Oxford TB vaccine study calls into question selective use of animal data

In July 2009, researchers began a clinical trial in infants in South Africa, testing the newest hope for an improved vaccine against tuberculosis.1 Nearly 2800 infants took part. Their parents consented on the basis of information that included the statement that the trial vaccine, MVA85A, “has been tested in animals and was shown to be safe and effective.”

Similar statements had been used to obtain funding and ethical and regulatory approval for the trial. In one funding application, for example, the researchers said that the MVA85A booster had been shown to be more protective than BCG alone in four animal models.

Information given to ethics committees, regulators, and trial investigators said that protective efficacy studies had been carried out in four animal models—mice, guinea pigs, cattle, and monkeys. They reported “evidence of protection” against Mycobacterium tuberculosis when MVA85A was given as a booster to BCG.

However, an investigation by The BMJ has unearthed concerns about how the researchers, from Oxford University, used the results of animal studies selectively to gain funding and approval for human trials, publicly relying on claims that animal studies had shown the new vaccine to be protective while privately playing down or dismissing unsupportive experiments as “failed” or irrelevant. Disappointment at the apparent failure of animal models to predict the outcome of human trials has, in turn, led major funders of TB research to rethink their funding priorities, with allegations that this has slowed progress in the entire field.

The investigation asks whether the parents of babies included in the South African trial were misled …