Page 13 - AnnualReport2022-23

PAR T A: GENERAL INFORMATION

the Johnson and Johnson Ad26.COV2.S vaccine. SAMRC, and the Africa Centres for Disease Control
The study enrolled >12,000 participants between and Prevention (Africa CDC). The SAMRC’s role in
May and November 2022, with a further 200 enrolled the hub is to drive the R&D programme which is
in a more detailed immunogenicity sub-study. aimed at the research, development and testing of
Results from this study are due in 2023/24. mRNA vaccine candidates for COVID-19 and other

The SAMRC has also supported the BaSiS Study at priority diseases to ensure a pipeline of products
Wits RHI Shandukani, which is a phase II randomised for manufacture by the spokes in South Africa
open label trial of full and half dose J&J Ad26. and other low- and middle-income countries. The
CoV2.S and Pfizer BNT162b2 booster vaccinations SAMRC is also the clinical trial partner for the mRNA
after receiving the J&J Ad26.CoV2.S prime vaccine Technology Transfer Hub.
through the SISONKE phase IIIB implementation
study. The aim of this study is to evaluate The SAMRC has convened a consortium of
immunogenicity (humoral and cellular) and safety development partners known as the South African
of a 1:4 randomization of either homologous J&J mRNA Vaccine Consortium (SAMVAC), comprising
Ad26.COV2.S or heterologous Pfizer BNT162b2, of the University of the Witwatersrand, the University
at full or half dose booster vaccinations, given at of Cape Town, the African Health Research Institute,
least 4 months after a single J&J Ad26.COV2.S the University of Stellenbosch, North-West University,
prime at 4 clinical trial sites. The study enrolled 291 the National Institute for Communicable Diseases,
participants by 31 August 2022, which represents the SAMRC and Afrigen Biologics. SAMVAC is
97% of the enrolment target of 300 participants. leveraging off existing research expertise and prior
A high number of the population enrolled (39.9%) SAMRC and DSI investments to develop a portfolio
are people living with HIV (PLHV). Data analysis for of (m)RNA vaccine candidates by Africa for Africa.
the study is ongoing. The BaSIS study was funded It is also leveraging off the surveillance programme
from a National Treasury allocation through the
National Department of Health for a Vaccine Rollout of the Africa CDC, of which the NGS-SA are
Research Programme. The PI has raised additional leading partners, to ensure the most appropriate
funding from the Bill & Melinda Gates Foundation to immunogens are identified for vaccine development.
extend the study follow-up time to 24 months post The SAMVAC Programme commenced in January
enrolment. This will enable the collection of data on 2022, focusing initially on vaccine candidates for
longer term immunity to prime/boost vaccination, African COVID-19 variants and rapidly expanding to
evaluation of the memory response in participants include research and development on TB and HIV
and tracking of long-term effects of comorbidities vaccine candidates. The early development work is
such as HIV, TB and diabetes. underway at the University of Witwatersrand (Prof
Arbuthnot and Prof de Koning) with the development
The mRNA Technology Transfer Hub was
established in 2021 with the objective of building of ionisable lipids and mRNA-encoding plasmids
capacity in low- and middle-income countries that include the Omicron spike variant of concern.
to produce mRNA vaccines through a centre of The immunogen components of the TB and HIV
excellence and training. The hub is intended to drive projects are led by Dr Musvosvi and Prof Scriba
greater and more diversified vaccines manufacturing and Prof Chapman, respectively, from the University
capability, strengthen African regional health of Cape Town. The programme will also see the
security and respond more equitably to the current technology transfer of a hamster challenge model
COVID-19 pandemic and future pandemics. The from the University of Marseille in France to UCT.
consortium partners include the World Health
Organization (WHO), Medicines Patent Pool (MPP), SAMVAC is funded by the SAMRC, the DSI, ELMA
Afrigen Biologics (Pty) Limited, the Biologicals and Vaccines and Immunization Foundation and funds
Vaccines Institute of Southern Africa (Biovac), the raised by MPP and the WHO.

SAMRC ANNUAL REPOR T 2022-23 11