NYU Grossman School of Medicine is enrolling participants in a randomized Phase 3 clinical trial to determine the safety and efficacy of the COVID-19 vaccine candidate developed by the pharmaceutical company AstraZeneca.
The trial will seek to enroll up to 30,000 healthy study participants aged 18 years and older to receive two doses of either the vaccine or a placebo (saline solution).
Vaccine designers at the company and Oxford University sought to determine which protein components of SARS-CoV-2, the current pandemic virus, are “most noticed by” the human immune system. Successful vaccine ingredients “teach” the immune system which microbial invaders to attack upon future encounters, providing protection for a period of time, researchers say.
“This trial represents the advance of yet another kind of potential vaccine into large-scale trials, and we will need a variety of approaches if we are to control this terrible pandemic,” says Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center at NYU Langone Health.
Five research clinics within NYU Langone Health will vaccinate study participants, with the Vaccine Center at NYU Langone’s Tisch Hospital in Manhattan coordinating the effort.
Other system hospitals that will serve as vaccinating sites include NYU Langone Hospital—Brooklyn and NYU Langone Hospital—Long Island (formerly known as NYU Winthrop Hospital).
Research clinics at two NYU Grossman School of Medicine-affiliated institutions, NYC Health + Hospitals | Bellevue in Manhattan and VA New York Harbor Healthcare System, are also conducting the trial.
NYU Langone Health is one of only 10 specialized NIH-funded Vaccine and Treatment Evaluation Units (VTEUs) in the nation, several of which are participating in the AstraZeneca COVID-19 vaccine trial.
As a VTEU, NYU Langone is part of the COVID-19 Prevention Network (CoVPN), supported by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health.
The COVID-19 Prevention Network is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.
Cold Virus as Vehicle
The COVID-19 vaccine in the newly launched trial uses a virus that causes colds in chimpanzees but not humans. It delivers into patient’s cells a gene that instructs them to make the “spike proteins” used by SARS-CoV-2 to attach to proteins on human cell surfaces, the first step in invading cells. Including the spikes in vaccines has the potential to make proteins required for viral survival (ability to infect) visible to the human immune system, say the study investigators.
Studies so far have shown that this viral protein triggers a strong immune response, with the body manufacturing proteins called antibodies that glom onto and inactivate the protein, and that label it for destruction by immune cells (e.g., T cells).
In an earlier, smaller study focused on the vaccine’s safety, and recently published in The Lancet, the study vaccine, called ChAdOx1 nCoV-19, demonstrated the ability to generate in more than 91 percent of vaccinated study participants SARS-CoV-2 “neutralizing antibodies,” capable of defending cells from the virus, and of blocking its biological effects.
The earlier study also found that study participants receiving the vaccine candidate, also called AZD1222, had mild, flu-like symptoms as side effects, and the vaccine was safe and generally well tolerated.
Current trial participants will receive either two doses of AZD1222 or saline solution as a control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline. The health of patients will be monitored for two years after their second dose of the vaccine candidate.
Investigators at NYU Grossman School of Medicine and the affiliated clinics are currently seeking to enroll study participants at higher risk for COVID-19 infection and disease, including older adults, racial and ethnic minorities who have been disproportionately affected by COVID-19 (e.g. blacks, latinx, and indigenous peoples), and workers with certain occupations like first responders/restaurant and bar staff, and other essential workers.
To join the trial registry of potentially interested participants, please visit http://nyulmc.org/covidvaccine.
The trial is funded by the Biomedical Advanced Development Authority (BARDA) within the U.S. Department of Health and Human Services (HHS), and by NIAID.