In late July, Vanderbilt University Medical Center (VUMC) will begin recruiting up to 1,000 volunteers in a late-stage study of an experimental COVID-19 vaccine developed by Moderna Inc. in collaboration with the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.
The randomized, placebo-controlled Phase 3 trial will be open to people 18 years old and older. They will receive two shots of either the vaccine or an inactive placebo and will be followed for two years.
The goals of the study are to determine how effective the vaccine is in protecting against COVID-19 and how long the protection lasts. For more information, contact [email protected] or [email protected]
“Vaccine development around COVID-19 is moving at an unprecedented pace due to the remarkable partnerships between academic institutions, the NIH and pharmaceutical industry leaders,” said Buddy Creech, MD, MPH, principal investigator of the NIH-funded Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU).
“We are pressing full speed ahead to provide an answer to this pandemic, while also taking the necessary steps to ensure that new vaccines and therapeutic drugs are both safe and effective,” said Creech, also associate professor of Pediatric Infectious Diseases and director of the Vanderbilt Vaccine Research Program.
The study will be conducted through the VTEU and Vanderbilt’s HIV Vaccine Trials Unit Clinical Research Site, part of the HIV Vaccine Trials Network (HVTN). Spyros Kalams, MD, associate professor of Medicine and Pathology, Microbiology and Immunology, is the HVTN principal investigator.
VUMC is one of several U.S. centers participating in the nationwide Phase 3 trial, which will enroll 30,000 volunteers over the next two months, officials said.
VTEU and HVTN sites are part of the NIAID-supported COVID-19 Prevention Network (CoVPN), which will harness the resources and expertise of national research networks to rapidly evaluate COVID-19 prevention strategies.
“This massive effort to rapidly and safely test COVID-19 vaccines takes advantage of these existing networks, each with multiple clinical research sites and great deal of vaccine and immunology expertise,” Kalams explained.
The Moderna mRNA vaccine contains genetic material from the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19. The spike protein enables the virus to bind and fuse with the membrane of certain types of cells in the body, the first step in infection.
VUMC researchers provided laboratory support of a Phase 1 trial of the vaccine in 45 healthy adults. According to a report published Tuesday in The New England Journal of Medicine, the vaccine had no safety concerns and induced anti-SARS-CoV-2 immune responses in all participants.
A Phase 2 study to further evaluate the safety of the vaccine and its ability to elicit an immune response is currently underway in healthy adults.
The Vanderbilt study has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services and the Vanderbilt Vaccine and Treatment Evaluation Unit (VTEU) Cooperative Agreement/Grant numbers 1UM1 AI148452-01 and AI148452-01S3.
The Vanderbilt HIV Clinical Trials Unit is supported by NIH grants 5UM1AI069439-15 and 3UM1AI069439-15S1.