Phase 1 Trial of COVID-19 Vaccine Started Today

The first injections of an experimental vaccine against COVID-19 trial took place today in Seattle as part of a Phase 1 trial.

The National Institute of Allergy and Infectious Diseases (NIAID) website says that researchers hope to have initial data from the trial within three months. If the vaccine makes it out of the Phase 1 trial, larger trials involving hundreds to thousands of people will be needed, according to NIAID, and the vaccine will not be widely available for at least year and likely longer than that.

Anthony Fauci, MD, NIAID director, mentioned the first injection at the White House COVID-19 press conference this afternoon. The Associated Press reported earlier in the afternoon that the trial got today “with careful jabs in the arms" of four volunteers at the Kaiser Permanente Washington Research Institute in Seattle, and the wire service distributed a photo of one of the volunteers, Jennifer Haller, a 43-year-old Seattle resident.

The trial is designed to enroll 45 healthy adult volunteers between the ages of 18 and 55 who will be followed for a year to assess the vaccine’s safety and ability to spur an immune response that would fend off an infection with the new coronavirus.

The Seattle area has been one of the hotspots of the COVID-19 epidemic. The NIAID website says that the Kaiser Permanente Washington Research Institute was chosen as the site for the Phase 1 trial before there were any U.S. cases of the new coronavirus. Study volunteers will be screened and not enrolled if they have an active infection, the website says. 

The vaccine, dubbed mRNA-1273, was developed by NIAID scientists and collaborators at the Moderna (NASDAQ: MRNA), a biotech company in Cambridge, Massachusetts, according to a write-up of the trial posted on the NIAID website.

On a day when stock prices plummeted because of COVID-19 and large swathes of American life shutting down as a result, Moderna’s stock price shot up by 24.37%, closing at $26.49.

Scientists at NIAID’s Vaccine Research Center (VRC) and Moderna were able to develop the vaccine candidate relatively quickly because of previous studies of the coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), according to the NIAID.

A timeline on Moderna’s website says that Chinese authorities shared the sequence of SARS-CoV-12 on January 11 and that NIAID and Moderna scientist finalized the sequence of the vaccine just two days later. The “first clinical batch” was ready on February 7, according to the company timeline. It was tested before it was shipped to the NIH on February 24.

“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” Fauci was quoted as saying in the NIAID write-up. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

As described by NIAID, the Phase 1 trial is designed to include 45 study volunteers,who will receive receive two doses of the mRNA-1273 vaccine via intramuscular injection in the upper arm approximately 28 days apart. The volunteers are to be divided into three groups of 15, with one group scheduled to receive the 25 microgram (mcg) dose of the vaccine;  the second, the 100 mcg dose; and the third, the 250 mcg dose. The first four participants will receive one injection with the 25 mcg dose (presumably those are the four that AP reported on today) and the next four participants, the 100 mcg dose, according to the NIAID write-up. Investigators will then review safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before the initial sets of volunteers receive their second injections. Another safety review will be done before participants are enrolled in the 250 mcg cohort.

The study volunteers will be monitored for common reactiosn to vaccines, such as soreness at the injection site or fever. A protocol team will meet regularly to review safety data, and a safety monitoring committee will also periodically review trial data and advise NIAID, according to NIAID’s description. During the yearlong follow-up, blood samples will be collected at various times so investigators can test them for the presence of an immune response. 

The Phase 1 trial is being led by Lisa A. Jackson, MD, a senior investigator at the Kaiser Institute in Seattle.