COVID-19 Vaccine: US NIH Study On Experimental COVID-19 Vaccine mRNA-1273 Claims To Show Safe Immune Response
: The Phase 1 trial of an investigational vaccine, mRNA-1273, designed to protect against SARS-CoV-2, the virus that causes COVID-19 disease, was generally well tolerated and prompted neutralizing antibody activity in healthy adults, according to US NIH authorities.
The interim results of the trial were published yesterday in The New England Journal of Medicine
The currently ongoing Phase 1 trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine is being co-developed by researchers at NIAID and at Moderna, Inc. of Cambridge, Massachusetts. Manufactured by Moderna, 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.
The Phase 1 trial was led by Dr Lisa A. Jackson, M.D., MPH, of Kaiser Permanente Washington Health Research Institute in Seattle, where the first participant received the candidate vaccine on March 16.
This interim report details the initial findings from the first 45 participants ages 18 to 55 years enrolled at the study sites in Seattle and at Emory University in Atlanta. Three groups of 15 participants received two intramuscular injections, 28 days apart, of either 25, 100 or 250 micrograms (mcg) of the investigational vaccine. All the participants received one injection; 42 received both scheduled injections.
In mid-April, the trial was expanded to enroll adults older than age 55 years; it now has 120 participants. However, the newly published results cover the 18 to 55-year age group only.
Pertaining to safety, no serious adverse events were reported. More than half of the participants reported fatigue, headache, chills, myalgia or pain at the injection site. Systemic adverse events were more common following the second vaccination and in those who received the highest vaccine dose. Data on side effects and immune responses at various vaccine dosages informed the doses used or planned for use in the Phase 2 and 3 clinical trials of the investigational vaccine.
However in such trials, it is too early to say whether adverse effects as a result of Antibody-Dependent Enhancement (ADE) also known as disease enhancement or immune enhancement could occur. These dangerous adverse effects were known to occur in the past during vaccine developments for the SARS and MERS coronavirus diseases, which resulted in vaccine programs being halted then.
The detailed interim analysis includes results of tests measuring levels of vaccine-induced neutralizing activity through day 43 after the second injection. Two doses of vaccine prompted high levels of neutralizing antibody activity that were above the average values seen in convalescent sera obtained from persons with confirmed COVID-19 disease.
The Phase 2 clinical trial of mRNA-1273, sponsored by Moderna, began enrollment in late May. Plans are underway to launch a Phase 3 efficacy trial in late July 2020.
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