13 new AIDS vaccine clinical trials initiated in 2006

This annual publication provides the only comprehensive listing of all AIDS vaccine clinical trial activity worldwide.

Last year saw the start of the first AIDS vaccine trials in the Russian Federation and Zambia, and three countries in sub-Saharan Africa —Kenya, Uganda, and Tanzania—also initiated new trials. The United States, United Kingdom, Sweden and Peru began new trials in 2006 as well. Many of these trials were sponsored by new research groups, including the Karolinska Institute in Sweden, St. George’s University of London and the Moscow Institute of Immunology.

All of the new trials that began last year were either Phase I or Phase I/II trials designed to evaluate the safety and immunogenicity of the candidate vaccines. “Although these new trials are early-stage, they will provide critical information over the coming years that will help drive the field’s R&D agenda. We hope to begin to see even more novel vectors, as well as approaches that target neutralizing antibodies in the next few years,” said CEO and President of IAVI, Dr. Seth Berkley.

IAVI and its collaborators are currently conducting four ongoing trials in India, Kenya, Rwanda, Uganda, South Africa and the United States. In 2006, IAVI launched a Phase II trial in Uganda and Zambia, part of a multi-site study that also included three sites in South Africa. The South Africa, Uganda and Zambia trial sites are now fully enrolled with data expected later this year.

Two of the most advanced trials underway in 2007 are from Sanofi-Pasteur and Merck & Co., Inc. Data from Merck’s ongoing Phase IIb test-of-concept trial with its adeno-5 vector vaccine candidate is expected in 2008-2009 and will provide preliminary information on the efficacy of this type of vaccine candidate. These results will have significant implications for the field’s future research and development efforts. The company will also soon be starting an additional Phase IIb trial with the same candidate in South Africa.

The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 4.3 million people were newly infected with HIV last year—bringing the total number of HIV-infected individuals to 40 million people worldwide. Explosive HIV epidemics also continue in Eastern Europe and Central Asia. Throughout the world, a preventive AIDS vaccine remains one of the greatest hopes for stemming the pandemic.

The 2006 IAVI VAX Map, which provides detailed information on all ongoing preventive AIDS vaccine trials, is available at http://www.iavireport.org/Vax/VAXJanuary2007.asp.