Page 179 - SAMRC Annual Report 2024-2025

PERFORMANCE INFORMATION

Managing Vaccine Clinical Trials design with a multi-country discovery medicine
clinical trial platform and laboratory research
VC102 infrastructure.
The SAMRC was the sponsor for the VC102- Phase
1, Open-Label, Dose-Escalation Study to Evaluate During 2024 the programme supported HIV
the Safety and Immunogenicity of a Two-Dose vaccine development efforts at Wits and UCT and
Regimen of VXCO-100, a Spike-Functionalized technology transfer activities at the Joint Clinical
Ferritin Nanoparticle Vaccine Targeting COVID-19, Research Centre and Makerere University Walter
Co-formulated with Aluminum Hydroxide Adjuvant, Reed Project, an extensive community engagement
in Adults in the Republic of South Africa. Vaccine programme, the development of laboratory
Company Inc. (VaxCo), a biotechnology company capacity and preparations for the first clinical
based in the USA is the funder and provider of the study, BRILLIANT-001. The latter included a series
VXCO-100 vaccine. The South African National of site assessments conducted by the Hutchinson
Department of Health donated 240 doses of Pfizer- Centre Research Institute of South Africa with the
Biontech mRNA vaccine to serve as a comparator in programme leadership to assess the facilities,
the VC102 study. research operations, clinical safety processes,
pharmacy operations, community engagement
In 2024, the study completed enrolment and follow and laboratory operations of each clinical research
up of 130 participants at 2 sites in South Africa, the site and to establish their readiness to conduct
Perinatal HIV Research Unit of the University of the phase 1 HIV vaccine clinical trials in compliance
Witwatersrand and the SAMRC Botha’s Hill CRS. with industry best practices, Good Clinical Practice
T cell immunogenicity testing was completed by (GCP) and Good Clinical Laboratory Practice (GCLP)
Prof Wendy Burgers at UCT and antibody testing standards. Using information gathered from the site
was completed by Prof Penny Moore at the NICD/ assessments, 4 sites were selected to participate
Wits. Database lock concluded in September in the BRILLIANT-001 study, which was set to test
2024. The GIPD team was responsible for overall vaccines and adjuvants supplied by the International
project and fund management of the R30 million AIDS Vaccine Initiative (IAVI), Access to Advanced
programme. Final disbursements to all sub awardees Health Institute (AAHI), Fred Hutchinson Cancer
were concluded in March 2025. The Final Study Research Centre (FHCRC) and Polymun Scientific.
Report (CSR), Development Safety Update Report The protocol received SAHPRA approval and was
(DSUR) and study progress report were submitted registered on the South African National Clinical
to SAHPRA in March 2025, and the results will be Trial Registry (SANCTR) and the Pan African Clinical
published in due course. Trials Registry (PACTR). The study preparations
were completed, and study activation was planned
BRILLIANT Consortium for the 27 January 2025. However, shortly after the
The BRILLIANT (BRinging Innovation to cLinical and 2nd BRILLIANT Consortium meeting in Zanzibar
Laboratory research to end HIV In Africa through New on 20-23 January 2025, the team received notice
vaccine Technology) Programme was a Cooperative to suspend the programme and, subsequently in
Agreement with the US Agency for International February 2025 notice of termination of the award.
Development (USAID) initiated in September The ELMA Relief Foundation has provided relief
2023. The consortium was led predominantly by funding to continue the vaccine development
African women scientists from Kenya, Mozambique, efforts for a 6-month interim period following
Nigeria, South Africa, Tanzania, Uganda, Zambia which additional funds will need to be secured to
and Zimbabwe. The SAMRC was the lead institution continue this critical programme.
and GIPD managed all 17 of the sub-awards during
the first 18 months of the programme. The overall SAMRC-IVI-BIOVAC Collaboration
objective of the BRILLIANT consortium was to The SAMRC, in collaboration with the International
develop and evaluate HIV vaccine candidates Vaccine Institute (IVI), Korea, and the Biovac Institute,
emanating from Africa. The Consortium aimed to South Africa are collaborating on a Phase I/III,
conduct both “First-in-Africa” clinical development Multicentre, Observer-Blinded, Randomized, Active
with existing immunogens and adjuvants, as well as Controlled Trial to Evaluate Immune Non-Inferiority,
“First-in-Human” HIV vaccine discovery medicine Safety and Lot-to-Lot Consistency of BIOVAC
studies of novel immunogens. It planned to move Oral Cholera Vaccine to Euvichol-Plus® in 1 to 45
the regional and global HIV vaccine field forward years old Healthy Participants. The team secured
by rapidly evaluating and optimising immunogen a R75 million grant from the ELMA Vaccines and

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