J&J's HIV vaccine shows promise in monkeys; PhI/IIa to start soon

The search for an HIV vaccine has been long and difficult, but researchers from Johnson & Johnson ($JNJ), Harvard and other groups may have made a leap. J&J's Janssen reported encouraging results Thursday from its preclinical trial of an HIV vaccine in rhesus monkeys. Encouraging enough for the company to sponsor human studies--the first time a Big Pharma is doing so in the HIV space.

According to BioSpace, the trial involved 24 monkeys. The vaccine protected half of them from SIV--simian immunodeficiency virus, a virus similar to HIV. J&J is seeking 400 volunteers for a Phase I/IIa study. Enrollment has started in the U.S. and Rwanda, with sites in South Africa, Uganda and Thailand opening soon, J&J said in a statement.

"We are very encouraged by the results of this preclinical HIV vaccine study, and the findings lead to a clear path forward for evaluating this HIV vaccine candidate in humans," lead author Dr. Dan Barouch, of the Beth Israel Deaconess Medical Center and Harvard Medical School, said in a statement. Though Barouch said that a vaccine that protects monkeys may not necessarily protect humans, he is optimistic, BioSpace reported.

Like its Ebola candidate, J&J's HIV vaccine uses a "prime-boost" approach. The first shot, an adenovirus, causes the immune system to make antibodies, and the second booster shot of a purified HIV envelope protein enhances the immune response over time, the company said in the statement.

The WHO estimates 78 million people have been infected with HIV, and about 39 million have died from the disease.

"Even protecting half of the people who are exposed to the virus would be a major accomplishment," said Dr. Mary Marovich, director of the Vaccine Research Program at the National Institute of Allergy and Infectious Diseases (NIAID), as quoted by BioSpace. "It could ultimately end the epidemic when you use it in combination with other measures."

In 2007, a Data and Safety Monitoring Board concluded that data from an NIAID-funded trial couldn't show that Merck's ($MRK) HIV candidate prevented infection. Since then, a team from the Scripps Research Institute has begun talking to federal regulators to discuss human trials of their HIV candidate, Duke University won a $20 million NIH grant to develop a vaccine and Vical ($VICL) inked a deal with the IPPOX Foundation to supply plasmid DNA for HIV vaccine trials.

- here's the release and the abstract
- read the BioSpace story
- get FierceBiotech's take

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