Durban - KwaZulu-Natal, because of its highest burden of HIV, will be one of the 15 sites in South Africa where the largest HIV vaccine clinical trial in seven years will take place.
About 5 400 people will take part in the trials to study whether an “experimental” HIV vaccine is safe, tolerable and effective at preventing HIV infection among South African adults. The KZN testing sites are in Isipingo, Verulam, Durban central and Ladysmith.
Announcing the study, the US National Institute of Allergy and Infectious Diseases (NIAID) said participants would be HIV-negative men and women aged between 18 and 35 years “who are at risk of HIV infection”.
They will be recruited through community outreach programmes and reimbursed for their time and participation. Participants will receive a total of five injections over a year, and will then be followed for another one or two years.
The injections will be administered from the start, then at one month, three, six and 12 months. The participants will then be monitored every three months.
The trial is expected to start in November and continue for five years.
Dr Glenda Gray, president and chief executive of the Medical Research Council of South Africa (MRC), research professor of paediatrics at the University of the Witwatersrand and a director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto, will lead the study.
The vaccine, said NIAID director, Dr Anthony Fauci, was a product of years of study and experimentation. Fauci is also the founder of the trials.
The vaccine was currently being tested in the smaller initial trial, in the US Military HIV Research Programme-led clinical trial in Thailand, which had delivered landmark results in 2009.
The Thailand trial had found that the vaccine was 31.2 percent effective at preventing HIV infection during the three-and-a-half years after vaccination, although it appeared to have been 60 percent effective one year after vaccination.
Fauci said: “A safe and effective HIV vaccine could help bring about a durable end to the HIV/Aids pandemic and is particularly needed in southern Africa, where HIV is more pervasive than anywhere else in the world.”
Study participants will receive the, “standard of care for preventing HIV infection”.
This includes condoms and lubricant, counselling on how to reduce behaviours that increase risk for infection, access to management of other sexually transmitted infections, information on voluntary medical male circumcision and referral to circumcision services, and counselling and referral for antiretroviral to take immediately after suspected exposure to HIV (post-exposure prophylaxis).
Participants will also be referred to available local programmes where they may obtain the oral medication, Truvada, to take daily for HIV prevention, a highly-effective practice called pre-exposure prophylaxis (PrEP).
Participants who become HIV-infected during the trial will be referred to local medical providers and will be counselled on how to reduce their risk of transmitting the virus. Results were expected in 2020.
Daily News