J&J gears up for clinical test of HIV vaccine efficacy

Johnson & Johnson is gearing up to test an HIV vaccine in a 3,800-person clinical trial. The preparations follow animal studies that showed the vaccine offered better protection than earlier attempts to confer immunity to the virus.

Efforts to develop HIV vaccines began in the early years of the HIV crisis, but few candidates made it to the clinic and those that did delivered underwhelming data. J&J bolstered its own efforts in the area through the $2.4 billion acquisition of Crucell in 2010. And, after 15 years of early-stage work, the Big Pharma is now poised to learn whether it can succeed where Merck, Sanofi and others failed.

Talking to Bloomberg,  Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said a trial of the vaccine candidate in 3,800 men who have sex with men will start later this year. Data could arrive in 2023. 

The history of HIV vaccine development shows the data could disappoint, but there are reasons to think this time could be different. Whereas earlier attempts to develop an HIV vaccine aimed to confer immunity against single strains of the virus, J&J’s candidate features four components designed to provide protection against multiple strains. That hypothesis survived preclinical testing intact. 

“It’s measurably better in animal studies than other vaccines tested thus far,” Bruce Walker, director of the Ragon Institute, said. Two-thirds of animals that received the vaccine gained immunity. 

The proportion of humans protected by the planned six-shot vaccine regimen will be one focal point of the anticipated clinical data set. Another focal point will be how long the people who respond to the vaccine remain protected against HIV. 

If the trial generates big numbers against those endpoints, J&J could add a valuable option to the HIV management toolkit. Gilead Sciences already sells a drug designed to stop people becoming infected, but it is taken daily, creating a compliance burden and putting the price of protection beyond the reach of many people, particularly in the parts of Africa where HIV is most prevalent.