Media statements

SAAVI/HVTN NEWS RELEASE

South African developed HIV vaccines begin testing in the US and SA

28 November 2008      

Two South African developed HIV vaccines have begun clinical testing in the United States, and will soon begin testing in South Africa in early January 2009.  The South African AIDS Vaccine Initiative (SAAVI), which is a lead programme of the Medical Research Council and is supported by the South African government, this week announced the start of the phase I safety trial in the USA.  The trial, called SAAVI 102/HVTN 073, will be conducted jointly with the HIV Vaccine Trials Network (HVTN) and the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).  It will test two vaccines developed by the University of Cape Town through joint funding from SAAVI and NIAID, NIH.

The development of these vaccines is the culmination of eight years of research and development which has involved scientists across South Africa and globally. The vaccine designs are based on HIV subtype C, the dominant strain circulating in southern Africa. They are the first HIV test vaccines developed in Africa to make it into human clinical trials.  This phase I trial will start in Boston, in the USA next week. Testing in South Africa will start in early January 2009. The trial has been approved by the South African Medicines Control Council (MCC) and the Directorate of Biosafety in the Department of Agriculture (which approves products using genetically modified organisms). The US arm of the trial will involve 12 participants whilst the South African arm aims to recruit 36 participants from two sites, one in the Western Cape and another in Gauteng.

The test vaccines – called SAAVI MVA-C and SAAVI DNA-C2 – have shown promising results in animal testing. The SAAVI DNA-C2 vaccine was constructed in South Africa using a plasmid backbone provided by the Vaccine Research Centre (VRC) of NIAID, part of the NIH, while the MVA vaccine was designed by the team at UCT and constructed and manufactured in the USA.

“We are delighted that this vital project has reached such a critical stage in its development and I would like to take this opportunity to thank all of the people who have contributed their time and expertise to allow us to reach this point,” says Prof. Anna-Lise Williamson, leader of the team at University of Cape Town’s Institute for Infectious Disease and Molecular Medicine. “This is a massive achievement, for us it is the culmination of eight years’ work, made possible, to a large extent, by SAAVI funding and a strong partnership with NIH.”

The SAAVI DNA-C2 was constructed in South Africa and manufactured in the US by Althea Technologies. The MVA vaccine was manufactured by Therion Biologics, USA. The vaccines will be tested in a prime-boost approach where the SAAVI DNA-C2 vaccine will be given to prime the immune system and the SAAVI MVA-C vaccine to boost or enhance the immune system response.

“This clinical trial represents a milestone for South Africa, as one of the few developing countries to have developed an HIV vaccine and progressed it into human clinical trials. It is progress in the search for an HIV vaccine which would provide the best chance to halt the global HIV epidemic; as well as a significant step in South Africa’s growing competence in complex vaccine development,” says Prof. Anthony MBewu, President of the Medical Research Council.

A phase I trial for an HIV vaccine generally involves volunteers who do not engage in risky sexual behaviours or intravenous drug use and are therefore at low risk for infection. A phase I trial primarily tests for safety, tolerability and side-effects but also starts to look at the effect of the vaccine on the human immune system. If successful, a phase I trial is followed by larger phase II and III trials which involve more volunteers and provide information on whether the product is able to protect against infection. A vaccine can only be licensed for public use after it has been tested and found successful in all three phases of clinical trials.

“While there have been recent disappointments in vaccine research, we need to keep trying to find an HIV vaccine as this is our best hope of ultimately controlling this devastating epidemic,” says Glenda Gray, lead investigator on the clinical trials team.

 “SAAVI is extremely gratified that these test HIV vaccines are entering human clinical trials,” says the Interim Director of SAAVI, Elise Levendal. “There is still a long way to go before we will know if these products will be in any way successful in preventing HIV infection. However, this important progress has been made possible by the excellent collaboration of the scientists, researchers and communities.”  

