VRC 606

Status:Completed
Phase:I
Principal Investigator(s):Julie E Ledgerwood, D.O.
Objective:To see if VRC01LS is safe and well-tolerated in people. To see what level of VRC01LS is maintained in people and if they develop an immune response to it.Last updated January 21, 2022
Prevention Option(s):Antibody Related Research
Study Design:Open label, Randomized
Arms and Assigned Interventions
Description5 mg/kg/IV on Day 0
Mode of Delivery
ARMsExperimental
Description5 mg/kg SC on Day 0
Mode of Delivery
ARMsExperimental
Description20 mg/kg IV on Day 0
Mode of Delivery
ARMsExperimental
Description40 mg/kg IV on Day 0
Mode of Delivery
ARMsExperimental
Description5 mg/kg SC on Day 0, Week 12 and Week 24
Mode of Delivery
ARMsExperimental
Description20 mg/kg IV on Day 0, Week 12 and Week 24
Mode of Delivery
ARMsExperimental
Results: Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults
Official Code: NCT02599896
Related Publications:
Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1
Enhanced potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo
Enhanced neonatal Fc receptor function improves protection against primate SHIV infection
Trial Sponsors: NIAID
Start Date
End Date
November 16, 2015
July 25, 2018
Enrollment:49
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women