SAAVI news releases
3 November 2003

First HIV vaccine trial commences in South Africa

SAAVI announced today that the first vaccinations will take place this week for the first human clinical trial of an HIV vaccine in South Africa. This is a phase I clinical trial of the AlphaVax replicon Vector (ArVTM) clade C candidate HIV-1 vaccine to assess the safety and immune system responses induced by this new vaccine technology. The trial involves volunteers in the USA and South Africa. The first 12 US volunteers received their vaccinations in July and the first South African volunteers will receive theirs this week.

This is one of two candidate vaccines approved earlier this year for phase I testing by the Medicines Control Council. The second trial of the modified vaccinia Ankara (MVA) candidate vaccine, sponsored by the International AIDS Vaccine Initiative (IAVI), is likely to also begin in the next few weeks. The aim is to run multiple trials of promising candidates concurrently to fast track the testing process and to contribute to scientific knowledge about which approaches have a greater chance of success.

ArV is 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.

This ArV vaccine technology was developed by researchers at the University of North Carolina (UNC) and the US Army Medical Research Institute of Infectious Diseases, and 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. The International AIDS Vaccine Initiative was also a key supporter of the programme earlier in the collaboration and the US National Institute of Allergy and Infectious Diseases (NIAID) also provided support for product development. The organisations involved in conducting and funding the trial in the US and SA include the US NIAID at the National Institutes of Health (NIH) at the Department of Health and Human Services, the HIV Vaccine Trials Network and the South African AIDS Vaccine Initiative consortium partners in South Africa. The NIAID-funded and supported HVTN is conducting the trial. AlphaVax developed the vaccine, produced the vaccine material, and submitted the regulatory applications in both countries.

A total of 48 participants will be involved in the trial – 24 in the US and 24 in South Africa. These volunteers 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. This test 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.

For further details, contact:

HVTN
National Principal Investigator- SA
Dr Glenda Gray, (PHRU)
Tel: +27 (0) 11 989 9702, e-mail: gray@pixie.co.za

Clinical trial sites - SA
Dr Andrew Robinson, SAAVI HIV Vaccine Research Unit, Durban
Tel: +27 (0) 31 203 4739, e-mail: andrew.robinson@mrc.ac.za
Dr Eftyhia Vardas (PHRU)
Tel: +27 (0) 11 909 9756 or +27 (0) 83 415 4098,
e-mail: vardase@mweb.co.za

USA
Steve Wakefield, Lisabeth Bull
Tel: +1 (206) 667 1820, e-mail: BMWHRD@aol.com,
or lbull@hvtn.org
web: www.hvtn.org
Don Burke
Tel: + 410 614 5960, e-mail: dburke@jhsph.edu

SAAVI
Dr Tim Tucker, Director of SAAVI
Tel: +27 (0) 21 938 0262, e-mail: saavi@mrc.ac.za,
web: www.saavi.org.za
Michelle Galloway, Media and Communications
Tel: +27 (0) 21 938 0205, e-mail: michelle.galloway@mrc.ac.za

AlphaVax
Dr Peter Young, Dr Jeff Chulay
Tel: +1 (919) 595 0400, Fax: +1 (919) 595 0401,
e-mail: young@alphavax.com, chulay@alphavax.com,
web: www.alphavax.com

NIH
Laurie Doepel, NIAID Press Office, tel: +1 (301) 402 1663