News Release

SAAVI / HVTN NEWS RELEASE
First South African developed HIV vaccines begin testing in SA

CAPE TOWN: Two South African developed HIV vaccines have begun clinical testing in South Africa (Crossroads, Cape Town and at Chris Hani Baragwanath Hospital, Soweto). This follows the successful enrolment and vaccination of 12 volunteers in Boston, MA, USA. The South African AIDS Vaccine Initiative (SAAVI), which is a lead programme of the South African Medical Research Council (MRC) and is supported by the South African government, this week announced the start of the phase I safety trial in SA. The trial, called SAAVI 102/HVTN 073, is being 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 (UCT) through joint funding from SAAVI and NIAID.

The US arm of the trial has 12 participants whilst the South African arm plans to recruit 36 participants from two sites, one in the Western Cape and another in Gauteng.

“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,” says Prof. Anthony Mbewu, President of the South African Medical Research Council.

“During 2007 – 2008 SAAVI experienced severe funding difficulties and globally we realized that we are still far from effectively preventing HIV infection. Despite this, we are confident that through our support for the basic science, trial site development, community involvement and ethics we are contributing to empowered South African communities working in a mutually beneficial and meaningful partnership with researchers. The start of the SAAVI 102/HVTN 073 trial has been made possible by the excellent collaboration between researchers, scientists and communities,” says the Interim Director of SAAVI, Elise Levendal.

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 Dale and Betty Bumpers Vaccine Research Center (VRC) of NIAID, while the MVA vaccine was designed by the team at UCT and constructed and manufactured in the USA.

“Reaching this important milestone of translating our discoveries in the laboratory to testing in humans would not have been possible without the support of a large team of people from the University of Cape Town, together with national and international collaborations.  An effective vaccine against HIV/AIDS remains a top global health priority and it is our hope that the evaluation of these vaccines in clinical trial will provide some important answers that will bring us closer towards this goal,” says Prof. Anna-Lise Williamson, leader of the vaccine development team and joint staff member of UCT’s Institute for Infectious Disease and Molecular Medicine, and the National Health Laboratory Services (NHLS).

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 response and the SAAVI MVA-C vaccine to boost or enhance the immune response.

The trial has been reviewed by the US Food and Drug Administration (FDA) who allowed the trial to move forward through the usual review process. It has also 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). Institutional Review Boards (IRBs) or Research Ethics Committees (RECs) at each participating institution have also reviewed and approved the trial.

“We have been eagerly awaiting the go ahead to begin recruiting on to this landmark study. Both the Cape Town and Johannesburg sites have been preparing communities, potential recruits and undergoing site preparation for some time. It is important that we recruit the most suitable people for the study and sites have been preparing diligently for many months now,” says Prof. Linda-Gail Bekker, Principal Investigator for the Cape Town trial site and Director of the Desmond Tutu HIV Foundation. 

“If data from this clinical trial is promising, we intend to move into the next phase of trials which will involve about 200 participants, and will look at further safety and immunogenicity data,” says Prof. Glenda Gray, lead Clinical Investigator of the South African clinical trials team.

Prof. Greg Hussey, Director of the Institute of Infectious Disease and Molecular Medicine says, “The IIDMM and UCT are extremely proud to be associated with SAAVI, who have been involved in the development of these two vaccines.”

The clinical trial is sponsored by the Division of AIDS (DAIDS), within the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), an agency of the US Department of Health and Human Services (DHHS).
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Note to Editor:
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 immunogenicity or the effect of the vaccine on the human immune system. If successful, a phase I trial is usually followed by larger phase II and III trials which involve more volunteers. Phase 2 trials test for vaccine safety, immune response and the best way to give the study vaccine. Phase 3 clinical trials test if the study vaccine is effective – whether it protects against infection or if it slows disease progression to AIDS. Often there is a phase 2b trial – it produces further safety and efficacy data to give an idea of whether the vaccine is effective. The outcomes of a phase 2b study help to guide future research. A vaccine can only be licensed for public use after it has been tested and found successful in all three phases of clinical trials.

National Institute of Allergy and Infectious Diseases (NIAID) positioning statement
The US National Institute of Allergy and Infectious Diseases (NIAID) is part of the US National Institutes of Health (NIH), an agency of the US Department of Health and Human Services (DHHS). NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. To learn more about NIAID, please visit www.niaid.nih.gov.

