A Phase 2 interventional study of Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS in To Assess Extended Safety and Tolerability of Subcutaneous CAP256V2LS and VRC07-523LS Monoclonal Antibodies in HIV-negative Women, sponsored by Centre for Infectious Disease Research in Zambia. Completed at 1 site in Zambia. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Centre for Infectious Disease Research in Zambia · Phase 2, Interventional, and Prevention
A double blinded, Randomized, Placebo- controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV- negative women
STUDY SCHEMA
Purpose:
To assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS monoclonal antibodies in HIV-negative women
Study design:
A double blinded, randomized, placebo-controlled phase II trial
Rationale :
Current pharmacokinetic data on CAP256V2LS and VRC07.523LS suggest that plasma antibody concentrations projected out to 120 days and 180 days are above 1 μg/ml. In the macaque model, all animals were protected from challenge at CAP256-VRC26.25-LS plasma concentrations as low as \<0.75 μg/ml. CAP256-VRC26.25-LS was fully protective even at the 0.08 mg/kg dose.
In the absence of a plasma antibody concentration that correlates with protection in humans, this dose-ranging phase II trial will assess safety of CAP256V2LS and VRC07.523LS administered at 4-monthly and 6-monthly dosing intervals, using antibody concentrations and breakthrough HIV infections, if any to guide dose and dosing interval selections for the future phase III trial.
Study participants: HIV negative (N=984) 18 to 30 years.
Study sites:
Study duration :
Enrolment will take place within 56 days of screening.
Study products: CAP256V2LS and VRC07-523LS administered as separate injections
Primary objective:
Secondary objectives:
Exclusion Criteria:
Assign individual study participants to one of the two study arms within a 4- and 6- monthly dosing schedule- two doses.
Biological: Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS
Normal saline SC at 16 or 24week (4 or 6 monthly) dosing intervals
Biological: Broad band monoclonal antibodies named as CAP256V2LS and VRC07- 523LS
HIV prevention
Proportion of participants with any grade 3 or higher reactogenicity events within the first 3 days and adverse events after administration of CAP256V2LS in combination with VRC07-523LS
The aim of the CAPRISA 012C trial is to assess extended safety and obtain an estimate of efficacy in preventing HIV infection in young women by measuring * Proportion of participants with any grade 3 or higher reactogenicity events within the first 3 days after administration of CAP256V2LS in combination with VRC07-523LS * Proportion of participants with any grade 3 or higher adverse events related to the administration of CAP256V2LS in combination with VRC07-523LS
Time frame: 18 months
Plan to share: Undecided
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Centre for Infectious Disease Research in Zambia