PT1
lang: EN
name: CN54gp140(Imperial College London)
lang: EN