SAAVI news releases
19 June 2003

Medicines Control Council approves first HIV vaccine trial in South Africa

SAAVI announced today that the South African Medicines Control Council (MCC) has approved the first human clinical trial for a phase I HIV vaccine trial in South Africa. This is a phase I human 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 will involve a small number of volunteers in both the USA and South Africa. The approval was the subject of a separate MCC announcement.

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 an attenuated strain of Venezuelan equine encephalitis (VEE) virus and a gene from a South African strain of the HIV virus, to deliver the vaccine to the immune system. This is the first trial of the ArV technology in humans.

The HIV Vaccine Trials Network (HVTN) is conducting the trial, which will take place at two clinical trial sites in South Africa – the Perinatal HIV Research Unit at the Chris Hani Baragwanath Hospital in Soweto and the SAAVI 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 in such a way that its VEE components cannot generate VEE virus or cause VEE infection.

This ArV vaccine technology was originally 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 (IAVI) 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 (HVTN) and the South African AIDS Vaccine Initiative consortium partners in South Africa. The NIAID-funded HVTN is conducting the trial. AlphaVax developed the vaccine, produced the vaccine material, and submitted the regulatory applications in both countries.

A total of 96 participants will be involved in the trial – 48 in the US and 48 in South Africa. Twenty four volunteers are required at each South African site and recruitment activities are continuing in preparation for the first vaccinations. Volunteers will be healthy, HIV-negative adults who are willing and able to give informed consent. Intensive pre-recruitment educational and community awareness activities have been conducted at both sites in South Africa. The study that has been approved will begin by enrolling 12 volunteers in the US, and additional volunteers will be enrolled in the US and SA once initial safety data from these 12 volunteers has been reviewed.

Potential volunteers will be supplied with detailed information about the candidate vaccine. Volunteers will undergo intensive risk-reduction counselling and clinical monitoring on an ongoing basis throughout the trial to ensure their safety and that they do not expose themselves to unnecessary risk.

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 in this study will be closely monitored over a 12 month period. This test vaccine has already been extensively tested in laboratory and animal studies. The phase I clinical trial protocol has also been 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 it is anticipated that with data analysis the trial will last approximately two years.

This is the first HIV vaccine trial to be approved in South Africa and the first in the world to test a subtype C vaccine.

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 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, lbull@hvtn.org
www.hvtn.org

SAAVI
Dr Tim Tucker, Director of SAAVI
Tel: +27 (0) 21 938 0262, e-mail: saavi@mrc.ac.za,
www.saavi.org.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, www.alphavax.com

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