CAPE TOWN, South Africa – South Africa launched clinical trials of the first AIDS vaccine created by a developing country Monday, as its own scientists overcame deep skepticism from political leaders who had shocked the world with their unscientific pronouncements about the disease.
The new vaccine targets the specific HIV strain that has ravaged South Africa's people and produced the worst AIDS epidemic in the world.
"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.
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.
Williamson said she sees no choice for South Africa, at the heart of the epidemic, but to press ahead with trials to test the safety of the vaccine in humans.
"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," she said.
At a ceremony in Cape Town's Crossroads shantytown, one of the first of 36 healthy volunteers was injected Monday before officials and journalists.
The same vaccine is being tested at a trial of 12 volunteers in Boston that began earlier this year, said Anthony Mbewu, president of South Africa's government-supported Medical Research Council that shepherded the project.
The trial may have been started in the U.S. to allay any criticism that the United States was collaborating in an AIDS vaccine that would use Africans as guinea pigs.
"It is being very well tolerated, no adverse events, so it is going very well," Williamson said.
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.
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.
Some 250 scientists and technicians worked on the latest vaccine project, along the way gaining scores of doctorates and producing work for professional publications as well as a model for biotechnology development in South Africa.
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."
At an international AIDS conference in Cape Town, Vice President Kgalema Motlanthe emphasized Sunday night that the clinical trials were being held "under strict ethical rules."
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.
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 constant controversy, including international organizations that tried to stop the state utility Eskom from funding the project. Eskom gave "huge amounts," regardless, she said.
"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," she said.
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.