Tuesday, September 29, 2020
A phase 1 trial of a probe mRNA vaccine to prevent SARS-CoV-2 infection showed that the vaccine is well tolerated and induces a strong immune response in older adults. A report published today in New England Journal of Medicine Describes the findings of the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.
Experimental Vaccine, mRNA-1273, NIAID and Moderna, Inc. of Cambridge, Massachusetts. Was co-developed by K researchers. Phase I trials began on March 16, 2020 and were extended to recruit older adults approximately one month later. Older adults are more susceptible to complications of COVID-19 and are an important population for vaccination. Understanding how the vaccine affects older adults is an important part of measuring its safety and efficacy.
The trial was performed at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, Emory University in Atlanta and the NIAID’s Vaccine Research Center (VRC) clinic at the NIH Clinical Center in Bethesda, Maryland. Julie Lagerwood, DO, Deputy Director and Chief Medical Officer at VRC, NIH oversees the study on site. Alliance Epidemic Preparedness Innovations (CEPI) supported the creation of a vaccine candidate for this trial. The trial is supported by the Clinical Research Consortium for Infectious Diseases (IDCRC) through NIAID.
In its expansion to include older adults, the trial included 40 healthy volunteers: 20 adults age 56 to 70 and 20 adults age 71 and older. Ten volunteers in each age group received low doses (25 μg) of the vaccine, and 10 volunteers in each age group received high doses (100 μg). After about a month, the volunteers received a second dose of the same vaccine at the same dose. During the study, volunteers participated in visits to the clinic to track their reactions to the vaccine and assess safety.
Overall, the researchers found that the discovered vaccine was well tolerated at this old age. Although some volunteers experienced some transient adverse effects, including fever and fatigue after vaccination, the researchers found that they demonstrated a good immune response to the vaccine: strong against SARS-COV-2 in the blood of vaccinated volunteers Binding and neutralizing antibodies were included. Importantly, the immune response to the vaccine seen in older volunteers was comparable to that observed in younger age groups.
The study of older volunteers will continue for approximately one year after the second vaccination to monitor the long-term effects of the vaccine. According to the researchers, these Phase 1 trials support the screening of the vaccine in older adults in a larger Phase 3 trial.
For more information about the test, see NIAID’s March 16 press release, NIAID’s March 27 statement, or visit clinicaltrails.gov and search identifier NCT 04,283461.
Anderson and others. Safety and immunity of the SARS-CoV-2 mRNA-1273 vaccine in older adults. New England Journal of Medicine DOI: 10.1056 / NEJMoa2028436 (2020).
Dr. John Begel, Associate Director of Clinical Research in NIAID’s Division of Microbiology and Infectious Diseases, and Deputy Director of NIAID’s Vaccine Research Center, Drs. Barney Graham is available for comment.
NIAID supports and supports research at NIH, across the United States, and around the world – to study the causes of infectious and immune-mediated diseases, and to develop better tools to prevent, diagnose and treat these diseases for. News releases, fact sheets and other NIAID related material are available on the NIAID website.
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