HIV Vaccine Trials on Gay, Bi Men to Begin in U.S., Europe

Source: Bloomberg News

Johnson & Johnson is preparing to test an experimental HIV vaccine in the U.S. and Europe in a move toward developing the first immunization against the deadly disease after decades of frustration.

Some 3,800 men who have sex with men will receive a regimen of shots in a study that’s planned to be launched later this year, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said in an interview. The agency and the HIV Vaccine Trials Network of testing sites will collaborate with J&J’s Janssen unit on the effort.

Since cases first began to gain notice in the early 1980s, scientists have been searching fruitlessly for a vaccine against the virus that causes AIDS and kills close to 1 million people worldwide annually. Efforts are continuing with at least two other promising candidates in late-stage studies.

“The cost of treating HIV patients — the burden for patients, the burden for society — is very high,” said Paul Stoffels, J&J’s chief scientific officer. HIV prevention is “a big mission for us. We’ve been working on it for almost 30 years.”

J&J’s vaccine has four components that target multiple strains of HIV, and Barouch has been developing it for about 15 years. He and Bette Korber, a computational biologist at Los Alamos National Laboratory, designed an optimized set of “mosaic” proteins to go in the vaccine that would raise immune defenses against a wide variety of strains.

The vaccine uses a cold virus that’s altered to make the proteins that raise immunity. Study participants get six shots in four sessions. “Conceptually it’s an interesting idea,” Fauci said. “There’s always excitement, but it should be saved for the results.”

Along with the diversity of strains, HIV presents a number of obstacles to vaccination. Reservoirs of the virus can accumulate within certain cells, undetected by the immune system. No one has been able to fashion a vaccine that brings forth broadly neutralizing antibodies, the body’s most effective protection against viruses. Still, the J&J vaccine has provided protection in up to two-thirds of tested animals and has so far proven safe in humans.

Even if the first study fails, J&J would likely continue the second, said Hanneke Schuitemaker, head of viral vaccine discovery and translational medicine for Janssen. Given the differences between the two populations and their typical routes of infection, the vaccine’s dynamics in them may vary dramatically.

J&J gained the vaccine when it made a 2010 agreement to buy Dutch drugmaker Crucell for about $2.4 billion. To be successful, the product will have to succeed where a series of predecessors have stumbled.

Continued interest of large pharma companies like J&J is a good sign after the years of frustration in an field where the market remains uncertain, said Marie-Paule Kieny, a director of research at French biomedical institute Inserm.

“This is a good step forward,” she said, noting that J&J is also developing a vaccine against Ebola. “It’s good to see that industry remains committed.”

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