The first phase of a Covid-19 vaccine trial at Emory University and other locations produced “very encouraging” results, according to trial investigators.
The experimental vaccine manufactured by Moderna Inc., mRNA-1293, produced “a good immune response,” and trial participants suffered no serious adverse events, according to results presented Tuesday afternoon by Emory reseachers and published at the same time on the New England Journal of Medicine website.
mRNA-1273 is designed to induce neutralizing antibodies directed at a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells, according to Emory.
The vaccine trial’s second phase, sponsored by Moderna, began enrollment in late May and is continuing. Plans are underway to launch a large phase 3 efficacy trial this month.
The initial phase of the clinical trial studied the effects of the vaccine in three different doses — 25 micrograms, 100 micrograms and 250 micrograms — on 45 individuals ages 18-55, Dr. Nadine Rouphael, contact principal investigator at the Emory Vaccine and Treatment Evaluation Unit (VTEU). Rouphael is also interim director of the Hope Clinic at the Emory Vaccine Center and associate professor of medicine (infectious diseases) at Emory University School of Medicine.
“It had shown that the vaccine was well-tolerated. It has also shown that the vaccine is able to produce a good immune response,” Rouphael said in a press briefing Tuesday.
“These interim results are very encouraging,” Dr. Evan Anderson, principal investigator for the trial at Emory and associate professor of medicine and pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta, said in a statement.
“While there is still a lot of work to do before we have a vaccine that is proven to be safe and effective against COVID-19, this study provides critical information about the safety of the vaccine. Importantly, the vaccine resulted in a robust immune response,” Anderson said.
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He and Rouphael are coauthors of the study published in the New England Journal of Medicine.
The interim analysis includes results of tests measuring levels of vaccine-induced neutralizing activity through day 43 after the second injection, according to Emory’s statement. Two doses of vaccine prompted high levels of neutralizing antibody activity that were above the average values seen in blood samples taken from convalescent Covid-19 patients.
No serious adverse events were reported, investigators said. Side effects including fatigue, headache, chills, myalgia and pain at the injection site were reported by more than half of the volunteers, with systemic adverse events being more common following the second vaccination and in those who received the highest vaccine dose, they said.
Phase 1 of the trial began on March 16. mRNA-1273, developed by the National Institute of Allergy and Infectious Diseases (NIAID) and Moderna Inc., was the first of around 120 potential vaccines to be tested in the United States. Seventeen of the 45 participants were enrolled at Emory. In addition to the age range, eligible participants could not have chronic diseases or health conditions that affect the immune system, and couldn’t be taking immunosuppressive medications.
About a month after the trial’s start, investigators expanded Phase 1 of the trial to enroll 60 additional participants over age 55: 30 aged 56-70 and 30 ages 71 and older. The trial was also expanded to a third site, the NIAID Vaccine Research Center clinic at the National Institutes of Health Clinical Center in Bethesda, Md. The Kaiser Permanente Washington Health Research Institute in Seattle was the other initial trial study site besides Emory’s VTEU.
Phase 1 trial participants received two shots of the experimental vaccine approximately one month apart and were being followed for about one year.