The first clinical trial evaluating an investigational vaccine designed to protect against the novel coronavirus (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute in Seattle, according to the National Institutes of Health (NIH). 

Forty-five healthy adult volunteers between 18 and 55 years of age will be evaluated over the course of approximately 6 weeks, with the first participant receiving the investigational vaccine today. Different doses of the experimental vaccine will be analyzed for safety and the ability to induce an immune response in participants, according to the NIH.

The vaccine, named mRNA-1273, was developed by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) in collaboration with the biotechnology company Moderna, Inc. There are currently no approved vaccines that exist to prevent infection with SARS-CoV-2. 

“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, in a prepared statement. “This phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

Using the genetic platform messenger RNA (mRNA), the investigational vaccine is intended to direct the body’s cells to express a virus protein that researchers hope will elicit a robust immune response. This is the first trial to examine mRNA-1273 in humans, as it has only been previously tested in animal models. 

Prior studies that analyzed related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) were a major help to the scientists who created the quick turnaround of the mRNA-1273 vaccine, according to the NIH. Once the genetic information of SARS-CoV-2 became available, the scientists quickly selected a sequence to express the stabilized spike protein of the virus in the existing mRNA platform.

Study participants in the phase 1 trial will receive 2 doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be given a 25 microgram (mcg), 100 mcg, or 250 mcg dose at both vaccinations, with 15 people 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. Researchers will be reviewing safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before participants receive their second vaccinations. An additional safety review will be done before participants are enrolled in the 250 mcg cohort.

Participants will be asked to complete follow-up visits at the clinic between vaccinations and for additional visits across the span of a year after the second shot. Common vaccination symptoms and other medical issues will be monitored by clinicians. Participants will be asked to provide blood samples at specified time points for researchers to test in the laboratory to detect and measure the immune response to the experimental vaccine.

A protocol team will meet on a regular basis to review safety data and a safety monitoring committee will also periodically review trial data and advise NIAID.

REFERENCE
NIH clinical trial of investigational vaccine for COVID-19 begins. NIH.https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins. Published March 16, 2020. Accessed March 16, 2020.