NIH Launches Phase 1 Clinical Trial for COVID-19 Vaccine

March 17, 2020

The trial will enroll 45 health adult participants between the ages of 18 to 55 years of age over a 6-week period. The first trial participant received the investigation vaccine, mRNA-1273, today.

Could a vaccine for COVID-19 be on the horizon?

The National Institutes of Health (NIH) has announced that a phase 1 clinical trial evaluating an investigational vaccine candidate has launched in Seattle, Washington.

The trial will enroll 45 health adult participants between the ages of 18 to 55 years of age over a 6-week period. The first trial participant received the investigation vaccine, mRNA-1273, today.

The study investigators will look at different doses of the experimental vaccine and evaluate safety and efficacy in inducing an immune response in study participants.

Participants will receive 2 doses of the experimental vaccine via intramuscular injection into the upper arm approximately 28 days apart. The participants will be assigned to receive doses of 25 mcg, 100 mcg, or 250 mcg.

The first 4 study participants will receive the lowest dose, the following 4 will receive the 100mg dose. The investigators will review safety data prior to administering the second vaccination to the participants. The study team will also conduct a safety review prior to enrolling participants into the highest dose group.

As part of the investigation the participants will return to the clinic for follow-up visits between vaccinations and for additional visits in the year following the second vaccination. Common vaccination symptoms including injection-site pain and fever will be monitored. The study team will also request blood samples at specified time points from the participants to measure immune responses.

A protocol team will meet on a regular basis to evaluate safety data and a monitoring committee will also observe trial data.

The trial is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and is taking place that the Kaiser Permanente Washington Health Research Institute. The study will be led by Lisa A. Jackson, MD.

The investigational vaccine was developed by NIAID in collaboration with Moderna Inc. Vaccine manufacturing support for the clinical trials was given by the Coalition for Epidemic Preparedness Innovations.

According to a statement issued by the NIH, the vaccine candidate was developed quickly thanks in part to previous research on related coronaviruses including viruses that cause severe acute respiratory syndrome and Middle East respiratory syndrome (MERS).

Scientists with NIAID and Moderna were working on an investigational vaccine for MERS and were able to apply knowledge about coronaviruses to developing a SARS-CoV-2 vaccine candidate. When genetic information about the novel virus became available, the team selected a sequence to “express the stabilized spike protein of the virus into the existing mRNA platform.”

“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 NIAID said in the announcement. “This phase 1 study, launched in record speed, is an important first step toward achieving that goal.”