Phase 3 COVID-19 vaccine trial in Peoria

By TOM SCANLON
Foothills Focus Staff Writer

Hope Research Institute will conduct third-phase clinical trials on a potential COVID-19 vaccine in three Valley locations—including Peoria.

According to clinicaltrials.gov, a National Institutes of Health website that tracks trials, Hope Research Institute’s Peoria location on Thunderbird Road near the Loop 101 is one of 87 locations that will study Moderna’s mRNA-1273.

The Foothills Focus reached out to Moderna, asking if the company is soliciting volunteers in Peoria. At press time, no answer had been received.

On May 18, Moderna “announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).”

The Phase 1 trial was to determine safety in participants who received the potential vaccine.

According to a Moderna release, “mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies.”

On July 14, the NIH confirmed the first phase went well.

“An investigational vaccine, mRNA-1273, designed to protect against SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), was generally well tolerated and prompted neutralizing antibody activity in healthy adults, according to interim results published online today in The New England Journal of Medicine.”

According to the journal publication, the vaccine triggered an immune response with mild side effects—fatigue, chills, headache, muscle pain and pain at the injection site.

A subsequent Moderna press release stated the company is “on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.”

The first of 45 first-phase participants received the candidate vaccine in Seattle March 16.

A Phase 2 clinical trial of mRNA-1273 began enrollment in late May, according to NIH.

According to clinicaltrials.gov, the Phase 3 vaccine trial will be a “randomized, stratified, observer-blind, placebo-controlled study to evaluate the efficacy, safety and Immunogenicity of mRNA-1273 SARS-CoV-2 vaccine in adults aged 18 years and older. …

“The study is designed to primarily evaluate the efficacy, safety and immunogenicity of mRNA-1273 to prevent COVID-19 for up to two years after the second dose of mRNA-1273.”

An estimated 30,000 will participate in the trial, which will run from Monday, July 27, to October 27, 2022.

The trial is to include “Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.”

Those who are sick, pregnant or have had COVID-19 will not be allowed to participate in the trial.

According to its website, “Hope Research Institute works with investigators across multiple research areas. These investigators have extensive knowledge and training in their respected specialties. As a dedicated research site, HOPE coordinates studies in numerous indications to provide quality health solutions.”

For more information, visit clinicaltrials.gov.