Affiliated with Brown University, Rhode Island Hospitals and Health Services also known as Lifespan now seeks to enroll volunteers for the Phase 3 Novavax COVID-19 vaccine trial. One of 115 trial site centers in the U.S. and Mexico, the Rhode Island health care organization started participation in December. Apparently, 8,250 people have already received the vaccine or a placebo, including nine to date from Lifespan. The hope here at Lifespan is that enrollment for the study can accelerate. The overall study must enroll 30,000.
Dr. Fauci Praises the Study
As reported in the Providence Journal, Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases “praised the trial” back in December in an NIH press release. He commented, “The launch of this study—the fifth of government, academia, industry and the community” would help address the “unprecedented health crisis of COVID-19.”
The fifth such Phase 3 vaccine trial showcases the unprecedented effort to take on and overcome COVID-19.
As reported in the Providence Journal, the sponsor (Novavax) backing this study (NCT04611802) seeks those participants that are aged 18 and up and hopefully Lifespan can involves a diversified range of participants for the study—that is those most affected by the virus as well as participation from the elderly to those with co-morbidities such as diabetes).
With specific diversity goals, they sponsor hopes that at least a quarter of the study are elderly while 15% of the total should be African American; 10 to 20% Hispanic and 1% to 2% Native American. As TrialSite has chronicled, the elderly, minority groups and many lower income to middle income whites have been hit hard by the pandemic.
Lifespan decided to develop a participant registry in late summer. The registry can be accessed here.
The Academic Health Care System
Lifespan is part of an academic healthcare system, which could bring advantages to the effort—given its access to large amounts of researchers and patients, commented Lifespan president and CEO Timothy J. Babineau. Dr. Karen Tashima directs clinical trials for the Lifespan Immunology Center and Michael Henderson serves as Vice President of Research who told the local media the Novavax trial was “exciting.”
Lifespan actually represents Rhode Island’s first and largest health system. Founded in 1994 by Rhode Island Hospital and The Miriam Hospital, the not-for-profit system has emerged as a comprehensive, integrated, academic health system affiliated with the Warren Alpert Medical School of Brown University. They also partner with various divisions from Rhode Island Hospital.
A major research hub, at any given time, Lifespan has 1,500 current clinical studies underway. During the most recent year, Lifespan funded $92 million in grants and contracts evidencing the creativity, ingenuity and importance of the biomedical and behavioral research ongoing at Lifespan. The research effort here supports about 357 faculty engaged in studies supported by 610 research staff.
Call to Action: If you are based in Rhode Island, consider volunteering for the Novavax study.