Phase I Clinical Trial to Test Combination of Two Experimental HIV Vaccine Components
New York, February 28, 2011 - The International AIDS Vaccine Initiative (IAVI) today announces the start of a multi-center Phase I trial in Africa to evaluate the safety and immunogenicity of a preventive AIDS vaccine candidate made up of two components. The trial, named B002, is the first to test these components used in combination, with the aim of producing broader and stronger immune responses than can be achieved with either component alone. One component of the vaccine combination is based on a recombinant protein. The other is constructed using a virus other than HIV as a vector to transport man-made versions of HIV genes into the body. The trial is sponsored by IAVI and will be conducted in partnership with GlaxoSmithKline (GSK), the Kenya AIDS Vaccine Initiative (KAVI) and as many as three other partners in Africa pending approvals.
Vaccinations in the trial have begun at KAVI in Nairobi, Kenya. IAVI has applied for approval for additional arms of the trial in Lusaka, Zambia and in Entebbe and Masaka in Uganda. In total, the trial will enroll approximately 140 HIV-uninfected volunteers between the ages of 18 and 40. The volunteers will receive either a combination of the two vaccine components or placebo injections at three different time intervals. The trial is expected to take about 20 months to complete.
The protein-based vaccine component was developed and manufactured by GSK, a global research-based pharmaceutical and healthcare company headquartered in Brentford, England. Its active ingredients are purified proteins, synthetic copies of conserved - or relatively unchanging - parts of the highly mutable HIV, based in this case on subtype B of the virus. The vaccine component also contains an adjuvant, a substance that is added to vaccines to boost the immune system's response to the vaccine. Neither this vaccine component, nor the second, contains any part of actual HIV, and it is not possible to be infected with HIV from these study vaccines.
The other vaccine component was developed by IAVI and is manufactured by the biopharmaceutical firm Transgene, headquartered in Strasbourg, France. It is a viral vector vaccine component made from a version of Adenovirus serotype 35 (Ad35) that has been stripped of its ability to replicate inside cells. The vector carries synthetic copies of several genes (gag, reverse transcriptase, integrase and nef) based on HIV subtype A.
Previous preclinical and Phase I studies suggest that both vaccine components have potential for use as components in an AIDS vaccine. In a Phase I study conducted in Ghent, Belgium, the adjuvanted HIV protein vaccine component exhibited an acceptable safety profile, was generally well-tolerated and elicited good CD4+ T-cell immune responses in humans. Preliminary data from an IAVI-sponsored Phase I study in Rochester, New York, of an Ad35-based vaccine candidate known as Ad-35-GRIN/ENV indicate the candidate was generally safe and well-tolerated and elicited good CD8+ T-cell immune responses in the majority of volunteers.
"We are excited to be embarking on this trial with GSK and our partner research centers in Africa," said Wayne Koff, Chief Scientific Officer at IAVI. Added KAVI Principal Investigator Dr. Gloria Omosa-Manyonyi of the University of Nairobi, "This is a time of remarkable advances in the effort to develop AIDS vaccines, and we look forward to the study's outcome as we pursue that important goal."
An AIDS vaccine is urgently needed to help control the AIDS pandemic and stop the spread of HIV. Worldwide, 33 million people are living with HIV, and every day some 7,100 are newly infected with the virus. Scientists are building upon important evidence from clinical and laboratory observations that immunity-induced prevention or control of HIV infection is achievable. The effort to develop an AIDS vaccine is driven by partnerships between academic, government, commercial and non-profit institutions around the world, working together toward the common goal of ending AIDS.
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 25 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI was founded with the generous support of the Alfred P. Sloan Foundation, The Rockefeller Foundation, The Starr Foundation, and Until There's A Cure Foundation. Other major supporters include the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust; the Governments of Canada, Denmark, India, Ireland, Japan, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government (Spain), the European Union as well as the National Institute of Allergy and Infectious Diseases and The City of New York, Economic Development Corporation; multilateral organizations such as The World Bank and The OPEC Fund for International Development; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Pfizer Inc, and Thermo Fisher Scientific Inc.; leading AIDS charities such as Broadway Cares/Equity Fights AIDS; and many generous individuals from around the world. For more information, seewww.iavi.org.