The AIDS vaccine trial site in Durban is being phased out, despite the fact that KwaZulu-Natal is the centre of the country’s HIV/AIDS epidemic.
This follows the decision of the trial’s funder, the US-based National Institutes of Health (NIH), not to support the site further when its grant ends early next year.
The other South African vaccine trial site in Soweto has been given a year’s extension of its grant to complete its trial and will then have to ‘recompete to be a site in the new funding cycle,’ said the site’s Dr Glenda Gray.
According to informed sources involved in the trial process, there had been a number of ‘protocol violations’ at the Durban site, which is at the Medical Research Council’s (MRC) Overport offices.
In addition, there were concerns that the site was based in a suburb and not a community where it would be easy to recruit large numbers of volunteers needed for Phase II and III trials, as well as the fact that the site’s principal investigator was not based permanently in Durban.
However, the site’s principal investigator, Dr Andrew Robinson, acknowledged that while there had been ‘findings’ related to trial, none of these had been serious.
‘There is not a trial site in the world that does not have ‘protocol violations’, a rather misleading term used to cover a range of findings including minor administrative problems and major findings,’ said Robinson.
‘We have dealt with every so-called ‘protocol violation’ raised by the quarterly monitoring process. At no stage whatsoever was the safety or integrity of any of the trial participants at risk.’
Robinson added that it was ‘very disappointing that the NIH had taken the decision unilaterally without giving us an opportunity to respond to any problems they might have. But this appears to be part of their overall strat plan linked to funding press and the growing realisation that V longer than anticipated
He also pointed out that he was in Durban two days’ a week and always present at every vaccination and critical check-ups of the volunteers, and that the NIH had been fully aware of where the site was placed when it had approved the grant.
Dr Jorge Flores, of the Vaccine and Prevention Research Programme at the National Institute of Allergy and Infections Diseases (NIAID) of the NIH, said the decision to grant extensions to trial sites was based on ‘the number of volunteers in ongoing studies and on the imminent participation of the sites in newly planned trials’.
‘Few volunteers were enrolled at the Durban site, and those volunteers were at the end of their participation in the trial. In addition, no new trials in which the Durban site could have been included were ready to start. Based on these criteria, the Durban site was not extended,’ said Flores.
Flores added that the decision had not been influenced by protocol violations.
‘Proper vaccination procedures and follow up of volunteers took place in the single trial in which the Durban site participated, and the data from their participation will be extremely useful for the analysis of the study,’ said Flores.
The site will close in mid-2006 after the two Phase I safety trial of the two candidate vaccines, involving 18 volunteers, has been completed.
‘A lot of things still have to be worked out but we are committed to ensuring that the trial volunteers will be properly cared for after the closure,’ said Robinson.
Cathy Slack of the HIV/AIDS Vaccines Ethics Group (HAVEG) at the University of KwaZulu-Natal, said that the site’s closure was particularly disappointing for the province ‘but finding an AIDS vaccine is a long, bitterly difficult process’.
‘It is critical that the welfare of the trial participants is not jeopardised,’ said Slack. ‘It is also important that communities involved in vaccine trials understand how the trials are funded to prepare them for such disappointments.’
However, Durban may have another chance of hosting a vaccine trial. UKZN’s Professor Salim Abdool Karim, director of the Centre for the AIDS Programme of Research in South Africa (Caprisa), confirmed that his organisation has applied to the NIH to be a vaccine site.
Numerous attempts to get comment on the Durban site closure from MRC President Professor Tony MBewu failed. MBewu has since left the country and will only be available in two weeks’ time, according to his secretary.
The SA AIDS Vaccine Initiative (SAAVI), the umbrella organisation co-ordinating the country’s AIDS vaccine trials, said that the decision to close the Durban site was taken by the MRC.
‘Durban is an MRC site, and it’s an MRC decision,’ said SAAVI spokesperson Michele Galloway. SAAVI acting co-director Elise Levendal also refused to comment on the Durban site’s closure.
South Africa became the first country in the world to start trials of a vaccine aimed at stopping HIV subtype C, the train of HIV most common in southern Africa. Volunteers started testing the safety of the candidate vaccine in both Durban and Soweto in November 2003.
E-mail Kerry Cullinan