PROVIDENCE – Lifespan Corp. began vaccinating volunteer participants this week as one of 110 host sites in the Phase 3 clinical trial for the Novavax Inc. vaccine against COVID-19.
Lifespan will help with the trial by signing up volunteers and giving them either the vaccine or the placebo, then tracking their responses over a two-year period and reporting that data, according to Dr. Timothy J. Babineau Jr., CEO and president of Lifespan.
For several months, Lifespan has been recruiting volunteers for the clinical trial through the National Institutes of Health network. The NIH, along with the U.S. Department of Health and Human Services, is funding the trial. The manufacturer is the Maryland-based pharmaceutical company, Novavax Inc.
“We know that as many effective vaccines as possible will be needed to beat the COVID-19 pandemic,” Babineau said Thursday, in announcing the trial participation. “This study is crucially important in that battle.”
The Lifespan trial site is among 110 participating in the U.S. and in Mexico. Altogether, the trial is seeking 30,000 participants who would be randomly assigned to either the vaccine developed by Novavax, or a placebo injection of saline. Neither the participants nor the people administering the vaccine would know which one the person was receiving, according to a news release describing the Phase 3 trial from the National Institutes of Health.
So far, 8,250 people are enrolled in the trial, said Dr. Karen Tashima, director of clinical trials at the Lifespan Immunology Center.
The trial seeks the participation of a racially and ethnically diverse group of volunteers, according to the NIH, with at least 25% being age 65 or older. The volunteers can be 18 and older. Two-thirds of the participants will get the vaccine, while one-third will get the placebo.
Like the two other vaccines, manufactured by Moderna Inc. and Pfizer Inc., that have already received emergency approval for use in the United States, the Novavax vaccine has a two-dose regimen. The first shot is followed about three weeks later by the second, Tashima said.
The purpose of the large-scale Phase 3 trial is to determine how effective the vaccine is and how safe, and participants will be monitored closely for the next two years, she said.
Vaccinations of the trial participants started this week, she said, based on a registry published by Lifespan and following a screening.
“We’ve been working for this moment over the past six months,” said Tashima.
In the earlier trials, she said, the vaccine appeared to produce the blood result, the antibodies, that researchers hoped to see, allowing it to move forward to a large, Phase 3 clinical trial. Sore arms, muscle aches and headaches were among the reactions.
Mary MacDonald is a staff writer for PBN. Contact her at macdonald@pbn.com.
