Johnson and Johnson HIV Vaccine Fails in Advanced Trials

Johnson and Johnson announced last week that a clinical trial for a potential HIV vaccine has closed after researchers found the experimental drug did not protect patients from contracting the virus. Researchers at the Johnson & Johnson-owned company, Janssen Pharmaceuticals, confirmed they would end the phase 3 Mosaico trial, after the study’s independent data and safety monitoring board determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified.

The Mosaico trial began in 2019 and aimed to create a mosaic-style vaccine by combining materials from several different strains of the Human Immunodeficiency Virus. Just under 4,000 participants including cisgender men and transgender people throughout the U.S., South America, and Europe received doses of the experimental vaccine. It was the only HIV vaccine currently in late-stage clinical trials, however, several other HIV vaccine trials are underway, including four by Moderna. Experts conjecture that the failure of the trial’s failure would set back a reliable HIV vaccine by 3-5 years.

A spokesperson for the National Institute of Allergy and Infectious Diseases, which partnered with J&J in the trial, told Reuters that although this failure was “not the outcome we had hoped for,” researchers “will learn from this study and continue forward.”

“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” says Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge.”

In January 2021, the dapivirine ring, a discreet, long-acting HIV prevention method specifically developed for women by the International Partnership for Microbicides, based on Janssen’s compound, was recommended by the World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches. In July 2021, Zimbabwe became the first country to approve the use of the dapivirine ring among women ages 18 and older, with South Africa following suit in March 2022.

Another mosaic-type vaccine, HIV-CORE 0052, concluded Phase 1 testing in September 2022; over the past year and a half, rival pharmaceutical corporation Moderna has begun trials for four different HIV vaccines, one of which entered human trials last January and has already shown that it has promise in producing an immune response.