Rutgers New Jersey Medical School (NJMS) Clinical Research Center is the only research site in the State of New Jersey participating in a worldwide effort to enroll 3,800 HIV negative individuals in the first Phase III HIV vaccine efficacy trial conducted in more than a decade.
According to a report in Rutgers Today, Rutgers New Jersey Medical School (NJMS) Clinical Research Center (NJMS) prepares to participate in this important clinical trial. Shobha Swaminathan, an associate professor of medicine and site leader for the National Institutes of Health (NIH) funded trial notes, “We are the only New Jersey site participating in the study, and its great that we are able to bring this effort to Essex and Hudson counties.”
The study’s sponsor, Janssen Vaccines & Prevention B.V. (part of Janssen which is an operating company of Johnson & Johnson) has organized a global consortium—constituting a joint venture of NIH, the HIV Vaccine Trials Network and Janssen Pharmaceuticals—seeking to recruit 50 to 100 from greater Newark area with the goal of developing a vaccine that will provide HIV immunity for life.
Although overall rates of HIV/AIDS have decreased, the risks of infections within certain populations continues to surge putting many people at grave danger. Young men who have sex with men and transgender people, especially those between the ages of 13-34 represent a high-risk population. For example, in the United States, gay and bisexual men account for two-thirds of new HIV diagnoses despite the fact that they represent only 4% of the population according to some estimates. Moreover, although preventative medicine called PrEP can stop new cases, it must be consumed daily as a pill, which is a challenge for some, especially those with financial issues and unstable housing—this demographic segment can struggle with following strict regimens and includes vulnerable minority populations.
Called Mosaico, this study has been designed by sponsor Janssen to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and /or transgender individuals. The study teams seek a total of 3,800 patients while the study runs till June 23, 2023. Including the HIV Vaccine Trials Network, the consortium will work with 57 research sites.
Participants in this study will have regular medical care and HIV testing at each center including NJMS, thus benefiting them personally, while helping to progress scientific and clinical research.
Previous Study Shows Promising Results
Last year Johnson & Johnson announced promising results from a Phase I/2 program based on the Mosaic-based HIV preventive vaccine regimen. Known as the ASCENT study, they sponsor found that adding a bivalent soluble protein to the regimen (a combination of Clade C and Mosaic gp140) improved the breadth of immune responses to different HIV strains circulating worldwide. They shared the results at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City. This study found that bivalent gp140 enhanced immune responses to Clade B, the predominant subtype in the Americas, Western Europe, and Australasia. The sponsor reported that this feat precluded the diminishing of immune responses to Clade C, which is prevalent in Southern Africa, the horn of Africa and India.
The Experimental Vaccine
The joint venture is seeking improved treatment options for vulnerable populations. The Janssen Mosaic-based vaccine candidate contains mosaic immunogens (molecules capable of inducing an immune response) that have been created using genes from a wide variety of HIV-1 subtypes with the goal of delivering a global vaccine that could be deployed anywhere in the world, reported Johnson & Johnson last year.
Ad26.Mos4.HIV is a tetravalent vaccine composed of Ad26.Mos1.Gag-Pol, Ad26.Mos2.Gag-Pol, Ad26.Mos1.Env, and Ad26.Mos2S.Env. Clade C and Mosaic gp140 HIV bivalent vaccine contains: Clade C gp140, HIV-1 Env gp140 of Clade C, Mosaic gp140, HIV-1 Env gp140, and aluminum phosphate adjuvant. The Sponsor reports that sufficient evidence reveals that a combination of vaccination with Ad26.Mos.HIV followed by Ad26.Mos.HIV together with Clade C gp140 protein in aluminum phosphate adjuvant led to highest level of protection observed so far with this vaccine concept.
The mosaic-based regimen utilizes Janssen’s Advac® adenovirus vector platform and PER.C6® production cell line technology. An elite group of high-powered organizations have come together to support this work, including the following:
· Bill & Melinda Gates Foundation
· The U.S. Military HIV Research Program (MHRP) at Walter Reed Army Institute of Research along with the Henry M. Jackson Foundation for the Advancement of Military Medicine
· Ragon Institute of Massachusetts General Hospital
· Massachusetts Institute of Technology (MIT) and Harvard
· Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School
· International AIDS Vaccine Initiative (IAVI)
Since 2005, Johnson & Johnson reports that Janssen Vaccines & Prevention B.V. has participated as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under a number of grants led by Principal Investigator Dan Barouch.
Community Participation via NJMS: The Heart of Newark
With NJMS’ entry into the Mosaico study, the site’s main clinical research center, in Newark, offers cutting-edge clinical research and science directly to a community significantly impacted by HIV. NJMS at the research center in Newark introduces a critically important role—the clinical research center “community liaison”—which interface with the community including study participants.
In Newark, NJMS employs Travis Love, reports Rutgers Today. Dedicated and engaged, Love and Tuten are able to develop rapport, respect and trust with prospective study participants. It is difficult enough to recruit patients for clinical trials generally and specifically—in the inner-city context with large African American and Latino populations such as in Newark—even more difficult. Hence, for these liaisons, it isn’t just an office job. Individuals such as Love and Tuten participate in community events and engage with community members in such a successful way that their work received a North Jersey Community Research Initiative award in 2019—the Newark PROUD Award. Lead investigator for NJMS, Swaminathan commented for Rutgers Today that “this long-standing community-based relationship will help recruit Mosaico volunteers.”
Janssen/Johnson & Johnson Works to Make History
The company has been at the forefront of developing advanced vaccines targeting HIV. Why? Well, the company believes HIV is one of the world’s greatest challenges with 36.7 million people around the world living with HIV and more than 2 million infected each year.
Lead investigator for NJMS for the Mosaico trial
Shobha Swaminathan, an associate professor
Call to Action: Interested in HIV research? This is an important study—Mosaico—to monitor.