BCG Vaccine Clinical Trial in response to Covid-19 pandemic
TASK008 – A placebo-controlled adaptive randomized controlled trial
Caption of press photo:
TASK nurse injects the first participant, watched closely by study leader Dr Caryn Upton and Professor Andreas Diacon, founder and CEO of TASK.
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:
TASK is a social enterprise committed to developing, testing and progressing novelty medicines, vaccines and diagnostics in various medical therapeutic areas, most notably in anti-tuberculosis drugs, aimed at improving global health care.
Since its inception in 2005, TASK has grown exponentially and diversified into six distinct independent clinical research sites; a mycobacteriology bio-safety level 3 laboratory; a phase I to II clinical trial hospital with twenty-four beds; two registered dispensing pharmacies; a data management centre; regulatory, quality control and compliance office and a clinical research training academy.
Over the last 15 years, TASK has completed 65 research projects, many of global significance and contributed to progressing the scientific field of TB drug and vaccine development, most notably with early bactericidal activity (EBA) studies and clinical trials that in part led to the registration of Bedaquiline.
Andreas Diacon MD; PhD, is a Professor of Medicine and Principal Specialist in Pulmonology at Stellenbosch University and Tygerberg Academic Hospital, Cape Town, South Africa and is the founder and CEO of TASK.
He received his MD from the University of Zürich, Switzerland, in 1987, specialized in Internal Medicine and Pulmonology, and earned a PhD from Stellenbosch University in 2007. His main research interests now lie in the techniques and clinical methods for the evaluation of novel anti-tuberculosis agents. He is engaged in various research collaborations within South Africa and with the USA and Europe.
Recently Andreas Diacon was named as one of Bill Gates’s Heroes in the Field through his contributions and continuing search for better treatment solutions for tuberculosis.
1. Schaaf HS, Preez K, Kruger M, Solomons R, Taljaard JJ, Rabie H, et al. Bacille Calmette-Guérin ( BCG ) vaccine and the COVID-19 pandemic : responsible stewardship is needed. The Union. 2020;1–6.
2. Miller A, Reandelar MJ, Fasciglione K, Roumenova V, Li Y, Otazu GH. Correlation between universal BCG vaccination policy and reduced morbidity and mortality for COVID-19: an epidemiological study. medRxiv. 2020;1–9.
3. Netea MG, van der Meer JWM. Trained Immunity: An Ancient Way of Remembering. Cell Host Microbe. 2017;21(3):297–300.