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New AIDS vaccine trial launches
Rockefeller researchers begin testing the ‘boost’ phase of their ‘prime and boost’ strategy
The second arm of a clinical study to investigate an experimental HIV/AIDS vaccine began at the Rockefeller University Hospital in January, when two volunteers were injected with the ADMVA vaccine. Nine additional volunteers have joined the study to date and a total of 48 healthy men and women will eventually be enrolled in the protocol.
The phase I research study, which is being administered by Rockefeller research associate professor Sarah Schlesinger, is designed to evaluate the safety and immune system effects of a new vaccine called ADMVA. Developed by scientists at the Aaron Diamond AIDS Research Center (ADARC), headed by Irene Diamond Professor David Ho, the vaccine is a version of Modified Vaccinia Ankara (MVA), a vaccine that was used as part of a global smallpox eradication program in the 1970s. The ADMVA vaccine is designed to stimulate immune responses to prevent people who are uninfected with HIV/AIDS from contracting the disease. It is based on the ‘C’ strain of HIV, which is prevalent in China, India and Sub-Saharan Africa and accounts for more than 50 percent of new HIV infections.
ADMVA represents the second part of what’s known as a “prime and boost” vaccine strategy designed to first prime the body’s immune system by showing it synthetic, noninfectious parts of the HIV virus’s genetic make-up, followed by boosting its ability to stave off HIV. The first arm of the study began in December 2003, when the Rockefeller University Hospital and ADARC began testing the first part of the vaccine strategy, called ADVAX, in a phase I research study. That study is ongoing for another 6 to 12 months.
Participants in the new study, which are being recruited in New York City and at the University of Rochester Medical Center, must be healthy, HIV-negative, and at low risk of HIV infection. In addition, volunteers must plan not to become pregnant or impregnate a partner during the trial and for four months after the last vaccination. Participants are randomly assigned to receive either the experimental vaccine or placebo. The volunteers then visit the outpatient clinics 12 times over 18 months for follow-up blood work.
This smallpox vaccine on which ADMVA is based was well tolerated by animals when tested, and similar HIV vaccines made from MVA have also been well tolerated in people who received them. The ADMVA vaccine does not contain any material from live HIV, blood or blood products, or materials from individuals who are infected with HIV.
“It is absolutely not possible to get HIV infection from the ADMVA vaccine,” says Schlesinger.
A successful vaccine would potentially save millions of lives each year. “With each passing year, the grip of the disease tightens worldwide as the disease makes new inroads into heavily populated regions in Asia,” says Ho. “Developing an effective AIDS vaccine is one of the greatest challenges researchers and volunteers have ever faced. But the rewards in terms of lives that could be saved by an effective vaccine are also among the greatest in human history.”
If ADMVA proves effective, ADARC and one of the study’s funders, the International AIDS Vaccine Initiative (IAVI), are committed to ensuring that it is made available in developing countries at affordable prices.

EDITORIAL: New York City rises, again

March 18, 2005



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