Controlled Human Infection Challenge Studies:
Lessons from Malaria towards COVID-19
Since severe acute respiratory infections caused by the SARS-CoV-2 virus have first been reported in December 2019, COVID-19 has developed in a pandemic posing a major threat to global public health and to societies worldwide.
According to WHO, major challenges for the current public health response include a lack of safe, effective vaccines and treatments, and gaps in scientific knowledge regarding pathogenesis, immunity and transmission.
As of mid-July 2020, 23 candidate vaccines are in early clinical development, and 140 candidates in preclinical evaluation. Controlled Human Infection Challenge Studies which involve the deliberate infection of healthy volunteers are well established during the clinical development of vaccines for influenza, typhoid, cholera or malaria. Their aim is to accelerate clinical vaccine development by providing (preliminary) estimates of efficacy and safety and to select the most suitable candidates for further development. In addition, such studies have been used to better understand the immune response processes after infection.
These studies must be based on thorough ethical and scientific principles, and must involve careful community engagement. This webinar will describe these principles, outline the risk mitigation steps taken in previous malaria human challenge studies, explore how this might be applied in the context of COVID-19 vaccine development, and address ethical and practical concerns.
Presentations, Reading List and Q&A
"Leveraging Human Infection Studies in Endemic Populations"
by Getnet Yimer
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"Covid-19 Challenge Studies: Practical and Ethical Issues"
by Euzebiusz Jamrozik
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Reading List & Related Links
WHO working group on guidance on human challenge studies for COVID-19 [Link]
Paper by Zeb and Michael on COVID-19 human challenge studies [Link]
Controversial ‘human challenge’ trials for COVID-19 vaccines gain support (Science Magazine)
Tuesday, 1 September 2020
Marco Cavaleri, Head of Office, Anti-infectives and Vaccines, European Medicines Agency (EMA), Amsterdam, The Netherlands
Euzebiusz (Zeb) Jamrozik, Monash Bioethics Centre, Monash University, Melbourne, Australia
Melissa Kapulu, Kenya Medical Research Institute, Nairobi, Kenya
Colin Pillai, CP+ Associates and Pharmacometrics Africa, Basel (Switzerland) and Cape Town (South Africa)
Andrew J Pollard, Professor of Paediatric Infection and Immunity, University of Oxford, Oxford, England
Bernd Rosenkranz, Fundisa African Academy of Medicines Development NPC, Schwielowsee (Germany) and Cape Town (South Africa)
Getnet Yimer, Regional Director for Global One Health Initiative of the Ohio States University in East Africa, Addis Ababa, Ethiopia
Craig R. Rayner, President – Integrated Drug Development, Certara