South Africa Leading the Way in Medicine Development Through Clinical Trials:
By Nyeleti Bicky Mthombeni
Medical Research conducted in human participants, to answer to a specific medical need.
• Research responsive to the health needs of communities leading to development of
• New treatment or New Medical Device
• Improvement of current treatment
• Knowledge generation
• Compare treatments
• Improve health care of communities
• Participating communities should stand to benefit from the knowledge, practices, or interventions that result from the research
• Research should address local and continental issues and while maintaining global perspectives.
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TASK Covid-19 BCG vaccine trial:
TASK Applied Sciences - Cape Town
Covid-19 BCG vaccine clinical trial has begun here in South Africa, and is a placebo-controlled adaptive randomized controlletrial called: TASK008.
TASK has just injected the first healthcare worker in a clinical study led by Professor Andreas Diacon and Dr Caryn Upton.
The aim of the study is to determine if BCG (re)vaccination reduces the probability of infection with the SARS-CoV-2 virus and/or the severity of symptoms of Covid-19 disease.
SARS-CoV-2 has spread rapidly throughout the world. The pandemic seriously challenges the available hospital capacity in South Africa. Strategies to prevent staff absenteeism in an over-run healthcare system are, therefore, desperately needed to safeguard continuous patient care.
Bacille Calmette-Guérin (BCG) is used as a vaccine against tuberculosis in children, but it also has non-specific protective effects against other respiratory tract infections in children and adults. South Africa does vaccinate all new-borns with BCG. Re-vaccinating adults could help reduce the consequences of this pandemic.
The primary objective of this trial is to find out if BCG (re)vaccination reduces disease severity, hospital admissions and death in frontline workers with direct patient contact during the pandemic phase of COVID-19.
A minimum of five hundred healthcare workers will be invited to participate. After vaccination TASK will follow up regularly with telephonic or electronic interviews to capture events such as SARS-CoV-2 virus infection, respiratory tract infection or hospitalisation. The study team will regularly run statistical tests to see if an advantage of BCG re-vaccination can be shown. There will be an independent committee looking at the results. If there is a robust enough positive signal the results will be made public.
This study is currently funded by TASK and limited to 500 participants. External funding would allow an increase in the number of participants. This would in turn detect a protective effect of BCG (re)vaccination more quickly. Thus we are calling on all appropriate entities, internal sponsors and funders and local government to make further funds available.
For media enquiries or to participate as a sponsor or funder:
Duncan McDonald: duncan@task.org.za
t +27 21 100 3606
To join the study as a participant:
Call or WhatsApp: 079 050 2775
Email: bcg@task.org.za