Durban AIDS vaccine trial site to close down

[This report does not necessarily reflect the views of the United Nations]

DURBAN- - Although some researchers have attributed the closure of the trial site run by the South African Medical Research Council (MRC) to the low numbers of volunteers, the MRC stressed the decision had nothing to do with recruitment of volunteers or the quality of research.

Dr Andrew Robinson, head of the MRC HIV vaccine unit, told PlusNews that the trial site's funding cycle had simply come to an end after five years, and was possibly not being renewed because its core funder, the US-based National Institutes of Health (NIH), preferred to invest in larger, multipurpose vaccine research sites.

According to Robinson, NIH has closed down a number of smaller AIDS vaccine trial units around the world, including one located in Botswana.

The Durban site had been suitable for the first two phases of AIDS vaccine trials, which required small numbers of volunteers, but Robinson noted that it would not have managed the later trial stage.

There are three phases in human clinical trials: phase one involves 20 to 60 healthy, uninfected volunteers at low risk of HIV infection, and tests for safety; phase two is aimed at maintaining the safety level of the vaccine, finding the best dosage and the best way to administer the vaccine; the third phase requires thousands of participants to determine whether the vaccine prevents HIV infection.

Robinson admitted that recruiting trial participants had been "a challenge" - people were reluctant to participate due to the stigma surrounding HIV/AIDS, while others did not match the stringent eligibility criteria.

The MRC had recruited 18 volunteers, and about 40 eligible participants were on the waiting list, said Robinson. Although this fulfilled the minimum requirement for Phase I trials, a low number of suitable volunteers could easily put the research at risk if trial participants dropped out of the tests.

The site will close in mid-2006 after the Phase I safety trials have been completed.

Dr Eftyhia Vardas, director of the HIV/AIDS vaccine division at Chris Hani Baragwanath Hospital in Soweto near Johannesburg - the country's other vaccine trial site - suspected that poor enrolment numbers at the Durban site were the reason for phasing out the study.

"The MRC missed out on the first vital step: to thoroughly inform the communities they worked with about the trials and, hence, didn't manage to find a sufficient number of volunteers," she told PlusNews.

The site had sometimes even "borrowed" volunteers from Soweto to fulfil minimum trial participant requirements, Vardas said.

Robinson denied rumours that one of the reasons for phasing out the MRC study had been protocol violation. "At no stage was any trial participant put at risk," he told PlusNews, adding that the "quality of research is not the reason for the closure."

He noted that the MRC vaccine research unit had been audited by independent medical groups on a regular basis, and although inspectors had found minor administrative irregularities, these had been corrected.

NIH also confirmed that no protocol violation warranting closure of the site had been reported.

Closing the Durban site should not be seen as a setback to South African AIDS vaccine research, said Vardas.

"AIDS vaccine trials will continue in South Africa," she added, confirming that the Soweto research site had recently secured a second round of funding from both NIH and the SA AIDS Vaccine Initiative (SAAVI), the umbrella organisation coordinating local HIV vaccine trials.

Unlike the MRC's trial in Durban, the Soweto site "already has substantial capacity in place for future larger trials," Dr Jorge Flores, head of the NIH's Vaccine and Prevention Research Programme at the National Institute of Allergy and Infections Diseases (NIAID), told PlusNews.

The Soweto site is conducting Phase I as well as Phase II trials.

Local researchers injected the first test vaccines in November 2003, making South Africa the first country in the world to start AIDS vaccine trials for HIV subtype C, the most common strain of HIV in southern Africa.

Two additional trial sites are about to open in South Africa: one located in Cape Town, the other in Orkney in North West province. Both sites started educating the surrounding communities about the AIDS vaccine trials last year and will begin research in the next few months, according to SAAVI spokeswoman Michelle Galloway.

Regarding the phasing out of the MRC trial site, Galloway said it was "normal procedure for research units to compete for international funding", with some funding applications being successful and others not.