The HPX3002/HVTN 706, or “Mosaico,” Phase 3 clinical trial, which was launched in 2019, has been discontinued by the Data Safety Monitoring Board (DSMB) after reviewing the data. The study involved 3,900 volunteers ages 18 to 60 years in Europe, North America and South America.The experimental vaccine regimen was developed by Janssen. It was based on “mosaic” immunogens, featuring components from multiple HIV subtypes with the goal of inducing an immune response to a wide variety of global HIV strains.
During its scheduled data review, it became evident that there were no safety issues associated with the vaccine regimen; however, a comparison between the number of HIV infections seen in those who received the vaccine versus those who received a placebo revealed that they were equally prevalent.In order to ensure participant safety during the clinical trial, all participants were provided comprehensive HIV prevention tools including pre-exposure prophylaxis (PrEP). In addition to this precautionary measure, study staff monitored each participant’s progress closely and promptly referred any person who acquired HIV during the trial for medical care and treatment.
At this point in time all participants are being notified of these findings as further research is being conducted so as to gain a better understanding of why this clinical trial failed to deliver its desired outcome. It is possible that further analyses of the study data will provide further insight into what could be done differently with future similar studies.Janssen has expressed its commitment towards improving global public health and has vowed to continue investing resources into creating innovative healthcare solutions across various therapeutic areas including HIV/AIDS research and development. This includes an ongoing program devoted to continued progressive research surrounding various multi-subtype mosaic vaccines for prevention and treatment applications aimed at addressing unmet medical need for people living with HIV around the world.
The company also reaffirmed its dedication to the HIV research community and will continue to collaborate with other leaders in this field so as to develop potential new approaches for tackling one of the world’s most serious health issues. It is clear that this setback has not deterred Janssen from making a difference towards the global effort of achieving an HIV-free world.
Janssen has a long history of developing innovative therapies and remains committed to finding solutions for those living with, or at risk from, HIV. As the company looks to the future, it will continue to explore new strategies for tackling some of the biggest health challenges facing humanity today.
