An independent data and safety monitoring board (DSMB) has found the experimental HIV vaccine regimen to be safe but ineffective in HIV transmission in a test group of men who have intercourse with men and transgender people.
The HPX3002/HVTN 706 or “Mosaico”, Phase 3 clinical trial began in 2019. It involved
3900 male participants aged 18 to 60 years from Europe, South America, and North
America. The trial is now discontinued based on the recommendations of DSMB.
The Mosaico study was sponsored by Janssen Vaccines & Prevention B.V., part of the
Janssen Pharmaceutical Companies of Johnson & Johnson, with funding support from the National Institute of Allergy and Infectious Diseases (NIAID).
The experimental regimen developed by Janssen comprised four injections over the course of one year of Ad26.Mos4.HIV.
DSMB found out that there were no safety issues with the vaccine during the data review, but the HIV infection was the same between the vaccine and placebo groups of the study.
The participants were given all the HIV prevention tools and pre-exposure prophylaxis, and
those who acquired the infection during the trial were immediately given medical treatment.
The findings of this study were found to be similar to a 2021 study in young sub-Saharan
African women: the Phase 2b “Imbokodo” clinical trial. Here too, the experimental HIV
vaccine regimen was found to be safe but ineffective in protecting against HIV infections.
Source: www.nih.gov