Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT02568215
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • VRC01 — BIOLOGICAL
    Administered by IV infusion; total dose will vary based on participant's weight
  • Placebo for VRC01 — BIOLOGICAL
    Sodium Chloride for Injection USP, 0.9%; administered by IV infusion

Study Details

This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.

Key Dates

Start date
May 31, 2016
Status verified
Feb 2022
Primary completion
Mar 3, 2021
Completion
Mar 3, 2021

Study Design

Enrollment
1,924 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1: Low-Dose VRC01
    Participants will receive an IV infusion of 10 mg/kg of VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.
  • Experimental: Group 2: High-Dose VRC01
    Participants will receive an IV infusion of 30 mg/kg of VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.
  • Placebo Comparator: Group 3: Placebo for VRC01
    Participants will receive an IV infusion of placebo for VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.

Primary Outcome Measure

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness [ Time Frame: Measured through 3 days after each infusion at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, 72. ]

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