Biospectator Reporter Seo Yoon-seok
Data Safety Monitoring Committee (DSMB) analysis results..HIV infection prevention effect is low, and it is difficult to expect to meet the primary end point
Janssen stopped development of its phase 3 HIV vaccine candidate ‘Ad26.Mos4.HIV’. Janssen stopped phase 2b clinical trial of Ad26.Mos4.HIV in women in Africa last year due to low preventive effect.
To date, there is no approved HIV vaccine, and Moderna and Vir Biotechnology are conducting initial clinical trials of HIV vaccines.
Janssen announced on the 18th (local time) that it is discontinuing phase 3 development of its HIV vaccine candidate Ad26.Mos4.HIV.
This is because it is less effective than a placebo. According to the announcement, the Data Safety Monitoring Board (DSMB) recommended Janssen to discontinue development, judging that the infection prevention effect of Ad26.Mos4.HIV was not effective compared to placebo, so it would be difficult to meet the primary endpoint.
Ad26.Mos4.HIV is a vaccine candidate using four mosaic antigens, and is a method in which several antigen sequences of the target virus are recombined to expand the antigen recognition range of T cells.
From 2019 to 2022, this clinical trial was conducted on 3,900 patients in 50 places including Argentina, Brazil, and Mexico. The trials involved people at risk of HIV infection, including cisgender men and/or transgender people who had sex with cisgender men and/or transgender people. Cisgender refers to a person whose biological sex and gender identity match, and is the opposite of transgender.
Janssen discontinued clinical development in August of last year in the phase 2b clinical trial of Ad26.Mos4.HIV, which was conducted on 2,637 women aged 18 to 35 years in Africa, with a preventive efficiency of 25.2%, showing no significant difference compared to placebo.
No safety issues were found in either clinical trial.
Penny Heaton, Director of Research and Development at Janssen, said, “We are disappointed with these results, but we will continue to work to innovate in the field of HIV. said.
