Phase I study to determine Safety and Pharmacokinetics of subcutaneous administration of potent and broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs), given to HIV-1 exposed and uninfected (HEU) neonates and infants (PedMAb1)
PedMAb1 is being conducted as a partnership between the SAMRC, IRCCS Ospedale San Raffaele, Milan, Italy, University of Montpellier, France, Wits Health Consortium and University of Bergen, Norway, with funding from EDCTP and the SAMRC
Read MoreTo evaluate the safety (Adverse Events = AE)
until day 28 after a single subcutaneous (SC) administration of one bNAb, tested at increasing doses within 96 hours of birth, in breastfeeding HIV exposed uninfected (HEU) neonates (arms 1 through 5)
until day 28 after two single SC administration of two bNAbs, tested at increasing doses within 96 hours of birth, in breastfeeding HEU neonates (arm 6)
until day 28 after two single SC administrations of two bNAbs, within 96 hours of birth and repeated at 3 months in breastfeeding HEU neonates (arm 6b)
Read MorePedMAb logo designed by Sashkia Balla
Paintings at the PedMAb1 Chatsworth CRS were designed and painted by Siyethemba Ngubane
If you have questions about this study, please contact the PedMAb1 study team