Clinical Trial for COVID-19 Vaccine Begins in Seattle

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Close-Up Of Cropped Hands Inserting Syringe Into Vial
[Daniel Chetroni / EyeEm, Getty Images]

Seattle has been on the frontlines of the COVID-19 pandemic, and has just launched the first NIH clinical trial of a vaccine treatment on healthy adult volunteers.

The vaccine itself is called mRNA-1273, and it was developed by NIAID scientists and collaborators at the biotechnology company Moderna in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate.

Currently, no approved vaccines exist to prevent infection with SARS-CoV-2, so the launch of this clinical trial is a giant step in the fight against its spread throughout the world.

This Phase I clinical trial plans to evaluate different dosages of the experimental vaccine to determine safety limits and ability to induce an immune response in participants. If the phase I trial is successful and the vaccine behaves well, it will be the first of multiple clinical trial phases to evaluate the potential benefit of this vaccine.

The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine yesterday, which is designed to protect against coronavirus disease 2019 (COVID-19), and the trial is being conducted out of Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.

This Phase 1 trial is led by Lisa A. Jackson, M.D., a senior investigator at KPWHRI, and her study participants will receive two doses of the vaccine via intramuscular injection in the upper arm, approximately 28 days apart. Each participant will be assigned to receive either a 25 microgram (mcg), 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort. The first four participants will receive one injection with the low dose, and the next four participants will receive the 100 mcg dose, etc., with a safety assessment will be conducted before the highest dosage is given.

Participants will be monitored and asked to return to the clinic for follow-up visits between vaccinations and for additional visits across the span of a year after the second shot.  Participants will be monitored for common vaccination symptoms, and a protocol team will meet regularly to review safety data and advise NIAID. Participants will also provide blood samples at specified time points to measure and detect immune responses to the experimental vaccine.

“This work is critical to national efforts to respond to the threat of this emerging virus,” Jackson said. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”

“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, M.D., in a posting on the NIH website. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium.

This investigational vaccine was developed using mRNA (messenger RNA), a novel vaccine source. The mRNA vaccine directs cells to express a viral protein on the cell surface, in the hope that this expression will elicit a robust immune response. The mRNA-1273 vaccine has shown promise in animal models, but this is the first trial to examine it in humans.

Scientists at NIAID’s Vaccine Research Center (VRC) and Moderna quickly developed mRNA-1273 due to their experience and prior studies with related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

Coronaviruses are spherical and have spikes protruding from their surface, giving the particles a crown-like appearance. The spike binds to human cells, allowing the virus to gain entry. VRC and Moderna scientists already were working on an investigational MERS vaccine that targets the spike, and provided a head start in developing a vaccine candidate to protect against COVID-19. Once the genetic information for SARS-CoV-2 was online, scientists could quickly selected a sequence to express the stabilized spike protein of the virus on the existing mRNA platform.

SARS-CoV-2 infection results in COVID-19, and can cause a mild to severe respiratory illness, including fever, cough and shortness of breath symptoms. COVID-19 cases were first identified in December 2019 in Wuhan, Hubei Province, China. As of March 15, 2020, the World Health Organization (WHO) has reported 153,517 cases of COVID-19 and 5,735 deaths worldwide. More than 2,800 confirmed COVID-19 cases and 58 deaths have been reported in the United States as of March 15, according to the Centers for Disease Control and Prevention (CDC).

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