New industry
partnership to accelerate research on flu vaccines for the elderly
Brown University
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,” Gravenstein said.
“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.”
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.”
“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.
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.
JILL
PIPHER Vice President for Research
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.
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.