A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, WA, the United States National Institutes of Health announced in a March 16, 2019 press release. The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the NIH. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium.

The study is the first step of the clinical trial process, and it will evaluate different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately six weeks. The first participant received the investigational vaccine on March 16.

Currently, no approved vaccines exist to prevent infection with SARS-CoV-2, which is the virus that causes COVID-19. The investigational vaccine, developed by NIAID scientists and Moderna, is based on messenger RNA (mRNA) and has been named mRNA-1273. The mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial.

“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said NIAID Director Anthony S. Fauci, MD, in the press release. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

Scientists at NIAID’s Vaccine Research Center (VRC) and Moderna were able to quickly develop mRNA-1273 because of prior studies of related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). VRC and Moderna scientists were already working on an investigational MERS vaccine, which provided a head start for developing a vaccine candidate to protect against COVID-19.

“This work is critical to national efforts to respond to the threat of this emerging virus,” said study leader Lisa A. Jackson, MD, senior investigator at KPWHRI, in the press release. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”

Adults in the Seattle area who are interested in joining this study should visit https://corona.kpwashingtonresearch.org.

Source: NIH