Clinical trial of COVID-19 vaccine begins
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A phase 1 clinical trial to assess an investigational vaccine for COVID-19 has begun at Kaiser Permanente Washington Health Research Institute in Seattle, according to an NIH news release.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, said in a news release. “This phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
The vaccine, which is named mRNA-1273, was administered to the first study participant today. The full open-label trial will enroll 45 healthy adult volunteers aged 18 to 55 years for approximately 6 weeks. Researchers from NIAID and biotechnology company Moderna, Inc. worked in tandem to develop the candidate. There are currently no approved vaccines for COVID-19.
“This work is critical to national efforts to respond to the threat of this emerging virus,” Lisa A. Jackson, MD, senior investigator at Kaiser Permanente Washington Health Research Institute, said in the release. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”
Researchers developed the vaccine using mRNA. The vaccine directs the body’s cells to express a virus protein to produce an immune response. mRNA-1273 has previously shown promising results in animal models. Prior studies of similar coronaviruses that can cause SARS and MERS aided researchers in the new vaccine’s development.
Study participants will return to a clinic for follow-up visits between vaccinations over the course of a year following their second shot, which is given approximately 28 days after the first, according to the release. They will be monitored by clinicians for common vaccination symptoms, including soreness at the injection site and fever, as well as other medical concerns. Participants will also provide blood samples at specified time points to help investigators measure immune response to the vaccine.
“This is the defining global health crisis of our time,” WHO Director-General Tedros Adhanom Ghebreyesus, PhD, MSc, said at a press conference this morning. “The days, weeks and months ahead will be a test of our resolve.” – by Eamon Dreisbach