Experimental COVID-19 Vaccine by Moderna Generates Immune Response
According to interim results published online today in the New England Journal of Medicine, mRNA-1273, an investigational vaccine designed to protect against SARS-CoV-2, was found to be generally well-tolerated and prompted neutralizing antibody activity in healthy adults.
The National Institute of Allergy and Infectious Diseases (NIAID) is supporting the ongoing Phase 1 trial. Researchers at Moderna, Inc. of Cambridge, Massachusetts, and NIAID are co-developing the experimental vaccine. The vaccine mRNA-1273 is being manufactured by Moderna and is designed to induce neutralizing antibodies directed at a portion of the coronavirus which the virus uses to bind to and enter human cells, the “spike” protein.
On March 16, in the trial led by Lisa A. Jackson, M.D., MPH, from Kaiser Permanente Washington Health Research Institute in Seattle, the vaccine candidate was received by the first participant. At the study sites in Seattle and at Emory University in Atlanta, the first 45 participants aged 18 to 55 years were enrolled and this interim report details the initial findings from them. The investigational vaccine of either 25, 100, or 250 micrograms (mcg) were given to three groups of 15 participants received two intramuscular injections, 28 days apart. 42
patients received both scheduled injections, while all the participants received one injection.The trial now has 120 participants as the trial was expanded to enroll adults older than age 55 years in April. However, the results of the 18 to 55-year age group are only covered in the newly published results.
There were no reports of serious adverse events, regarding safety concerns. Headache, fatigue, myalgia, chills, or pain at the injection site was reported by more than half of the participants. In those who received the highest vaccine dose, systemic adverse events were more common following the second vaccination. The doses used or planned for use in Phase 2 and 3 clinical trials of the investigational vaccine was according to the data on side effects and immune responses at various vaccine dosage.
The results of tests measuring levels of vaccine-induced neutralizing activity through day 43 after the second injection are also included in the interim analysis. High levels of neutralizing antibody activity were promoted by two doses of vaccine, and this level was above the average values seen in convalescent sera obtained from COVID-19 infected patients.
In late May, Moderna sponsored Phase 2 clinical trial of mRNA-1273 began enrollment. A Phase 3 efficacy trial is planned to be launched in July 2020.
Using the identifier NCT04283461, additional information about the Phase 1 clinical trial design is can be found at ClinicalTrials.gov.
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Safe experimental COVID-19 vaccine
