Today marks an exciting milestone: the full enrollment of volunteers in the first efficacy study for Janssen’s investigational preventive HIV vaccine.
The Imbokodo study is designed to help researchers understand whether Janssen’s mosaic-based vaccine regimen is safe and able to reduce the risk of HIV infection. More than 20 Imbokodo clinical trial sites across five southern African countries have now successfully enrolled 2,600 women aged 18–35. The initial results from Imbokodo are expected by 2021.
Quest for a Global HIV Vaccine
One of the greatest challenges in the 35-year quest to find a vaccine has been the unique properties of the virus itself, including its ability to mutate rapidly and its global genetic diversity, with different HIV strains predominating in different parts of the world. HIV vaccines that produce immune responses against one subtype of HIV may not immediately work against another subtype.
The vaccine regimen being tested in the Imbokodo study uses cutting-edge technology that could help overcome this hurdle. It contains mosaic immunogens that have been created or engineered using genes from a wide variety of HIV strains. This is a step toward our goal of developing one global vaccine that could be used around the world to help protect people from HIV infection.
Women Moving Imbokodo Study Forward
Women and girls in the southern African countries, where the Imbokodo study is being conducted, experience high rates of HIV infection. In sub-Saharan Africa, three out of every four new HIV infections in young people aged 15 – 19 years occur in girls1. These numbers emphasize the urgency of finding solutions that meet the HIV prevention needs of females.
So Janssen decided to focus the Imbokodo study on women in this region. “Imbokodo,” the Zulu word for “rock,” is part of a well-known proverb in South Africa that refers to the strength of women and their importance in the community. The 2,600 women who have volunteered to participate in the study truly reflect the spirit of this concept by stepping up to help advance HIV vaccine research.
Partnerships for Faster Progress
Moving our mosaic vaccine into the Imbokodo study was only possible thanks to the support of a broad public-private partnership led by Janssen Vaccines & Prevention B.V., part of the Pharmaceutical Companies of Johnson & Johnson; the Bill & Melinda Gates Foundation; the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health; and the NIAID-funded HIV Vaccine Trials Network (HVTN).
Even more partners are supporting the study, including the U.S. Army Medical Materiel Development Activity (USAMMDA) and the Ragon Institute of Massachusetts General Hospital (MGH), Massachusetts Institute of Technology (MIT) and Harvard. The South African Medical Research Council is helping to implement the Imbokodo study in South Africa.
A New Optimism
The Imbokodo study has reached an important milestone. As it continues, we will need to work with our partners to conduct additional Phase 3 trials to test the vaccine’s efficacy and immunogenicity (ability to induce an immune response) in other populations and parts of the world. The good news is that these studies are already being planned.
Although we do have a long way to go, we are now more optimistic than ever that the world will find a preventive HIV vaccine in our lifetimes.
