A Phase 1 clinical trial for an investigational COVID-19 vaccine is underway at Kaiser Permanente Washington Health Research Institute in Seattle.
The open-label trial plans to enroll 45 healthy adults aged 18 to 55 years over a six week period. The first study participant received the vaccine yesterday.
Researchers at Kaiser Permanente Washington Health Research Institute (KPWHRI) will evaluate different doses of the experimental vaccine for safety and its ability to induce immune responses. It is the first step in the clinical trial process to evaluating the benefit of a vaccine, according to the National Institutes of Health (NIH).
The vaccine, named mRNA-1273, was developed by National Institute of Allergy and Infectious Diseases (NIAID) scientists and collaborators at Moderna, Inc. in Cambridge, Mass.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” NIAID director Dr. Anthony Fauci said in a news 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 and Moderna developed mRNA-1273 using prior studies of related coronaviruses that can cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). The scientists used a genetic platform called mRNA to develop the investigation vaccine that direct’s the body’s cells to express a virus protein to elicit a robust immune response. The NIH says the vaccine has shown promise in animal models.
Study participants will receive two doses of the vaccine in an intramuscular injection in the upper arm, 28 days apart. Each participant will receive a 25 microgram (mcg), 100mcg or 250 mcg dose at both vaccinations and with 15 people in each dosage. The first four participants will receive the low dose and the next four participants will receive the 100 mcg dose. The researchers will then review the safety data before the remaining participants receive their 25 and 10mcg dose groups and before receiving second vaccinations.
Participants will return to the clinic between vaccinations for follow-up visits and additional visits across the span of a year after their second shot. Clinicians will continue to monitor the participants for symptoms and a protocol team will regularly meet to review safety data and review trial data.
“This work is critical to national efforts to respond to the threat of this emerging virus,” Dr. Lisa Jackson, senior investigator on the trial, said. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”
The clinical trial is funded by the NIAID, part of the National Institutes of Health. KPWHRI is part of the NIAID’s Infections Diseases Clinical Research Consortium. The Coalition for Epidemic Preparedness Innovations supported the manufacturing of the vaccine candidate for clinical trials.