“Interventions to prevent the spread of  HIV infection are urgently needed and the news that testing of a new vaccine in the USA will commence this week is thus welcomed, says Prof. Greg Hussey, Director of the Institute of Infectious Disease and Molecular Medicine. “The IIDMM and UCT are extremely proud to be associated with the SAAVI, who have been involved in the development of the vaccine.”

About SAAVI (www.saavi.org.za)
SAAVI is an initiative of the South African government, and a lead programme of the Medical Research Council. Founded in 1999 by Eskom, the Department of Health, and the Department of Science and Technology, SAAVI seeks to co-ordinate the research, development and testing of HIV vaccines in South Africa to arrive at an effective, safe, affordable and locally relevant AIDS vaccine as quickly as possible. SAAVI funds and co-ordinates activities of investigators at South African academic institutions.  The activities include: laboratory development of vaccines; immunology; testing of vaccines in clinical trials; ethics and behavioural research; community education and involvement; and, and bioinformatics.  SAAVI works and collaborates with key national and international partners, and has both an internal research and development arm aimed at investigating and developing novel candidate vaccines, as well as extensive and widespread clinical infrastructure for testing both our own and vaccines developed internationally.

About the MRC (www.mrc.ac.za)
The MRC is a statutory organisation established by an Act of Parliament in 1969. Its mission is to improve the nation’s health and quality of life through promoting and conducting relevant and responsive health research.

About the University of Cape Town’s Institute for Infectious Disease and Molecular Medicine
The Institute of Infectious Disease and Molecular Medicine (IIDMM) is a postgraduate research institute within the University of Cape Town’s Faculty of Health Sciences.   Launched in 2005, it concentrates its efforts on infectious diseases, particularly on HIV/AIDS and Tuberculosis, diseases that particularly threaten sub-Saharan Africa, as well as other prevalent non-communicable diseases.

Over the past decade, the University, and particularly the IIDMM, have transformed their research activities to meet the needs of people in Africa, ensuring that their work is translational - their discoveries and pursuits are taken from their laboratories and applied in the communities of Africa and elsewhere. The SAAVI project is an excellent example of such an activity.

About the HIV Vaccine Trials Network (www.hvtn.org)
The HVTN is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is a unique hybrid that combines the depth and diversity of the academic community and the flexibility of a commercial drug company. Working with industry and government, the HVTN seeks to expedite and co-ordinate the trial process, advancing vaccine candidates and building a body of knowledge around HIV vaccine trials. The HVTN is funded through a cooperative agreement with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, an agency of the US Department of Health and Human Services (DHHS). The HVTN comprises more than 25 research institutions worldwide, co-ordinated from its headquarters at Fred Hutchinson Cancer Research Center in Seattle, Washington.

About the National Institute of Allergy and Infectious Diseases (www3.niaid.nih.gov)
NIAID is a component of the United States National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

About DAIDS (Division of AIDS at the National Institutes of Health)
DAIDS is a division of the US National Institute of Allergy and Infectious diseases (NIAID). It was established in 1986 to develop and implement the US national research agenda to address the HIV/AIDS epidemic.
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For further details, contact:

South Africa

Glenda Gray (Protocol Chair, lead clinical investigator), +27 11 989 9703, gray@pixie.co.za, 083 459 2680

Anna-Lise Williamson (Director of UCT SAAVI product development programme) +27 21 406 6124, Anna-lise.Williamson@uct.ac.za, 083 462 8798

Carolyn Williamson, Leader of the UCT DNA MVA preclinical group, +27 21 406 6683, carolyn.williamson@uct.ac.za , 082 740 7298

Prof Anthony MBewu, MRC President, 082 440 3073

Elise Levendal, Interim Director of SAAVI, 082 454 4901

Julian Jacobs, (MRC Communications Manager) +27 (0) 21 938 0241, julian.jacobs@mrc.ac.za , 082 454 4902

United States

Sarah Alexander (HVTN Associate Director for Communications and External Relations) +1.206.667.5296, salex@hvtn.org