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Investigation
Oxford TB vaccine study calls into question selective use of animal data
BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.j5845 (Published 10 January 2018) Cite this as: BMJ 2018;360:j5845
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Rapid Response:
Re: Did MVA85A harm any South African infants?
In reply to the letter from Dr. Cunningham, we provide the following safety data from the MVA85A infant efficacy trial, which were posted on clinicaltrials.gov in 2013 when the trial was published:
The seven (1%) deaths in the vaccine group included two from kwashiorkor, two from non-tuberculous meningitis, one from gastroenteritis, one from asphyxia due to drowning, and one from sudden death; and the four (<1%) in the placebo group included two from gastro enteritis, one from encephalitis, and one from a lower-respiratory-tract infection (Tameris M et al, The Lancet 2013). These death rates were not significantly different and reflect the known infant mortality in this setting. Of the two cases of tuberculous meningitis, one was in the placebo group and the other, which was subsequently reclassified as viral meningitis, was in the MVA85A group.
Helen McShane, The Jenner Institute, University of Oxford
Adrian Hill, The Jenner Institute, University of Oxford
Mark Hatherill, South African Tuberculosis Vaccine Initiative, University of Cape Town
Michele Tameris, South African Tuberculosis Vaccine Initiative, University of Cape Town
Jacqui Shea, Aeras
Ann Ginsberg, Aeras
Competing interests: Helen McShane: I am supported by a diverse group of funders, including the Wellcome Trust, The Bill and Melinda Gates Foundation, Aeras and the European Commission, to develop new TB vaccines. MVA85A was developed in my laboratory. Adrian Hill: I am Director of the Jenner Institute, where MVA85A was developed, and have received grant income from a large number of funders for vaccine development, especially against malaria. I am a co-inventor of several vaccine technologies licensed through Oxford University Innovations. Mark Hatherill: I have received support through institutional grants to the University of Cape Town from multiple funders including Aeras and Wellcome Trust for clinical trials of several TB vaccine candidates including MVA85A. Michele Tameris: I have worked on multiple TB vaccine projects funded by Aeras and Wellcome Trust including MVA85A projects. In addition I have previously received two Wellcome Trust International Engagement grants. Jacqui Shea: I was the general manager of the Oxford Emergent TB Consortium, the commercial licensor of the MVA858A vaccine and part funder of the MVA85A trial. I am currently CEO of Aeras, one of the funders and sponsor of the MVA85A trial. Ann Ginsberg: I am currently the Chief Medical Officer for Aeras. Aeras was one of the funders and sponsor of the MVA85A trial.