The aim of PedMAb – a Euro-African research project – is to ensure the development of a promising strategy to prevent mother-to-child transmission of HIV-1 using broadly neutralising antibodies (bNAbs). We will conduct phase I/II trials to determine safety and pharmacokinetics of subcutaneous administration of potent and broad anti HIV-1 neutralizing monoclonal antibodies, given to HIV-1 exposed neonates and infants.
Despite considerable progress in reducing HIV-related mortality and increasing the coverage of antiretroviral treatment (ART), HIV continues to be an enormous global health burden in children. Our goal is to define the optimal dose(s), timing, and the ideal combination(s) of broadly neutralising antibodies (bNAbs) to prevent HIV breast milk transmission in high-incidence regions.
We will conduct the first essential steps to test the safety and the pharmacokinetics (PK) parameters of long-acting bNAbs administered to breastfeeding HIV-exposed, uninfected infants (HEU) in South Africa, to identify the optimal dose(s), ideal combination(s) and timing of administration to prevent HIV breast milk transmission, particularly in high-incidence areas.
We will support the clinical trials with exploratory research and answer specific queries with functional data to extrapolate the protective dosing and scheduling as well as with data on the impact of bNAbs administration on the infants immune system and microbiome. The PedMAb trials form an excellent basis for knowledge, technology transfer, quality assurance programs and training between consortium partners. These objectives will ensure that at the collaborators will be prepared to launch an appropriately designed trial to prove efficacy, should we demonstrate safety and adequate PK.
Ospedale San Raffaele SRL, Milan, Italy
South African Medical Research Council (SAMRC), South Africa
University of the Witwatersrand, Johannesburg, South Africa
Institut Immunologie, inflammation, infectiologie et microbiologie (I3M) Inserm, Montpellier, France
University of Bergen, Bergen, Norway