With support from a three-year $2.1 million agreement with Insight Therapeutics, a private company that focuses on the health care of older adults, a team of Brown University public health researchers will look to identify the most effective flu vaccines for elderly nursing home residents.
As people get older, the risk of developing serious flu-related complications increases. Of the tens of thousands of U.S. residents who die from influenza each year, some 80 to 90% are age 65 or older, said Stefan Gravenstein, principal investigator of the research at Brown, a professor of medicine at the Warren Alpert Medical School and of health services, policy and practice at the School of Public Health.
Gravenstein said the study will compare two licensed, safe and effective vaccines -- an egg-free recombinant flu vaccine and a traditional flu vaccine where seasonal influenza viruses are mass-produced in chicken eggs and then inactivated -- in up to 1,000 nursing homes each in this and the next flu season.
Nursing homes are a particularly useful environment to conduct research because the people there are older and more vulnerable. When you have something that is out there for public use, like all of the vaccines involved in our studies, it's important to figure out which interventions help this especially frail population most in clinically meaningful ways, such as keeping them out of the hospital."
Stefan Gravenstein, principal investigator of the research, Brown University
A recombinant vaccine is made up of just specific influenza proteins that trigger an immune response and can be mass-produced in lab-grown cells. Gravenstein said the team will test the hypothesis that the recombinant vaccine will be more effective at protecting residents with these specific proteins than the larger variety of proteins in vaccines produced in chicken eggs.
The agreement is a part of a partnership between Brown and Insight Therapeutics -- a Virginia-based company that specializes in clinical research involving older adults as well as professional medical education and health communications -- and Sanofi Pasteur, a French pharmaceutical company that produces vaccines against infectious diseases such as influenza, tetanus and rabies.
The sponsored research partnership comes as Brown continues to expand its relationships with corporate and industry partners through its Office of Industry Engagement and Commercial Venturing.
Jill Pipher, vice president for research at Brown and professor of mathematics, said it reflects Brown's broader dedication to advancing relationships with private industry.
"This research agreement with Insight Therapeutics to improve health care is a substantial contribution to Brown's efforts to tackle the urgent problems of society through faculty discoveries," Pipher said. "The project is also an important part of Brown's commitment to increase its work with private industry, as well as with public and nonprofit partners, to build significant commercial endeavors that address real-world issues."
Brown's other initiatives to create new collaborations include the newly launched riHub accelerator based in Providence and the Brown Biomedical Innovations to Impact fund, which supports the development of biomedical technologies into commercial products.
The new research will build on a foundation of previous work in which Gravenstein and Insight Therapeutics cofounders Ed Davidson and Lisa Han have compared the effectiveness of different flu vaccines, such as high-dose vs. standard-dose vaccines, in nursing homes. Gravenstein said that the partnership between Brown, Insight Therapeutics and Sanofi has strong potential for several reasons.
"There are three parts to this: efficiency, scale and clinical relevance," Gravenstein said. "Brown has the infrastructure and intellectual resources to look not just at large datasets but large data that is specific to long-term care."
While clinical trials typically recruit individual participants for studies, which is costly in terms of time and money, this study will include entire nursing homes that agree to offer one of these vaccines for their standard of care. Both vaccines are available, licensed and recommended by national guidelines as options to meet this care standard, Gravenstein noted.
"Insight Therapeutics welcomes the partnership with Brown," Davidson said. "Our knowledge of the long-term care environment at the ground level meshes well with Brown's intellectual resources and provides an efficient platform for large-scale trials like this one."
The team will use Medicare claims data and a dataset that measures quality of care at nursing homes on a quarterly basis to track the long-term outcomes after offering one of the two vaccines to their residents. Those outcomes will include, for example, residents being hospitalized for respiratory illnesses, or for any reason, for at least two years following vaccination.
Gravenstein said the study design will allow the team to efficiently study tens of thousands of elderly individuals in nursing homes -- a clinically relevant context. Getting answers about the comparative effectiveness of different flu vaccines can inform public health decision-making, he said.
Sanofi Pasteur is providing funding to Insight for the seasonal supply of the study flu vaccines for residents and staff in all participating nursing homes. Gravenstein said Sanofi will have no role in the study design or the analysis of the data -- the company will play a role similar to that of the federal government in federally funded research.
The Brown research team also includes Vince Mor, Issa Dahabreh, Pedro Gozalo, Nina Joyce, Kevin McConeghy, Patience Moyo, Orestis Panagiotou, Theresa Shireman and Andrew Zullo, primarily in the Center for Gerontology and Health Care Research; and David Canaday and Elie Saade, both at Case Western Reserve University.