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News release
22 September 2007
Vaccinations and Enrollment Are On Hold in Phambili
Saturday, 22 September 2007 - Vaccination and enrollment have been put on hold in Phambili—an HIV vaccine clinical trial in South Africa being jointly conducted by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN). The investigational vaccine was developed by Merck & Co. Inc. The vaccine being studied in Phambili is the same as one used in another international clinical trial called the Step study.
The Step study is an international phase II “test of concept” trial in uninfected volunteers at high risk for acquiring HIV infection. At a regularly scheduled meeting on 18 September 2007, the independent Data & Safety Monitoring Board (DSMB) for the Step study reviewed safety data and results of an interim efficacy analysis of the study, and recommended that vaccination be discontinued because the Step trial will not meet its efficacy endpoints. Study investigators have been instructed to discontinue vaccinating volunteers in this study and to monitor them in accordance with the study protocol.
Since Phambili and the Step study use the same vaccine, the vaccinations in Phambili have been put on hold. No-one will receive any more vaccinations until the DSMB for Phambili reviews the data from the Step study analysis and makes a recommendation on the future of Phambili. The DSMB for Phambili may recommend to discontinue all vaccinations in the study. The study is being run by the HIV Vaccine Trials Network and the South African AIDS Vaccine Initiative. The HVTN is funded by the National Institute of Allergy and Infectious Diseases at the U.S. National Institutes of Health. These partners will be included in decisions about the future of the Phambili study.
“This is a huge blow for the South African scientists, participants and the communities who have been involved in the Phambili study. HIV is ravaging our communities, and everyone involved in Phambili has been affected by this epidemic. Our endeavors to find a vaccine must not stop, we must continue the race to find a vaccine so we can secure an HIV free generation for the future” says national principal investigator Professor Glenda Gray of the Perinatal HIV Research Unit at the University of the Witwatersrand.
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 mobilisation; and, actuarial science and bioinformatics. An emphasis has been on creating novel biotechnology platforms to develop and test HIV vaccines, and developing the clinical and social environment conducive to running HIV vaccine trials. 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 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 and supported by 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 the Fred Hutchinson Cancer Research Center in Seattle.
For further details, contact:
South Africa
United States
- Sarah Alexander
HVTN Associate Director for Communications and External Relations
+1.206.667.5296, salex@hvtn.org
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