Helen McShane and colleagues reply to Deborah CohenBMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k236 (Published 26 January 2018) Cite this as: BMJ 2018;360:k236
- Helen McShane, deputy head of Nuffield department of medicine1,
- Adrian Hill, director1,
- Mark Hatherill, director2,
- Michele Tameris, clinical researcher2,
- Jacqui Shea, chief executive officer3,
- Ann Ginsberg, chief medical officer3
- 1The Jenner Institute, University of Oxford, Old Road Campus Research Building, Oxford OX3 7DQ, UK
- 2South African Tuberculosis Vaccine Initiative (SATVI), Wernher and Beit South Building, Room S2.01, University of Cape Town, Anzio Road, OBSERVATORY, 7925 Cape Town, South Africa
- 3Aeras, 1405 Research Boulevard #300, Rockville, MD 20850, USA
Cohen questions the justification for a large efficacy trial of the novel tuberculosis (TB) vaccine MVA85A in South African infants.12 This trial confirmed that MVA85A was safe and provided valuable understanding of the TB vaccine.3 These trial results were published within 10 working days of our first seeing the data.24 We strongly agree with calls for rigor in conducting, and openness in reporting, preclinical studies, but we are confident that moving forward with this efficacy trial was justified.
Cohen’s article fails to distinguish between a lengthy academic disagreement and scientific misconduct. Buried within the article are three key points.
Firstly, none of the 14 trials of MVA85A in over 400 humans (the target species) before the infant efficacy trial showed a safety signal. When the University of Cape Town human research ethics committee reviewed the patient information …