Researchers in South Africa will begin Monday to inoculate thousands of volunteers in the latest — and, some say, most promising — effort to develop a vaccine that prevents HIV/AIDS.
Should the vaccine prove to be 50-to-60 percent effective, experts say that would be enough for drug makers to begin licensing negotiations with the South African government.
Such a rate is below the acceptable margin for other vaccines, but would still make this one worth producing in South Africa — given that nearly 20 percent of South Africans are infected. The virus infects more than 2 million people globally and kills more than 1 million every year.
From Washington Post. Story by Ryan Lenora Brown and Lenny Bernstein.
Researchers were encouraged four years ago when a test of a vaccine on 16,000 people in Thailand turned up a previously unknown vulnerability in the resilient pathogen.
The vaccine was only 31 percent effective and wore off over time, so it could not be approved for use in a general population. But the study’s results allowed scientists to exploit the chink in HIV’s armor, reformulate the drug and bring it back for another clinical trial.
Now all eyes are on South Africa, where researchers will begin inoculating thousands of volunteers Monday in the latest — and, some say, most promising — effort to develop a vaccine that prevents the disease. It is only the seventh full-scale human trial for a virus that infects more than 2 million people and kills more than 1 million every year.
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“If this study shows efficacy . . . this would be a tectonic, historic event for HIV,” said Nelson L. Michael, director of the U.S. Military HIV Research Program, which led the Thailand study.
Should the vaccine prove to be 50 percent to 60 percent effective, experts say, that would be sufficient for drugmakers Sanofi Pasteur (based in the U.S., it’s the largest company in the world devoted entirely to vaccines) and GSK to begin licensing negotiations with the South African government. While such a rate is well below the acceptable margin for other vaccines, it would still make this one worth producing here — given that nearly 1 in 5 people are infected.
(Based in the France, Sanofi Pasteur is the largest company in the world devoted entirely to vaccines. U.K.-based GlaxoSmithKline/GSK is the world’s sixth largest pharmaceutical company.)
An agent that works in South Africa could be adjusted later for use against viral subtypes that circulate elsewhere, including in the United States.
“Given that right now we have nothing, we’d be happy if this vaccine were even 45 or 50 percent effective,” said Gita Ramjee, director of the HIV Prevention Research Unit at the Medical Research Council in Durban, which is running two of the 15 trial sites. “Even a modestly effective vaccine like that would have a huge impact here.”
About 5,400 people who are HIV-negative, sexually active and between the ages of 18 and 35 are being recruited. Each will receive five injections over the course of the year and then be monitored for two years.
Half the volunteers will receive a placebo so that researchers can measure the vaccine’s efficacy. But that hasn’t deterred South Africans from signing up. Few lives are untouched by the disease.
“I don’t want another generation to go through what I did,” said Thembi Dlamini, 29, who this week was being screened at a clinic for participation in the trial.
Her older sister died of AIDS five years ago in a brutal descent. The only silver lining was its brevity: She was gone in just three months, with a stash of HIV medication in her dresser drawer. Her shame was greater than the fear of wasting away.
Dlamini estimates that half her friends are HIV-positive — hardly an outlandish calculation in a country where about a third of the women in her age group have the virus.
For 18-year-old S’phindile Dlamini, another volunteer, it was a neighbor whom she remembers dying. In their community, people normally pitched in when someone fell ill. But the more brittle this woman grew, the farther away people stayed and the louder they whispered.
Though HIV has faded from the headlines since the development of antiretroviral drugs made the disease manageable, it is still a pandemic. About 36.7 million people worldwide were living with HIV in 2015, including about 2.1 million who were newly infected, according to the Joint United Nations Program on HIV and AIDS. In the United States, the Centers for Disease Control and Prevention says 1.2 million people are infected.
South Africa has more than 7 million people living with the virus. In some parts of the country, such as the northeastern coastal province of KwaZulu-Natal, where Verulam is located, estimates place the number of HIV-positive people at nearly 30 percent.
There is no preventive drug and no cure. Yet this is the first new human HIV vaccine study in about a decade.
Read more at Washington Post.