COVID-19 variant vaccine trial begins

An investigational vaccine designed to protect against the coronavirus variant first detected in South Africa was administered April 1 to 3 adult volunteers enrolled in a new phase 1 clinical trial at Kaiser Permanente Washington Health Research Institute. The trial officially launched March 31 with shots administered at another study site in Atlanta.

The vaccine was developed by the biotechnology firm Moderna. Led and funded by the National Institute of Allergy and Infectious Diseases, the trial is testing the immune response generated by the new vaccine candidate as well as its safety. Participants will return to the study clinic for follow-up visits and have their blood drawn. Scientists will use the samples to measure the immune response against different strains of the coronavirus. This phase of the trial will not determine whether the vaccine prevents infection by the new variant or stops its spread in the population.

“In a remarkably short period of time, scientists at Moderna and NIAID have created a new vaccine based on their previous vaccine, which is now being given to millions of people worldwide,” said Lisa A. Jackson, MD, MPH, a KPWHRI senior investigator who is overseeing the trial in Seattle. “As we advance this study in the coming weeks, it’s important to continue wearing masks, avoiding crowds, washing hands, and getting vaccinated when you can.”

Researchers aim to enroll approximately 210 healthy adult volunteers at KPWHRI, Emory University in Atlanta, and 2 other clinical research sites in the United States that are part of the NIAID-funded Infectious Diseases Clinical Research Consortium. This includes about 60 volunteers who received the original Moderna vaccine as a participant in NIAID’s phase 1 trial, as well as another 150 adults who have not received any COVID-19 vaccine. 

Suzanne Uvelli-Spencer, MD, a 76-year-old retired physician, is one of the volunteers who received her shot at KPWHRI the morning of April 1. “I find it really exciting that Kaiser Permanente has this study — it’s a great honor,” said Dr. Uvelli-Spencer, who had practiced for several decades in the Seattle area, including at Group Health, which is now Kaiser Permanente in Washington.

Investigators anticipate the trial will be fully enrolled by the end of April 2021. The results of this trial will help in the evaluation of vaccine strategies to combat variant strains of the coronavirus.