SAMBULELO, a phase II double blind randomised 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. - Trial PACTR202308483453792

Timeline & Enrollment

Summary

Despite the deployment of lifelong universal triple antiretroviral therapy (ART) in HIV-infected pregnant and breastfeeding mothers (Option B+), since 2013, it is estimated that 180,000 new paediatric HIV infections occurred during the year 2017 alone (UNAIDS 2018). Understanding how best to manage these infections and how to eliminate paediatric HIV reservoirs, to achieve paediatric functional HIV cure is critical (Technau 2017and 2018). These residual transmissions, as high as 12-15% at 18 months are still common in many settings. Itis estimated that at least half of this residual transmission is attributable to breastfeeding (BF) as a result of lateinitiation of maternal ART during pregnancy or BF, lack of maternal adherence to ART, incomplete PMTCTcascade (no HIV testing, no ART initiation), cell-associated HIV transmission by BF [12 months MTCT rate2.4% (Rollins 2012) or 2.9% (Bispo, 2017)] or acquisition of maternal HIV infection during pregnancy or breastfeeding (Pintye, 2018, Dinh 2015). Consequently, complementary interventions are needed to attain the paediatric HIV elimination target, and possibly also to optimise management of HIV-infected children. Strategies such as infant PrEP (Van de Perre, 2017) and infant passive immune prophylaxis (Pegu, 2017) maybe particularly useful as these do not rely solely on maternal adequate adherence or response to ART.Primary objectives:1. To evaluate the safety up to age 12 weeks of a single subcutaneous (SC) injection of VRC07-523LS, administered within 72 hours of birth in HIV exposed uninfected (HEU) breastfeeding infants (Group 1) and newly diagnosed HIV-infected breastfeeding infants (Group 3).2. To determine the pharmacokinetics up to age 12 weeks of a single perinatal SC injection of VRC07-523LS, in HEU breastfeeding infants (Group 1) and newly diagnosed HIV-infected breastfeeding infants (Group 3).

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