Seventy-eight healthy South Africans are to test a new candidate HIV vaccine over the next 18 months.
The International Aids Vaccine Initiative (IAVI) and a United States company need to determine if the medication is safe and effective.
Called ”tgAAC09”, the preventive HIV vaccine candidate is based on HIV subtype C, the subtype of the virus most prevalent in Southern and East Africa.
”The trial should take about 18 months to complete and will enrol 78 volunteers in total — men and women — who are in good health. TgAAC09 is designed to elicit two different types of immune responses, an antibody response and a cell-mediated response. The vaccine consists of an artificially made copy of the HI virus and cannot cause HIV infection or Aids,” the IAVI said on Monday.
The trial will be conducted in three sites in South Africa:
- the perinatal HIV research unit at the Chris Hani-Baragwanath hospital in Soweto with Dr Eftyhia Vardas as the principal investigator;
- the Desmond Tutu Institute for HIV Research at the University of Cape Town with Dr Linda-Gail Bekker as the principal investigator; and
- the Medunsa campus of the University of Limpopo with Professor Anwar Hoosen as the principal investigator.
The IAVI also plans to test the vaccine in Zambia and Uganda, pending regulatory approval in those countries.
In a public-private collaboration, the IAVI is funding development, pre-clinical and clinical studies to test the vaccine.
The IAVI is a global not-for-profit organisation working to accelerate the development of a vaccine to prevent HIV infection and Aids.
The South African trial follows positive safety data received from ”phase-one” tests conducted over the past two years in Belgium, Germany and India.
Candidate vaccines that are proven to be safe in phase-one trials move on to phase-two trials, allowing investigators to test the immune response and acquire more data on safety.
This is the first phase-two HIV vaccine trial to be held in South Africa.
The IAVI estimates that there are 30 preventive HIV vaccine candidates in human trials on six continents.
”We are pleased that South Africa has taken a leading role in the testing of vaccine candidates given the medical and humanitarian promise a preventive vaccine holds,” said Vardas, who is the national protocol chairperson of the trial.
South Africa approved its first H IV vaccine trials in 2003, including one sponsored by the IAVI.
In 1999, the government created the South African Aids Vaccine Initiative (Saavi) to coordinate the research, development and testing of HIV vaccines. Saavi is the national coordinating body for vaccine research in South Africa, working with both national and international partners.
”Developing an Aids vaccine for the regions of the world in greatest need will take many more innovative partnerships like this one, given the difficult scientific challenges we face,” said Dr Seth Berkley, chief executive of the IAVI.
”Preventive vaccines have ended or helped control the most deadly infectious diseases known to man. Finding a vaccine to stop the spread of the HIV virus must be a global priority.” — Sapa