The South African Aids Vaccine Initiative (Saavi) announced on Monday that the first vaccinations will take place this week for the first human clinical trial of an HIV vaccine in South Africa.
Addressing a press conference in Johannesburg, Saavi director Dr Tim Tucker said two separate clinical trials would start in Johannesburg and Durban this week and next.
”This is an incredibly exciting time,” Tucker said.
Tucker and a panel of experts explained that the first medication on trial was the AlphaVax replicon Vector (ArV) clade C candidate HIV-1 vaccine.
Phase I of the trials would assess the safety and immune system responses induced by the vaccine technology.
The trial involves volunteers in the United States and South Africa. The first 12 US volunteers received their vaccinations in July.
Forty-eight South Africans and Americans will eventually be involved in the programme.
The Alphavax product was one of two candidate vaccines approved earlier this year for testing by the Medicines Control Council (MCC).
The second trial of the Modified Vaccinia Ankara (MVA) candidate vaccine, sponsored by the International Aids Vaccine Initiative (IAVI), was likely to also begin in the next few weeks.
Tucker added that the trials enjoyed support from ”the highest levels of government.”
He said he had personally briefed Health Minister Manto Tshabalala-Msimang and had received her support, and that of Science and Technology Minister Ben Ngubane. The Cabinet was also very supportive.
Tucker stressed that SAAVI was an autonomous body, but was well integrated with the South African Medicines Research Council and the IAVI.
It was committed to finding a vaccine that was ”affordable, effective and relevant.”
He said the trials were being structured in such a way that the ”ills of the past was not repeated.”
Durban clinical site supervisor Dr Andrew Robinson said lessons had been learned from previous clinical trials, particularly of anti-retroviral medication.
These trials were marked by unequal partnerships between the researchers, the volunteers and the broader community. This was an experience they were keen not to repeat.
National principal investigator Dr Glenda Gray said the trials would take up to 10 years to complete.
”We are in kindergarten now, we want to get to university,” she explained.
In a media release issued at the briefing, it was explained that ArV was a ”cutting-edge vaccine technology that was awarded the World Technology Forum Award for biotechnology in 2001. It utilises virus-like particles, containing parts of a weakened strain of Venezuelan equine encephalitis (VEE) virus and a gene from a South
African strain of HIV, to deliver the vaccine to the immune system. This is the first trial of this technology in humans.”
The HIV Vaccine Trials Network (HVTN) is conducting the trial, which will take place at two sites in South Africa — the Perinatal HIV Research Unit at the Chris Hani Baragwanath Hospital in Soweto and the SAAVI HIV Vaccine Research Unit at the Medical Research Council in Durban.
The US trial sites are Johns Hopkins University, Columbia University, the University of Rochester and Vanderbilt University.
”As the vaccine contains only a copy of a small section of genetic material from HIV, and does not include the genetic elements needed to reconstitute live HIV, there is no possibility of the vaccine itself causing HIV infection. The vaccine material is also designed so that its VEE components cannot generate VEE
virus or cause VEE infection,” the media release added.
ArV was developed by researchers at the University of North Carolina (UNC) and the US Army Medical Research Institute of Infectious Diseases.
It has been applied to HIV by an international collaboration of researchers from UNC, the University of Cape Town, the Medical Research Council in South Africa, and AlphaVax, a North Carolina biotechnology company.
Of the 48 participants, 24 will come from the US and 24 from South Africa.
They have been screened and have undergone intensive risk-reduction counselling.
A phase I trial is a safety trial, which aims to confirm that the test vaccine does not produce significant side-effects in human volunteers. Volunteers will be closely monitored to ensure their safety and that they do not expose themselves to unnecessary risk.
The vaccine has already been extensively tested in laboratory and animal studies.
The trial protocol was reviewed and approved by the US Food and Drug Administration (FDA) as well as by multiple ethics committees in South Africa and the USA.
Volunteers will be involved in the trial for about a year and, with data analysis, the trial will last approximately two years.
MVA, the second vaccine on trial, was being researched by IAVI, the University of Nairobi, the University of Oxford, the British Medical Research Council and the Uganda Virus Research Institute.
A small-scale trial was approved by the South African MCC in August. – Sapa