Rutgers New Jersey Medical School Clinical Research Center represents the only clinical investigational site in New Jersey to participate in the Phase III HIV vaccine clinical trial known as MOSAICO. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, notes on this study, “While we are making encouraging progress in preventing new HIV infections, the development of a safe and effective HIV vaccine would be the ultimate game-changer.” Rutgers has developed an effective community engagement model for their research operation.
Each year in the United States alone, 35,000 new HIV infections occur. Occurring mostly in urban areas, about 13,000 people with AIDS in America die annually. Although great strides have been made in treating HIV—with improved treatments and better prophylaxis against opportunistic infections death rates have significantly declined. But problems persist and among African Americans rates are substantially higher. The CDC reports a total of over one million cases in America alone. Up to 44 million live with the virus globally, according to the World Health Organization (WHO).
Called MOSAICO, this Phase III study sponsored by Janssen (Johnson & Johnson) evaluates 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’s two arms include group #1 (experimental) that will receive the vaccine—Ad26.Mos4.HIV—via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 2 (preferably the deltoid of the non-dominant upper arm) and Ad26.Mos4.HIV together with Clade C and mosaic gp140HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection). While group #2 (placebo comparator) will receive placebo into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).
Involving 55 sites in multiple continents (North America, South America, Europe), Shobha Swaminathan, MD serves as Principal Investigator on behalf of Rutgers. Dr. Swaminathan recently noted, “We must do better because the prevention tool-box needs to be expanded for an AIDS free generation.”
Rutgers New Jersey Medical Center: Clinical Research Center
Rutgers clinical investigational group, also referred to locally by community activists from publications such as OutinJersey, fondly refer to the university’s research operation as “Research with a Heart” as they have led within the State of New Jersey the investigation into cutting-edge HIV therapeutics and prevention research for nearly 15 years. The site has been active working with the HIV community to offer advanced clinical research as care options.
An Important Model Developed at Rutgers for Community Research Engagement
Principal Investigator Swaminathan articulates the benefits of MOSAICO trial while Travis Love, Community Educator at Rutgers NJMS CRC conveys the study affords local communities noting, “We want people to understand we are Research with a Heart.” Love continued, “Although MOSAICO is one research study at our site, we also do treatment trials and we have a research community advisory board that meets monthly. It’s about moving the research forward.” Earlier in the year TrialSite News introduced the Rutgers Community Engagement Model as a means to offer cutting-edge research and science directly to a community significantly impacted by HIV. The Rutgers research operation involves a critically important role—the clinical research enter “community liaison”—whom interface with the community including study participants in inner-cities such as Newark.
Shobha Swaminathan, MD, Associate Professor Medicine