Row over Oxford TB vaccine trial on SA babies

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Oxford University is embroiled in an ethics row after scientists were accused of questionable conduct over a controversial trial of a new vaccine on South African babies.

The Daily Telegraph reports that Professor Peter Beverley, a former senior academic at the university, complained that scientists planned to test a new tuberculosis vaccine on more than a thousand infants without sharing data suggesting that monkeys given the immunisation had appeared to “die rapidly”.

“Certainly here in this experiment there was no evidence whatsoever that this is an effective booster vaccine,” Beverley said. He claimed the information was not given to regulators when an application to do the trial was initially submitted.

The report says in the monkey study, five out of six of the animals infected with TB who were given the experimental vaccine had become “very unwell” and had to be put down. An information sheet given to families in South Africa participating in the trial said the vaccine had been tested on animals and humans and was “safe and effective” in animals.

Professor Jimmy Volmink, dean of the faculty of medicine and health sciences at Stellenbosch University, is quoted in the report as saying that the information sheet did not appear to reflect the evidence from the monkey study, which was “not right”. He said people affected by tuberculosis were often poor and “not very highly educated”, making it particularly important that they were given “clear, understandable information.”

The report says almost 1,500 babies in South Africa received the new jab and parents were paid in the region of £10 for taking part. But the South African regulator which approved the trial has now admitted that the information sheet given to parents “could be construed as misleading”, raising questions about whether families were sufficiently informed.

The scientists at Oxford who carried out the trial maintain that the jab was safe for children and that their experiment was approved by several regulators in advance. They said they followed the infants’ development for two years after the immunisation was given – a time period approved by the regulators.

The report says the monkey study that concerned Beverley began in November 2006 and the application to test the vaccine in the Western Cape was submitted 18 months later. Around this time, Beverley said he heard that the animals in a study had to be euthanized “rather rapidly”.

All the monkeys were infected with TB, but one group was given the widely used BCG jab, a second was given no immunisation and a third was given BCG plus new vaccine.
The baby trial began in July 2009 and almost half of the 2,800 infants taking part were given the new jab.

In 2013, the outcome of the trial on the infants was announced and concluded that the new vaccine offered no increased protection.

The report says Beverley, a principal research fellow at the University of Oxford until 2010, complained formally to the university. An inquiry was launched and concluded that although there had been no wrongdoing, it “would have been good practice for the potentially adverse reaction observed in the monkey experiment to be reported to the authorities in a more timely fashion.”

Professor Helen McShane, one of the lead scientists who developed the new vaccine, has said that the purpose of the monkey study was to “test the aerosol delivery” to the animals, not to “yield safety information”. She said it was a “failed experiment” because “there was no difference” between the groups.

McShane is quoted in the report as saying that there was no delay in providing data from the monkey experiment to regulators. She said she did not think that families in South Africa were exploited and that regulators had signed off the information sheet that was given to parents. She added that the monkey trial contained a “limited” number of animals and Beverley was “disgruntled”.

South African Medicines Control Council, which was one of the regulators who approved the trial, said in the report that a “large body of data” – apart from the monkey experiment and which included previous human trials – was considered as part of the approval process. They also said that the monkey experiment was “not a trial of the vaccine in monkeys” and that “there was no suggestion that the vaccine was unsafe in the monkeys or that it had caused disease or death”

However, according to the report, when asked about the information sheet that was given to parents, the regulator said, “In retrospect the information on efficacy achieved in the animal studies could be construed as misleading”, although the “evidence of safety in the previous human studies was fairly reported”.

http://www.telegraph.co.uk/news/2017/09/03/oxford-university-scientists-gave-babies-trial-tb-vaccine-did/


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