magine an HIV-free world.
It's a bold vision that is closer to reality following the announcement last week in the lead-up to the 2019 International AIDS Society Conference on HIV Science that Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and its partners will embark on the next phase of testing a promising investigational preventive HIV vaccine.
Set to kick off later this year, the Mosaico trial will be the second efficacy study to test Janssen’s mosaic-based vaccine concept, which is designed with the goal of protecting against a wide range of HIV-1 strains that are responsible for the epidemic around the world. The first proof-of-concept efficacy study is the ongoing Phase 2b clinical trial known as Imbokodo, which is evaluating the vaccine regimen among 2,600 young women across five countries in southern Africa.
What makes this new trial different? Mosaico, a Phase 3 efficacy study, will evaluate the vaccine regimen in men who have sex with men (MSM) and transgender people aged 18-60. It aims to recruit 3,800 participants at approximately 55 clinical trial sites across North America, South America and Europe—making it Janssen’s largest study to date for the vaccine.
“The MSM and transgender communities face a lot of discrimination around the world, specifically in Latin America,” says Jorge Sanchez, M.D., M.P.H., co-founder of the Asociación Civil Impacta Salud y Educación (“Impacta”) and current Vice President of the Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales (CITBM), which are both part of the global HIV Vaccine Trials Network (HVTN) and among five Mosaico study sites in Peru. “The situation has improved over the past 20 years, but accessing preventive medicine is still an issue for these communities. Participating in an HIV vaccine trial is a way to say, ‘we are here.' ”
Initial results from Mosaico are expected in 2023, and from Imbokodo in 2021.
We need armies of people to help make it happen. People in the sciences, people in clinical centers to execute these trials and volunteers—especially volunteers. I’m so impressed with the people who are helping move human health forward.Share
Having worked to define and prioritize these trials, , Vice President and Global Head, Viral Vaccine Discovery and Translational Medicine, Janssen Vaccines & Prevention B.V., is pragmatic about the long road ahead.
“You have to be very patient in this field because you need time for enrollment, the study vaccination regimen is administered over a year, and then you need to allow for sufficient follow-up time to see if the vaccine has an impact on HIV infection," she says. "Staggering these trials in parallel to one another will help us, should we get a positive result, act more quickly to bring a vaccine to the world and help prevent the further spread of the epidemic.”
In addition to patience, the historic challenge of finding an HIV vaccine also requires global collaboration. “This is an opportunity for public health officials, pharmaceutical companies, government officials and researchers to work together for the good of humanity, to show that we can actually make a difference,” says Sanchez, who together with Schuitemaker is optimistic that the world could achieve an HIV vaccine in their lifetime.
Of course, nothing would be possible without volunteer enrollment. Imbokodo achieved full enrollment in May, right on schedule, and Sanchez and Schuitemaker are hopeful that Mosaico will follow suit.
“We need armies of people to help make it happen,” Schuitemaker says. “People in the sciences, people in clinical centers to execute these trials and volunteers—especially volunteers. I’m so impressed with the people who are helping move human health forward.”
Watch this video to learn more from Hanneke Schuitemaker about her team’s exciting and emotional journey to discover a possible preventive vaccine for HIV: