CAPRISA 012A / SAMBA trial I
Status:Completed
Phase:I
Principal Investigator(s):Salim Karim
Objective:The overall goal of the CAPRISA 012 trial is to develop a combination of two anti-HIV mAbs as a new, safe and effective long-acting HIV prevention technology, principally for women. The trial aims to fast-track and efficiently advance passive immunization as an emerging HIV prevention strategy. The aim of Part A CAPRISA 012A (described in this summary) is to determine the safety and pharmacokinetic (PK) profile of the human mAbs VRC07-523LS and PGT121 administered subcutaneously alone and in combination to HIV negative women in South Africa. Forty-five HIV-negative participants were allocated to 9 groups of 5 participants each. In each group, 4 participants were ran-domly assigned to the intervention, VRC07-523LS and/or PGT121 and 1 to placebo . The bnAbs were administered either alone or in combination. Enrollment into consecutive groups occurred in a stepwise, dose-escalation design fol-lowing predetermined safety reviews (Figure 1). Repeat doses in Groups 3, 4, and 6 were administered at 12 or 24 weeks. All study products were administered subcutaneously with a maximum volume of 2 mLs per injection site in the abdominal area using a needle and syringe. In combination groups, each antibody was administered separately at different areas of the abdomen. Results: Administration of the two bNAbs was safe. The levels of VRC07-523LS that were documented were considered acceptable, while PGT121 concentrations were lower, but detectable.Last updated September 13, 2022
Prevention Option(s):Antibody Related Research
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionN=5
VRC07 5mg/kg one dose
Safety pause
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
VRC07 10mg/kg one dose
Random allocation
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
VRC07 5mg/kg repeat dose at 12 weeks
Random allocation
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
VRC07 10mg/kg repeat dose at 24 weeks
Random allocation
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
PGT121 3mg/kg one dose
Random allocation
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
PGT121 3mg/kg repeat dose at 12 weeks
Random allocation
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
PGT121+VRC07 (3mg/kg + 5mg/kg)
One dose
Safety pause
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
PGT121 10mg/kg one dose
Safety pause
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
VRC07 20mg/kg one dose
Safety pause
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
PACTR201808919297244
Trial Sponsors:
EDCTP, SAMRC
Start Date
End Date
October 1, 2018
October 31, 2019
Enrollment:45
Age range:
18 Years ↔
40 Years
Population:Cisgender Women