Researchers aim to enroll more than 200 adults to test Moderna’s COVID-19 vaccine designed to protest against a new coronavirus variant. Seattle is one of four cities participating in a new trial of an investigational COVID-19 vaccine that was developed by Moderna to protect people against a coronavirus variant first detected in South Africa.
The Phase 1 clinical trial, taking place at Kaiser Permanente Washington Health Research Institute (KPWHRI), is testing the immune response generated by the new vaccine candidate, as well as safety. The trial will not determine whether the vaccine prevents infection by the variant or stops its spread in the population, according to KPWHRI.
The B.1.351 SARS-CoV-2 variant first identified in the Republic of South Africa has been detected in at least nine states. As of April 1, at least 17 cases have been reported in Washington, according to the state Department of Health.
The first doses of the new vaccine were administered at KPWHRI April 1-3. Moderna’s new vaccine candidate includes “aspects of the variant that was first seen in South Africa,” which differs from the company’s vaccine already approved for emergency use by the U.S. Food and Drug Administration.
“In a remarkably short period of time, scientists at Moderna and (the National Institute of Allergy and Infectious Diseases) have created a new vaccine based on their previous vaccine, which is now being given to millions of people worldwide,” said Dr. Lisa A. Jackson, a KPWHRI senior investigator who is overseeing the trial.
Researchers aim to enroll approximately 210 healthy adult volunteers, including adults who’ve already received the original Moderna vaccine, as well as adults who have not.
“If it turns out that we ultimately do need an updated vaccine that’s more specifically targeted toward this variant, then the fact that we’re getting started on these studies right now means that the evaluation will be underway, [and] we will hopefully have a candidate vaccine kind of in the pipeline,” explained Dr. John Dunn of KPWHRI. “If it turns out that we need it, we’ll be able to get it up [and] ready.”
An independent safety monitoring committee will oversee the trial by regularly reviewing safety reports. Along with participants at KPWHRI, the Phase 1 clinical trial will also enroll participants at Emory University in Atlanta, Vanderbilt University Medical Center in Nashville, and Cincinnati Children’s Hospital Medical Center.