Healthy patients in Seattle began receiving dosages Monday of the first potential Covid-19 vaccine to enter clinical trials, a substance developed partly by the Cambridge-based biotech Moderna.
The trial began at Kaiser Permanente Washington Health Research Institute in Seattle and will enroll 45 healthy adult volunteers who are 18 to 55 years old, according to the National Institute of Allergy and Infectious Diseases (NIAID), which is funding the trial. The institute is part of the National Institutes of Health.
Patients will be enrolled on a rolling basis, and the first phase of the trial will run about six weeks. This is the first of multiple steps in the clinical trial to evaluate the potential benefit of the vaccine.
Vaccine specialists say that it will be at least a year before any of the multiple vaccines in development by drug makers around the world could be deployed.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” Dr. Anthony Fauci, director of the federal infectious diseases institute, said, referring to the virus that causes Covid-19. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
The study is evaluating different doses of the experimental vaccine for safety and its ability to provoke an immune response in participants.
The vaccine relies on custom-built messenger RNA to produce an immune response. The experimental vaccine has shown promise in animal models, according to officials from NIAID and Moderna.
The vaccine, called mRNA-1273, was developed by NIAID scientists and Moderna. The Cambridge-based drug maker went public in December 2018 and raised $600 million in the largest initial public offering in biotech up to that point. The Coalition for Epidemic Preparedness Innovations, which is based on Oslo, also helped bankroll the vaccine effort.
Currently, there are no approved vaccines to prevent Covid-19.
Four study participants received the experimental vaccine on Monday, according to NIAID. Participants will receive two doses of the vaccine through an injection in the upper arm about 28 days apart. Each participant will be assigned to receive a dose of 25, 100, or 250 micrograms at both vaccinations, with 15 people in each dose cohort.
Participants will be asked to return to the clinic for follow-up visits between vaccinations and for additional visits across the span of a year after the second shot. They also will be asked to provide blood samples at specified intervals, which investigators will test in the laboratory to detect and measure the immune response to the experimental vaccine.
Coronaviruses are spherical and have spikes protruding from their surface, giving the particles a crown-like appearance. The spike binds to human cells, allowing the virus to gain entry.
The new coronavirus can cause a mild to severe respiratory illness and symptoms of fever, cough, and shortness of breath. Cases were first identified in December 2019 in Wuhan, China. As of Sunday, the World Health Organization had reported 153,517 cases of Covid-19 and 5,735 deaths worldwide. More than 2,800 confirmed cases and 58 deaths had been reported in the United States, according to the Centers for Disease Control and Prevention.
It took Moderna a mere 42 days to produce a few hundred vials of the experimental vaccine at the high-flying biotech’s $130 million plant in Norwood after the company received the genetic sequence of the virus from Chinese scientists.
Dr. Lisa A. Jackson, senior investigator at Kaiser Permanente Washington Health Research Institute, is leading the first phase of the trial.
“This work is critical to national efforts to respond to the threat of this emerging virus,” she said.
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