SAMBULELO Phase II double blind randomised placebo-controlled clinical trial.
There is increasing evidence that antibody, in particular neutralizing antibody, has the potential to prevent infection with HIV. This study will provide information on the safety and levels of one such neutralizing antibody in babies, paving the way to further studies.
Main content
A new category of medicines, broadly neutralizing monoclonal antibodies (bNAbs), stop the virus before it enters a cell, and thus work like vaccination. bNAbs last for a long time in the blood. This means that they do not have to be given every day – this is different from ARVs which need to be taken every day.
The study aims to characterize the safety and pharmacokinetics of the long-acting broadly neutralizing HIV antibody (bNAb) VRC07-523LS among breastfed HIV-exposed uninfected infants and HIV-infected breastfed infants receiving standard of care ART for prophylaxis or treatment.
These results will allow us to do larger studies to measure whether these antibodies prevent HIV transmission from mother-to-baby and whether they are useful in treating HIV-infected children.
The SAMBULELO Trial is complementary to another trial conducted by the same investigators, the Phase 1/2 PedMAb study. These two trials are meant to prepare for a phase 3 tolerance and efficacy trial.
About the project
Project name: SAMBULELO, a Phase II double blind randomized placebo-controlled clinical trial to evaluate the safety & pharmacokinetics of VRC07-523LS in breastfed HIV-exposed uninfected and HIV-infected neonates and infants in South Africa
Period: 2022-2024
Leader at UiB: Thorkild Tylleskär
Funder: South African Medical Research Council (SAMRC) and ANRS-MIE, France
Partners:
Pathogenesis and Control of Chronic and Emerging Infections (PCCEI), INSERM, France
South African Medical Research Council HIV and other Infectious Diseases Research Unit (HIDRU)
University of Pretoria, South Africa
University of Bergen, Norway
Ospedale San Raffaele srl, Italia
Main country: South Africa
