The National Institute of Allergy and Infectious Diseases has sponsored an ongoing clinical trial for COVID-19 vaccine, an investigational vaccine called mRNA-1273, specifically designed to provide protection against SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). The vaccine has been reported to be generally well tolerated and prompted neutralizing antibody activity in healthy adults, according to preliminary results from phase 1 clinical trials, published in the New England Journal of Medicine.
An investigational #vaccine for SARS-CoV-2, the virus that causes #COVID19, was found to be well tolerated and generated immune response in a Phase1 #clinicaltrial sponsored by #NIH @NIAIDNews and @moderna_tx. Learn more https://t.co/Pn2pImdTAC
— NIH (@NIH) July 14, 2020
The research team at NAID and at Moderna, Inc. of Cambridge, Massachusetts, developed the vaccine together, manufactured by Moderna. The experimental vaccine, mRNA-1273 is designed in a way that it can neutralize the effect of antibodies that are directed at a portion of the coronavirus, “spike” protein, which the virus uses to bind to and enter human cells. The research was guided by Lisa A. Jackson, M.D., MPH, of Kaiser Permanente Washington Health Research Institute in Seattle, the primary place where the first participant received the candidate vaccine on March 16.
Promising news today in the search for a vaccine to protect against SARS-CoV-2, the virus that causes #COVID19. An experimental vaccine safely generated a robust immune response in healthy adults in an #NIH-sponsored Phase 1 trial. https://t.co/yHMFp8yMsW
— Francis S. Collins (@NIHDirector) July 15, 2020
Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles (yellow), isolated from a patient sample. The black area in the image is extracellular space between the cells. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Source: NIAIDThis research report explains that the details of the preliminary research findings, collected from the first 45 participants, average ages of 18 – 55 years, recruited in the study at Seattle and at Emory University in Atlanta. The 15 participants, divided into 3 groups, received 2 intramuscular injections, of either 25, 100 or 250 micrograms (mcg) of the investigational vaccine, with 28 days apart. All the participants received one injection; 42 received both scheduled injections. The Phase 1 clinical trial was expanded, tried to enroll participants with average age greater than 55, in April, resulting into 120 participants. Yet, the results that have been published included data obtained from participants of 18 to 55-year age group only.
The report shows that no serious adverse events were reported regarding the safety. Yet, over half of the participants reported fatigue, headache, chills, myalgia or pain at the site of injection. Following the second vaccination, systemic adverse events have been reported to be common, particularly in those participants who have had the highest vaccine dose. The research data regarding 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.
The data analysis shows that tests results that measure the vaccine level, particularly levels of vaccine-induced neutralizing activity through day 43 post the second injection. Two doses of vaccine stimulated the high levels of neutralizing antibody activity, that was reported to above the average values seen in convalescent sera obtained from persons with confirmed COVID-19 disease. The mRNA-1273 Phase 2 clinical trial, Moderna sponsored, has begun the selection in late May. Plans are preceding to launch a Phase 3 efficacy trial in July 2020.