Investigational Mosaic HIV-1 Preventive Vaccine Enters its First Efficacy Study

The first efficacy study for an investigational mosaic HIV-1 preventive vaccine has been initiated by Janssen Pharmaceutical Companies and several global partners. Janssen parent company, Johnson & Johnson, together with the National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation are working to “advance the potential” of the global vaccine candidate, according to a press release from Johnson & Johnson, which will prevent a wide range of strains of the virus.

A total of 2600 women between the ages of 18 and 35 in 5 countries in sub-Saharan Africa will be enrolled in the large-scale proof-of-concept efficacy study, “Imbokodo” (HVTN 705/HPX2008), which will evaluate whether the investigational mosaic HIV-1 preventive vaccine is safe and able to reduce infection when compared with placebo. Clinical research sites in South Africa have already started administering vaccines to participants, and sites in Malawi, Mozambique, Zambia, and Zimbabwe, are still waiting on their regulatory approvals.

The initiation of this trial marks the first time in more than 10 years that 2 vaccine efficacy studies are occurring at the same time. According to J&J, the concurrent study HVTN 702 “is currently underway in South Africa to evaluate a different vaccine candidate.”

The quest for a vaccine against HIV has been a challenging one, partly because of the virus’ “ability to mutate rapidly and its global genetic diversity with multiple strains and subtypes prevalent in different parts of the world,” stated J&J in the press release. At the 2017 International AIDS Society conference, Contagion^® sat down with Hanneke Schuitemaker, PhD, vice president and head of viral vaccines discovery and translational medicine at Janssen Vaccines to learn more about these difficulties. A clip of her interview appears below:

Despite these complications, experts such as Anthony S. Fauci, MD, director of the NIH’s National Institute of Allergy and Infectious Diseases, have stated that we are not going to see an end to the AIDS epidemic without a vaccine. In a recent commentary, Dr. Fauci further elaborated on this, stating, “Although an estimated 19.5 million of the estimated 36.7 million HIV-infected people globally are receiving anti-HIV therapy (an extraordinary accomplishment), more than 17 million people are not receiving therapy. This leaves a substantial treatment gap.” In addition, he cited the sheer cost of providing antiretroviral therapy (ART) for all those infected as another factor to consider when thinking that the epidemic could be eradicated via therapy alone. “The cost of providing PrEP and other preventive services to the millions of people who are at risk for HIV infection is substantial,” he said. It is for these and several other reasons that Dr. Fauci feels that “we will actually need an HIV vaccine to achieve—and I want to underscore a very important word—a durable end to the HIV pandemic.”

The United Nation’s Program on HIV/AIDS (UNAIDS) has set a high bar [almost] end date for the epidemic with their 90-90-90 program which states that 90% of those living with HIV/AIDS will be aware of their status, 90% will be receiving antiretroviral therapy (ART), and 90% of those on ART will have viral suppression—all by 2020. And, while, many countries have made great strides toward reaching these goals, with an estimated 1.8 million individuals newly infected with the virus in 2016—790,000 of which were reported in eastern and southern Africa—much work is still needed to be done.

To this end, Johan Van Hoof, MD, Janssen Vaccines & Prevention B.V. and Therapeutic Area Head, R&D, Infectious Diseases & Vaccines stated in the press release that, “Having a preventive vaccine would be a vital tool in a comprehensive global strategy to end the HIV pandemic. Our investigational vaccine is based on mosaic antigens that have been engineered using genes from a wide range of different HIV subtypes. The ultimate goal is to deliver a ‘global vaccine’ that could be deployed in any geographic region to help protect vulnerable populations at risk of infection.”