CAPRISA 012B / SAMBA trial II
Status:Ongoing
Phase:I
Principal Investigator(s):Salim S Abdool Karim
Objective:A Phase I Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of a Human Monoclonal Antibody, CAP256V2LS (VRC-HIVMAB0102-00-AB) administered intravenously to HIV-negative and HIV-positive women or subcutaneously alone and in combination with VRC07- 523LS and /or PGT121 to HIV-negative women in South Africa. CAPRISA 012B, described here, is a phase I trial that evaluates the safety and PK of CAP256V2LS. Based on these phase I studies, a bnAb combination will be selected and evaluated in a larger CAPRISA 012C phase II trial. This trial will determine the extended safety and efficacy in preventing HIV infection in young women.Last updated September 14, 2022
Prevention Option(s):Antibody Related Research
Study Design:Randomized
Arms and Assigned Interventions
DescriptionN=22
Group 1 Dose escalation of IV administration of CAP256V2LS 5 mg/kg -20mg/kg IV one dose
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionN=24
Group 2 Dose escalation of SC administration of CAP256V2LS 5 -20mg/kg SC one dose one dose 16 weeks apart 24 weeks apart CAP256V2LS hyaluronidase
Mode of DeliverySubcutaneous
ARMsActive Comparator
DescriptionN=15
Group 3 Dose escalation of the two antibody combinations 10-20mg/kg SC one dose CAP256V2LS+PGT121+VRC07-523.LS; hyaluronidase placebo
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionN=5
Group 4 Three antibody combination 20mg/kg SC+5mg/kg SC+20mg/kg SC one dose CAP256V2LS+PGT121+VRC07-523.LS; hyaluronidase placebo
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
PACTR202003767867253
Trial Sponsors:
EDCTP, SAMRC
Start Date
End Date
April 1, 2020
December 31, 2022
Enrollment:0
Age range:
18 Years ↔
45 Years
Population:Cisgender Women