South Africa launches AIDS vaccine clinical trials

It represented a feat by scientists who overcame skepticism from colleagues and from some political leaders who shocked the world with unscientific pronouncements about the disease.

"It has been a very, very hard journey," lead scientist Professor Anna-Lise Williamson of the University of Cape Town said at Monday's ceremony, attended by American health officials who gave technical help and manufactured the vaccine at the U.S. National Institutes of Health.

Williamson said she sees no choice for South Africa, at the heart of the epidemic, "where we have got the biggest ARV (anti-retroviral) rollout in the world and still hundreds of people are dying every day and getting infected everyday."

Trials to test the safety in humans of the vaccines begin this month on 36 healthy volunteers, Anthony Mbewu, president of South Africa's government-supported Medical Research Council, said in an interview Sunday. Mbewu's respected organization shepherded the project.

A trial of 12 volunteers in Boston began earlier this year.

Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Disease and a leading AIDS researcher, said the South African scientists received more money from his institute's research fund than any others in the world except the U.S.

He called it "the most important AIDS research partnership in the world."

But he warned "There are extraordinary challenges ahead," referring to the years of testing needed now that South Africa has reached the clinical trial stage.

Fauci said scientists do not understand why the search for an AIDS vaccine is so difficult, except that they are trying to do better than nature: "We have to develop a vaccine that does better even than natural protection."

South Africa was the site of the biggest setback to AIDS vaccine research, when the most promising vaccine ever, produced by Merck & Co. and tested here in 2007, found that people who got the vaccine were more likely to contract HIV than those who did not.

During nearly 10 years of denial and neglect, South Africa developed a staggering AIDS crisis. Around 5.2 million South Africans were living with HIV last year - the highest number of any country in the world. Young women are hardest hit, with one-third of those aged 20 to 34 infected with the virus.

In 1999, the ministries of health and of science and technology founded the vaccine initiative and poured 250 million rand ($31.2 million today) into it over eight years.

Some 250 scientists and technicians worked on the project, along the way gaining scores of doctorates and producing work for professional publications as well as a model for continued biotechnology development in South Africa.

The government decided it was important to develop a vaccine specifically for the HIV subtype C strain that is prevalent in southern Africa "and to ensure that once developed, it would be available at an affordable price," Mbewu said.

He spoke on the sidelines of an international AIDS conference where Vice President Kgalema Motlanthe emphasized Sunday night the clinical trials are being held "under strict ethical rules."

The first trial may have been started in the U.S. to allay any criticism that the U.S. was collaborating in an AIDS vaccine that would use Africans as guinea pigs.

The field of AIDS vaccine research is so filled with disappointments some activists are questioning the wisdom of continuing such expensive investments, saying the money might be better spent on prevention and education.

Mbewu said the crisis in South Africa, where "we have the biggest problem" in the world, more than justifies the expenditure.

AIDS strikes men and women alike in Africa, where the epidemic is fueled by the many people who have sex with several people at the same time, as opposed to the serial monogamy usually practiced in the West.

In the 1990s, South Africa's then-President Thabo Mbeki denied the link between HIV and AIDS, and his health minister, Manto Tshabalala-Msimang, mistrusted conventional anti-AIDS drugs and made the country a laughing stock trying to promote beets and lemon as AIDS remedies.

Williamson, a virologist, said the scientists had to fight continual controversy, including international organizations trying to stop the state utility Eskom from funding the project. Eskom gave "huge amounts," regardless.

"International organizations told Eskom that this was a terrible waste of money, that putting money into South African scientists was like backing the cart horse when they need to be backing the race horse."

Even her research director told her she was wasting her time.

"Most of them just made us more determined to prove them wrong," Williamson said.

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