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Phase I AIDS Vaccine Trial Starts, Testing a Prime-Boost Combination

October 22, 2010

New York, October 22, 2010 —The International AIDS Vaccine Initiative (IAVI) today announced the start of a Phase I clinical trial to evaluate the safety and immunogenicity of two preventive AIDS vaccine candidates. The trial, called B003/IPCAVD-004, is the first to test these vaccine candidates in a prime-boost combination, a regimen in which vaccines are given sequentially to boost immune responses. The candidates are based on vectors made from adenovirus serotype 26 and adenovirus serotype 35, each containing synthetic versions of the Env gene of HIV.The study vaccines do not contain the HIV virus, and it is not possible to be infected with HIV from these study vaccines.

The trial is a joint effort of IAVI; the Beth Israel Deaconess Medical Center (BIDMC); the HIV Vaccine Trials Network; the National Institute of Allergy and Infectious Diseases’ Division of AIDS; the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard University; and the biopharmaceutical company Crucell. The trial may eventually involve as many as six clinical research centers in the U.S. and Africa.

Vaccinations in the trial have begun at the Brigham and Women’s Hospital in Boston. IAVI has applied for approval to add additional arms of the trial in Kenya, Rwanda and South Africa. The aim is to enroll approximately 212 healthy volunteers between the ages of 18 and 50. The trial is expected to take approximately 24 months to complete.

The trial partners are interested in testing the vaccine candidates in prime-boost combination because such regimens, compared to using either type of vaccine alone, can induce different types of immune responses or enhance the responses. Specifically, a sequential prime-boost regimen of the two different candidates may induce both antibody and T-cell responses, and thus elicit a response of greater magnitude, broader potency and longer duration than would either vaccine candidate alone. To put that possibility to the test, the trial will assess the two candidate vaccines delivered in four different prime-boost regimens.

Developed at the Beth Israel Deaconess Medical Center, the Ad26.ENVA.01 vaccine candidate is manufactured by the Dutch biopharmaceutical company Crucell. The Ad35-ENV vaccine candidate, developed by IAVI, is manufactured by France’s Transgene.

Previous studies in the US in which BIDMC and IAVI have been involved suggest that adenovirus serotypes 26 and 35 are both safe and hold promise as vehicles for AIDS vaccines. Preliminary data from a BIDMC Phase I study evaluating the Ad26-based vaccine candidate show the candidate had a good safety profile and that it elicits 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 had a good safety profile and elicited immune responses in humans.

IAVI is the sponsor of the trial. The HIV Vaccine Trials Network, the National Institute of Allergy and Infectious Diseases’ Division of AIDS and the Ragon Institute are co-funders, with IAVI.


About AIDS vaccines

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 7,400 are newly infected with the virus. Scientists are following 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 from around the world, working together toward the common goal of ending AIDS.

About IAVI
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, see www.iavi.org.

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