About the HVTN
The HIV Vaccine Trials Network (HVTN) is an academically based research organization of scientists, educators and community members committed to eliminating the spread of HIV in the world by finding a safe and effective vaccine.  The Network is supported through a cooperative agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).  To learn more about the HVTN, please visit www.hvtn.org.
 
MRC positioning statement
The South African Medical Research Council (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. To learn more about the MRC, please visit www.mrc.ac.za.

SAAVI positioning statement
SAAVI was established by the South African government and Eskom in 1999 to co-ordinate the development of an affordable, effective and locally relevant HIV vaccine for southern Africa. SAAVI is a lead programme of the South African Medical Research Council (MRC). SAAVI receives direct funding from the South African government [the Departments of Health (to date) and Science & Technology (up to 2008)], ESKOM (up to end 2007) and Impala Platinum, and indirectly from international organisations including the US National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN). SAAVI works with local and international partners to achieve the common aim of finding a successful HIV vaccine. To learn more about SAAVI, please visit www.saavi.org.za.University of Cape Town, Institute of Infectious Disease and Molecular Medicine positioning statement

The Institute of Infectious Disease and Molecular Medicine (IIDMM) is a postgraduate research institute within the University of Cape Town’s (UCT) 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. To learn more about the IIDMM, please visit: www.iidmm.uct.ac.za.

Desmond Tutu HIV Centre positioning statement
The Desmond Tutu HIV Foundation (DTHF) is a registered non-profit organisation focused on the pursuit of excellence in research, treatment, training and prevention of HIV and related infections in Southern Africa.

The Desmond Tutu HIV Foundation is based in Cape Town, South Africa and is run in association with the Desmond Tutu HIV Centre (DTHC) at the University of Cape Town's (UCT) Institute of Infectious Disease and Molecular Medicine. The Foundation operates community sites in greater Cape Town's Nyanga and Masiphumelele districts. To learn more about the DTHC, please visit: www.desmondtutuhivcentre.org.za.

Perinatal HIV Research Unit positioning statementThe Perinatal HIV Research Unit (PHRU), established in 1996, is one of the largest AIDS research centres in Africa. The early research focus on prevention of mother to child transmission has expanded and PHRU now leads studies on many different aspects of HIV prevention, treatment and care including medical and social research. PHRU is a research unit of the University of the Witwatersrand (WITS), which is based in Soweto, South Africa, at Chris Hani Baragwanath Hospital, one of the world's biggest hospitals. To learn more about the PHRU, please visit: www.hivsa.com.

About the National Health Laboratory Services (NHLS)
The NHLS is the largest diagnostic pathology service in South Africa, with 265 laboratories spread over the nine provinces, serving 80% of the country’s population. The NHLS play a major role in: public health in SA through epidemiology, surveillance and outbreak response activities; the national Anti-retroviral Roll-out programme through CD4+ viral load studies and HIV treatment monitoring; tuberculosis diagnosis and treatment monitoring; screening of cervical cancer and; the support of occupational health services. Its specialised divisions are the National Institute for Communicable Diseases, the National Institute for Occupational Health and the National Cancer Registry. To learn more about the NHLS, please visit: www.nhls.ac.za
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For further details, contact:

South Africa
Prof. Glenda Gray (Protocol Chair, lead clinical investigator), PHRU +27 11 989 9703, gray@pixie.co.za, 083 459 2680
Prof. Anna-Lise Williamson (Director of DNA/MVA product development), University of Cape Town (UCT)/National Health Laboratory Services (NHLS)
 +27 21 406 6124, Anna-lise.Williamson@uct.ac.za, 083 462 8798
Prof. Carolyn Williamson (Leader of the UCT DNA/MVA preclinical group), UCT,
 +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
Mr Julian Jacobs, (MRC Communications Manager), julian.jacobs@mrc.ac.za , 082 454 4902

Spokespeople – US

NIH/NIAIDS
Ms Kathy Stover, stoverk@niaid.nih.gov, +1 (301) 451-2278 office

HVTN
Ms Sarah Alexander, The Hutchinson Center, salexand@fhcrc.org
+1 (206) 667 5296 office