Clinical Trial Launched for Investigational COVID-19 Vaccine

A clinical trial evaluating an investigational vaccine for the 2019 novel coronavirus, SARS-CoV-2, has been launched, with volunteers receiving the first injection on Monday, March 16, Kaiser Permanente Washington Health Research Institute reported.¹

This is the first trial to be launched in humans for a vaccine for this virus, which caused COVID-19, according to Kaiser Permanente. At the start of the trial, 4 volunteer participants were injected.¹

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is funding the trial.

The phase 1 federally sponsored study involves 45 volunteer participants and is evaluating the investigational vaccine called mRNA-1273, developed by Moderna, over a 6-week period. In this phase of the study, Kaiser Permanente researchers are testing the safety of various doses and whether these doses produce an immune response. Study participants include healthy adults age 18 to 55 years old living in the Seattle, Washington area. To be eligible, participants must not have certain health conditions that affect the immune system and can’t be taking any medications that affect the immune system.²

According to the NIH, participants will receive 2 doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be assigned to receive a 25 microgram (mcg), 100 mcg, or 250 mcg dose at both vaccinations, with 15 individuals in each dose cohort. The first 4 participants will receive 1 injection with the low dose, and the next 4 participants will receive the 100 mcg dose. The researchers will review safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250 mcg cohort.²

Participants will be monitored through follow-up visits between vaccinations and additional visits across the span of a year after the second vaccination.²

Modern previously worked with the NIH on a vaccine for MERS-CoV, according to the company.³ The current investigational vaccine for SARS-CoV-2 was developed using a genetic platform called messenger RNA (mRNA). The vaccine works by directing the body’s cells to express a virus protein that it is hoped will elicit a robust immune response, according to the NIH. The mRNA-1273 vaccine has previously shown promise in animal models.²

“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” Anthony S. Fauci, MD, director of the NIAID, said in a statement.² “This phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

References:

1. Kaiser Permanente launches first coronavirus vaccine trial [news release]. Kaiser Permanente Washington Health Research Institutes’ website. https://www.kpwashingtonresearch.org/news-and-events/recent-news/news-2020/kaiser-permanente-launches-coronavirus-vaccine-study-seattle. Accessed March 16, 2020.

2. NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins [news release]. https://www.niaid.nih.gov/news-events/nih-clinical-trial-investigational-vaccine-covid-19-begins. Accessed March 16, 2020.

3. Moderna’s Work on a Potential Vaccine Against COVID-19 [news release]. https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19. Accessed March 16, 2020.