NIH begins clinical COVID-19 investigational vaccine trials

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NIH begins clinical COVID-19 investigational vaccine trials

By Sandra Levy - 03/16/2020

A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against COVID-19 has begun at Kaiser Permanente Washington Health Research Institute in Seattle. 

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, is funding the trial, which is open-label and will consist of 45 healthy adult volunteers aged from 18 to 55 years old and is expected to take approximately six weeks. The first participant received the investigational vaccine today.

By evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants, the study will consist of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine.

Called mRNA-1273, the vaccine was developed by NIAID scientists and their collaborators at the biotechnology company Moderna, based in Cambridge, Mass., and was supported in manufacturing by the Coalition for Epidemic Preparedness Innovations. 

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

The investigational vaccine was developed using a genetic platform called mRNA, or messenger RNA. The investigational vaccine directs the body’s cells to express a virus protein that it is hoped will elicit a robust immune response. The mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans.

Scientists at NIAID’s Vaccine Research Center and Moderna were able to quickly develop mRNA-1273 because of prior studies of related coronaviruses that cause severe acute respiratory syndrome, and Middle East respiratory syndrome. 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 targeting the spike, which provided a head start for developing a vaccine candidate to protect against COVID-19. 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.

The Phase 1 trial is led by Lisa Jackson, a senior investigator at KPWHRI. 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 a 25 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 a low dose, and the next four participants will receive the 100 mcg dose. Investigators 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.

Participants will be 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. Clinicians will monitor participants for common vaccination symptoms, such as soreness at the injection site or fever as well as any other medical issues. A protocol team will meet regularly to review safety data, and a safety monitoring committee will also periodically review trial data and advise NIAID. Participants also will be asked to provide blood samples at specified time points, which investigators will test in the laboratory to detect and measure the immune response 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.”

Adults in the Seattle area who are interested in joining this study should visit https://corona.kpwashingtonresearch.org. For more information about the study, visit ClinicalTrials.gov and search identifier NCT04283461.