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Phase 1 Clinical Trial for Coronavirus Vaccine Begins in Seattle
This is the first clinical trial that will test an investigational coronavirus vaccine on human study participants.
Phase 1 clinical trials for a coronavirus vaccine have begun at Kaiser Permanente Washington Health Research Institute (KPWHR) has begun, according to a statement from the National Institutes of Health.
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The investigational vaccination, funded in part by the National Institute of Allergy and Infectious Disease, began today by administering the first immunization to a healthy adult between ages 18 and 55 years old. In total, the phase 1 clinical trial will enroll 45 adults who fit this criteria and investigate outcomes over a six-week test period.
The phase 1 clinical trial will specifically look at the safety of different vaccine dosages as well as the immune response that the vaccine, called mRNA-1273, elicits in study participants.
“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. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
The vaccine uses messenger RNA, or mRNA, which should cause the body’s cells to express a virus protein. In doing so, it should elicit a massive immune response in the human body. Thus far, the vaccine has shown promise in animal tests. This clinical trial is the first test on human participants.
This human study will look at the effects of different vaccine dosages. Study participants will be assigned to receive either a 25 or a 100 microgram dose over the course of two vaccination sessions, each timed at 28 days apart. Between doses, study leaders will continuously assess the safety of certain dosages.
“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. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”