Hackensack Meridian Health, New Jersey’s largest and most comprehensive health network which treated more COVID-19 patients than any other health system in the state, is now enrolling individuals in a COVID-19 vaccine clinical trial.
The national COVE Trial aims to study the mRNA-1273 vaccine, co-developed by Moderna and the NIH, in 30,000 individuals. Hackensack University Medical Center, the network’s flag ship academic medical center, is one of the nearly 90 sites around the country assessing its safety and effectiveness.
“Hackensack Meridian Health has been at the forefront of delivering innovative breakthroughs in the pandemic and offering high-quality compassionate care in the most challenging circumstances,’’ said Robert C. Garrett, FACHE, chief executive officer of Hackensack Meridian Health. “We are proud to support the development of a vaccine to fight this global menace.’’
“Our health network has been involved in virtually every facet of COVID-19 research,” said Ihor Sawczuk, M.D., FACS, president of Hackensack Meridian Health‘s Northern Market, and the chief research officer of the network. “We’re eager to do our part with vaccines, which have such enormous potential for millions of people.”
The SARS-COV2 virus binds to the human cells via its spike protein, causing the viral fusion and cell entry that leads to infection. This novel vaccine candidate aims to capitalize on that spike protein. The vaccine uses a messenger RNA (mRNA) delivery system. The vaccine is expected to trigger the immune system to mount a response by encoding for a protein that targets against the binding receptor on the spike protein (the antibodies) and also stimulates the host T cells to clear the infection quicker. If the person who is vaccinated then gets exposed to the SARS CoV-2 virus, the immune system could potentially quickly recognize the virus and be able to prevent, and/or lessen, the intensity of the disease.
The vaccines being tested are made from the genetic code of the virus copied from SARS-CoV-2, not the whole virus. Therefore, the vaccines cannot cause infection or cause COVID-19 illness. This is a phase III study to test the safety and efficacy of the vaccine.
Hackensack Meridian Health investigators expect to enroll 300 individuals. These individuals are required to be older than 18 years of age, must not be pregnant or breast feeding, must not have had the SARS-CoV2 infection (COVID-19), and must not have some conditions like certain bleeding disorders, active infection or other immune disorders. The randomization of the groups will be stratified based on age and risk factors.
Members of diverse communities are especially sought, to ensure the enrollment group is representative of a wide variety of people – in order to understand how it works in different groups, especially those at highest risk for COVID-19.
Those anonymously selected will receive two injections in the arm muscle, 28 days apart. Half of the enrolled patients will receive the vaccine, and the other half will receive a placebo as part of the randomized blinded, Phase III trial. Safety calls will be made and electronic diaries will be given to the subjects, to monitor for adverse events, and to surveil for COVID-19 infection. Anyone who does become infected with COVID-19-like illness will be assessed further with lab tests and will be assisted in getting care with their primary care provider, who will be given the results.
“We are eager to be a part of this very crucial and important work,” said Bindu Balani, M.D., senior attending physician at Hackensack University Medical Center’s Division of Infectious Diseases, and a faculty physician at Hackensack Meridian School of Medicine. “I think social distancing and doing the due diligence of personal protection is very important throughout this pandemic but this study has the opportunity of being one of the solutions to this pressing issue.
“Vaccine studies will work if vaccinations occur and we thank the volunteers in advance for being a part of this important research,” Balani added.
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