July 7, 2026
New Phase 1 trial launches to evaluate IAVI-developed HIV broadly neutralizing antibody
PedMab1-Ex, led by SAMRC and Ospedale San Raffaele, aims to assess ePGT121v1-LS for eventual use to prevent HIV acquisition by infants and young children.
Despite lifesaving advancements in HIV prevention tools, UNAIDS reports that progress toward reducing HIV transmission in children has largely stalled in recent years. Nearly 120,000 children still acquire HIV each year, often due to exposure during breastfeeding in communities with high HIV circulation. Antiretroviral therapy (ART) for mothers living with HIV can be an effective way to prevent transmission to newborns and nursing babies, but it may not be suitable for all depending on location, cost, access, adherence requirements, and other factors. A new long-acting option to protect infants from HIV transmission during breastfeeding could help to fill critical gaps.
Broadly neutralizing antibodies (bnAbs) could potentially meet key needs by protecting infants from multiple strains of HIV. IAVI and our partners developed a promising bnAb, ePGT121v1-LS, from blood samples taken during Protocol G — a cohort study run by IAVI that collected samples from adult participants living with HIV globally. This antibody was selected for further development following evidence of strong potency in pre-clinical trials.
On July 6, 2026, the South African Medical Research Council (SAMRC) in partnership with the group led by Dr. Gabriella Scarlatti, Group Leader of the Unit of Viral Evolution and Transmission at IRCCS Ospedale San Raffaele, announced the kickoff of a Phase 1 clinical trial to assess the safety and pharmacokinetic profile of ePGT121v1-LS. This trial, PedMAb1-Ex, will first enroll 26 healthy adult volunteers to inform dose selection and administration strategies for the planned infant trial, which will begin after favorable safety data is collected.
IAVI is grateful to all volunteers, partners, and funders involved in this early trial of a bnAb that could prevent postnatal transmission of HIV. The trial will be conducted at the Chatsworth Clinical Research Site at the SAMRC HIV and Other Infectious Diseases Research Unit. Funding for the study is provided by the SAMRC Grants Innovation and Product Development Division and Thrasher Research Fund as part of ongoing efforts to advance innovative HIV prevention strategies. The study is part of the PedMAb consortium, with additional funding from the European and Developing Countries Clinical Trials Partnership (EDCTP).