Sisonke phase 3B open-label study: Lessons learnt for national and global vaccination scale-up during epidemics
Authors:   South African Medical Research Council, South Africa, Goga A E ,   Department of Paediatrics and Child Health, School of Medicine, Faculty of Health Sciences, University of Pretoria, South Africa, Bekker L-G ,   Desmond Tutu HIV Centre, Faculty of Health Sciences, University of Cape Town, South Africa, Garrett N ,   Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa; School of Nursing and Public Health, Discipline of Public Health Medicine, University of KwaZulu-Natal, Durban, South Africa, Takuva S ,   Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; School of Health Systems and Public Health, Faculty of Health Sciences, University of Pretoria, South Africa, Sanne I ,   Right to Care, Johannesburg, South Africa, Odhiambo J ,   Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA, Mayat F ,   Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa, Fairall L ,   Desmond Tutu HIV Centre, Faculty of Health Sciences, University of Cape Town, South Africa; King’s Global Health Institute, King’s College London, UK, Brey Z ,   Bill and Melinda Gates Foundation, Johannesburg, South Africa, Bamford L ,   National Department of Health, Pretoria, South Africa, Tanna G ,   National Department of Health, Pretoria, South Africa, Gray G ,   South African Medical Research Council, South Africa
Published: June 2022

Sisonke is a multicentre, open-label, single-arm phase 3B vaccine implementation study of healthcare workers (HCWs) in South Africa, with prospective surveillance for 2 years. The primary endpoint is the rate of severe COVID‑19, including hospitalisations and deaths. The Sisonke study enrolled and vaccinated participants nationally at potential vaccination roll-out sites between 17 February and 26 May 2021. After May 2021, additional HCWs were vaccinated as part of a sub-study at selected clinical research sites. We discuss 10 lessons learnt to strengthen national and global vaccination strategies:(i) consistently advocate for vaccination to reduce public hesitancy; (ii) an electronic vaccination data system (EVDS) is critical; (iii) facilitate access to a choice of vaccination sites, such as religious and community centres, schools, shopping malls and drive-through centres; (iv) let digitally literate people help elderly and marginalised people to register for vaccination; (v) develop clear ‘how to’ guides for vaccine storage, pharmacy staff and vaccinators; (vi) leverage instant messaging platforms, such as WhatsApp, for quick communication among staff at vaccination centres; (vii) safety is paramount – rapid health assessments are needed at vaccination centres to identify people at high risk of serious adverse events, including anaphylaxis or thrombosis with thrombocytopenia syndrome. Be transparent about adverse events and contextualise vaccination benefits, while acknowledging the small risks; (viii) provide real-time, responsive support to vaccinees post vaccination and implement an accessible national vaccine adverse events surveillance system; (ix) develop efficient systems to monitor and investigate COVID‑19 breakthrough infections; and (x) flexibility and teamwork are essential in vaccination centres across national, provincial and district levels and between public and private sectors.