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Our Mission to Develop a Global HIV Prevention Tool

Mosaico: Our Mission to Develop a Global HIV Prevention Tool


This week marks the 10th International AIDS Society (IAS) Conference on HIV Science (IAS 2019). In the run up to the conference, Janssen was proud to announce plans for the Mosaico study, the first phase 3 trial of our investigational HIV vaccine.

To reflect on this development are two of the leaders of Janssen’s HIV vaccine effort, Maria Grazia Pau, Senior Director, Compound Development Team Leader for HIV Vaccine Programs and Sabrina Spinosa Guzman, Director of Clinical Development for Mosaico.

How important is the HIV Vaccine Program at Janssen, and where does Mosaico fit into that?

Maria: The quest for a preventive vaccine began the moment HIV was identified as the cause of AIDS 35 years ago. Historically however, it has been a major challenge for scientists to identify an effective vaccine due to the unique properties of the virus – including the proliferation of multiple different HIV strains around the world.

In recent years, Janssen and its partners have been making real progress in HIV vaccine research and it is definitely a top priority for the company. Our goal is to develop a global vaccine that could be used anywhere to prevent infections from different HIV strains. We hope to achieve this through an investigational mosaic-based vaccine regimen. The “Mosaico” study (also known as HPX3002/HVTN 706) is due to start later this year. It will break new ground in being the first phase 3 efficacy trial – and largest study ever – for Janssen’s vaccine candidate. Mosaico will have a target enrollment of 3,800 men who have sex with men (MSM) and transgender people in eight countries across North America, South America and Europe.

What is a mosaic vaccine and how does it work?

Sabrina: A mosaic vaccine contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of HIV-1 subtypes. The goal is to trigger a robust and durable immune response, so the vaccine regimen is administered through four vaccinations over one year, and the specific vaccine components are varied for the last two vaccinations.

How do you tackle the challenge of launching a global study like this?

Sabrina: Working to end a global epidemic isn’t something that any one organization can do alone. Mosaico will take place across three continents, eight countries and more than 55 clinical trial sites. Something this big takes a village and we’re thrilled to be part of a robust partnership to make it happen. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN) based at the Fred Hutchinson Cancer Research Center, and the U.S. Army Medical Research and Development Command (USAMRDC) are joining forces with Janssen to advance the potential global vaccine.

Mosaico will become the second efficacy study for the mosaic vaccine. What’s happening with the first efficacy study, Imbokodo?

Maria: We reached an important milestone with Imbokodo in May, when we successfully enrolled all study volunteers – in fact we now have 2,637 young women participating in the trial across five southern African countries. So, if things progress well, we should be on track to see initial findings from Imbokodo in late 2021, and we hope to see data from Mosaico in 2023. We have an exciting few years ahead as we wait for these important results.

What news will Janssen have at IAS 2019?

Sabrina: In addition to sharing more details about Mosaico with the HIV community, we will be presenting important clinical results for mosaic vaccines from two earlier-stage studies. One of these (called ASCENT) was the first to test the specific mosaic regimen that will be evaluated in Mosaico, and the results are very encouraging. The other (called APPROACH) is also encouraging because it suggests our mosaic vaccines can create a long-lasting immune response to HIV.

Do you think we will achieve an HIV vaccine in our lifetime?

Maria: There’s definitely a new optimism in the field. Our clinical program is progressing well, and there are other important vaccine studies going on, including HVTN 702 (also known as “Uhambo”) which is sponsored by NIH and is taking place in South Africa.

We will have to see how all of these studies, including our own, progress. But it does feel like we are getting closer to our ultimate goal of achieving an HIV vaccine.