HQ Team
January 19, 2023: Johnson & Johnson stopped the phase III trial of its global HIV vaccine trial after it found that the regimen was ineffective in preventing the infection compared to the placebo participants.
“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, MD, 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.
“We remain steadfast in our commitment to advancing innovation in HIV. We hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine.”
Mosaico, a phase III study of Janssen’s investigational HIV vaccine regimen, began in 2019 and completed vaccinations in October 2022.
Gay, transgender
The study included approximately 3,900 gay men and transgender people and represented groups and populations vulnerable to HIV.
Participants at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States were observed during the study period.
The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector administered during four vaccination visits over one year.
During the third and fourth visits, a mix of soluble proteins was also administered.
“The Mosaico analysis, based on the data available to date, indicated that the regimen does not protect against HIV, and the study is not expected to meet its primary endpoint,” according to a statement.
“In light of this, the study will be discontinued, and further analyses are underway.”
Primary analysis
The study’s independent Data and Safety Monitoring Board’s decision follows the primary analysis of the Phase IIb Imbokodo study, which was announced in August 2021.
It found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa.
A global public-private partnership including the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, the HIV Vaccine Trials Network, the US Army Medical Research and Development Command, and Janssen Vaccines & Prevention BV led the Mosaico study.
Since 2005, Janssen Vaccines & Prevention BV has been participating as a sub-grantee in the preclinical and clinical AIDS Vaccine Development.
Dapivirine ring
In January 2021, Johnson & Johnson’s dapivirine ring, a discreet, long-acting HIV prevention method specifically developed for women by the International Partnership for Microbicides (IPM) and based on Janssen’s compound, was recommended by the WHO 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 Mach 2022.
