A Phase 1 clinical trial evaluating an investigational vaccine developed to protect against coronavirus disease 2019 (COVID-19) began on Monday March 16, 2020, at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, according to a press release from the National Institutes of Health (NIH). The first participant received the investigational vaccine on Monday.
The open label trial will enroll 45 healthy adult volunteers aged 19 to 55 years over approximately 6 weeks. The research is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
“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 NIH release. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal."
The vaccine, currently called mRNA-1273, was co-developed by NIAID scientists and collaborators at Moderna, Inc, a biotech company based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial. The investigational vaccine has shown promise in animal models.
The rapid development of mRNA-1273 has in part relied on previous studies of related corona viruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Scientists at NIAID's Vaccine Research Center (VRC) and Moderna already were working on an investigational MERS vaccine and were able to move quickly as soon as the genetic information of SARS-CoV-2 became available.
Study participants are to receive 2 vaccine doses via intramuscular injection in the upper arm 28 days apart. Three cohorts of 15 participants each will be assigned to receive a 25, 100, or 250 mcg dose at both vaccinations. The first 4 participants will receive 1 injection with the low dose, and the next 4 will receive the 100 mcg dose. Safety data will be reviewed before the remaining participants in the 25 and 100 mcg dose groups are vaccinated and before participants receive their second vaccinations. Another safety review will be peformed before participants are enrolled in the 250 mcg cohort.
Participants will be asked to return to the clinic for follow-up visits between vaccinations and for additional visits for 1 year after the second shot. They will be monitored for common vaccination adverse events and asked to provide blood samples at specified points to be evaluated for immune response.
“This work is critical to national efforts to respond to the threat of this emerging virus,” said Dr. Jackson. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”
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