Page 90 - SAMRC AnnualReport 2025-26

Key Milestones and Achievements Another highlight was HIDRU’s selection to assess
the safety and immunogenicity of a new essential
HIDRU's advanced pioneering work in pMTCT through
the completion of the PedMAb1 trial marked the African oral cholera vaccine through a randomised
first-ever worldwide dose escalation of two broadly controlled trial, providing evidence for a locally
neutralising antibodies (bNAbs) in HIV-exposed significant vaccine candidate.
neonates. Positive findings prompted the launch of
PedMAb1-Ex, a Phase I extension study evaluating
bNAbs in adults and HIV-exposed uninfected
infants. The SAMBULELO Phase II trial is currently
assessing the safety and pharmacokinetics of bNAbs
in HIV-exposed newborns during breastfeeding,
while exploring strategies to reduce viral reservoirs
in infants living with HIV. Complementary qualitative
studies continue to investigate infant feeding options
and maternal multi-morbidity.

The Unit also contributed substantially to the
evaluation of HIV vaccines and pre-exposure
prophylaxis (PrEP) strategies through multiple
Phase I–III randomised trials, including PURPOSE 1,
PrEPVacc, HVTN 139, HVTN 142, DESIIGN001/IAVI
G004, and HPTN 084/VIIV Palisade. The ongoing HIDRU participates in studies assessing
long-acting oral and injectable formulations
MSD EXPRESSIVE study is evaluating a once-monthly aimed at simplifying treatment regimens and
oral PrEP tablet for young women, with the potential improving adherence for lifelong HIV care.
to improve adherence and expand prevention
options. HIDRU’s major contribution to PURPOSE
1 supported the development of Lenacapavir,
anticipated for public sector rollout in 2026.

Research into novel antiretroviral treatment
approaches also continues, with HIDRU participating
in studies assessing long-acting oral and injectable
formulations aimed at simplifying treatment regimens
and improving adherence for lifelong HIV care.
MDR-TB during pregnancy remains a key research
priority. HIDRU scientists oversee the world’s largest
database of pregnant women with drug-resistant
TB, with findings indicating significant adverse infant
outcomes and guiding discussions on improved
treatment strategies for this high-risk group.

The Unit also continued participation in the Gates
MRI CommuniTB Phase III trial evaluating the M72
TB vaccine for TB prevention. Recruitment has been
completed, and final analyses on vaccine efficacy
are awaited. The HVTN 605 study assessing the
MTBVAC vaccine in adults and people living with
HIV was temporarily paused during the transfer of
sponsorship from DAIDS to the Fred Hutchinson
Cancer Center and is expected to reopen in April
2026. Meanwhile, the AfriplexGRT first-in-human
trial is currently enrolling participants to evaluate a SAMRC's Verulam Clinical Research Site staff.
Rooibos-derived intervention for metabolic disease.

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