A phase 1 trial of an experimental mNR vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well tolerated and generates a strong immune reaction in the elderly. A report published today in the New England Journal of Medicine describes the effects of the study, which was supported through the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.
The experimental vaccine, mRN-1273, evolved together through researchers from NIAID and Moderna, Inc. from Cambridge, Massachusetts. The Phase 1 trial began on March 16, 2020 and expanded to recruit seniors about a month later. Older adults are more vulnerable to COVID-19 headaches and are a vital population for vaccination. Understanding how the vaccine affects older adults is an essential component in measuring its protection and efficacy.
The trial conducted at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, Emory University in Atlanta and the NIAID Vaccine Research Center (VRC) clinic at the NIH Clinical Center in Bethesda, Maryland. Julie Ledgerwood, DO, Deputy Director and Medical Director of the VRC, oversaw the exam on the NIH website. The Coalition for Innovations in Epidemic Preparedness (CEPI) supported the manufacture of the candidate vaccine for this trial. through NIAID.
In extension for older adults, the trial recruited 40 healthy volunteers: 20 adults over 56 to 70 and 20 adults over 71. Ten volunteers in the organization by age won a lower dose of the vaccine (25 g) and 10 volunteers from The Age Organization won a higher dose (100 g). After about a month, volunteers received a moment dose of the same vaccine at the same dose. Throughout the study, volunteers attended clinical visits to monitor their responses to the vaccine and assess safety.
In general, researchers found that the experimental vaccine was well tolerated in this older group. Although some volunteers experienced brief side effects, adding fever and fatigue after vaccination, the researchers found that they also had a smart immune reaction to the vaccine: the blood of vaccinated volunteers contained physically powerful neutralizing and binding antibodies opposed to SARS-CoV-2, most importantly, the immune reaction to the vaccine observed in older volunteers comparable to that observed in younger age groups.
The test will continue to be applied to older volunteers for approximately one year after vaccination to monitor the long-term effects of the vaccine. According to the researchers, these effects of the Phase 1 trial of additional experimental vaccine tests in the elderly in a giant phase 3 test underway.
For more main points on the trial, refer to the NIAID press release on March 16, the NIAID on March 27, or stop at ClinicalTrials. gov and look for identification NCT04283461.
Anderson and cabbage. Safety and immunogenicity of the mNSA-1273 vaccine for SARS-CoV-2 in the elderly. New England Journal of Medicine DOI: 10. 1056 / NEJMoa2028436 (2020).
Dr. John Beigel, Associate Director of Clinical Research in the Division of Microbiology and Infectious Diseases at NIAID, and Dr. Barney Graham, Deputy Director of the NIAID Vaccine Research Center, will be available for comment.
NIAID conducts and supports studies, in NIH, the United States and around the world, to examine the reasons for infectious and immunomediated diseases and to expand broader tactics to prevent, diagnose and treat infectious and immunomediated diseases. Press releases, fact sheets and other materials similar to NIAID can be obtained on the NIAID website.
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