Health Editor’s Note: Currently there is NO vaccine for COVID-19, (coronavirus disease 2109, Novel coronavirus 2019, SARS-CoV-2) as it is the first time this virus has been unleashed on the earth. No previous exposure equals no immunity what-so-ever. Today a clinical trial began to develop a vaccine with a volunteer receiving the first testing vaccine. Obviously COVID-19 is spread quite easily as the numbers of infected increase daily, all over the world. Initially cases of COVID-19 cropped up as travelers carried the virus to other parts of the world, Now the numbers of cases include viral spread in those who had not traveled, and are now spreading in communities by personal contact with the COVID-19 viral droplets ….Carol
NIH clinical trial of investigational vaccine for COVID-19 begins
National Institutes of Health
The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine.
The vaccine is called mRNA-1273 and was developed by NIAID scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said NIAID Director Anthony S. Fauci, M.D. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
Infection with SARS-CoV-2, the virus that causes COVID-19, can cause a mild to severe respiratory illness and include symptoms of fever, cough and shortness of breath. COVID-19 cases were first identified in December 2019 in Wuhan, Hubei Province, China. As of March 15, 2020, the World Health Organization (WHO) has reported 153,517 cases of COVID-19 and 5,735 deaths worldwide. More than 2,800 confirmed COVID-19 cases and 58 deaths have been reported in the United States as of March 15, according to the Centers for Disease Control and Prevention (CDC).
Currently, no approved vaccines exist to prevent infection with SARS-CoV-2.
The investigational vaccine was developed using a genetic platform called mRNA (messenger RNA). The investigational vaccine directs the body’s cells to express a virus protein that it is hoped will elicit a robust immune response. The mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans.
Scientists at NIAID’s Vaccine Research Center (VRC) and Moderna were able to quickly develop mRNA-1273 because of prior studies of related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Coronaviruses are spherical and have spikes protruding from their surface, giving the particles a crown-like appearance. The spike binds to human cells, allowing the virus to gain entry. VRC and Moderna scientists already were working on an investigational MERS vaccine targeting the spike, which provided a head start for developing a vaccine candidate to protect against COVID-19. Once the genetic information of SARS-CoV-2 became available, the scientists quickly selected a sequence to express the stabilized spike protein of the virus in the existing mRNA platform.
The Phase 1 trial is led by Lisa A. Jackson, M.D., senior investigator at KPWHRI. Study participants will receive two doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be assigned to receive a 25 microgram (mcg), 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort. The first four participants will receive one injection with the low dose, and the next four participants will receive the 100 mcg dose. Investigators will review safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250 mcg cohort.
Participants will be asked to return to the clinic for follow-up visits between vaccinations and for additional visits across the span of a year after the second shot. Clinicians will monitor participants for common vaccination symptoms, such as soreness at the injection site or fever as well as any other medical issues. A protocol team will meet regularly to review safety data, and a safety monitoring committee will also periodically review trial data and advise NIAID. Participants also will be asked to provide blood samples at specified time points, which investigators will test in the laboratory to detect and measure the immune response to the experimental vaccine.
“This work is critical to national efforts to respond to the threat of this emerging virus,” Dr. Jackson said. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”
Adults in the Seattle area who are interested in joining this study should visit https://corona.kpwashingtonresearch.org. For more information about the study, visit ClinicalTrials.gov and search identifier NCT04283461.
NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Adults in the Seattle area who are interested in joining this study should visit https://corona.kpwashingtonresearch.org/. People who live outside of this region will not be eligible to participate in this trial.
Carol graduated from Riverside White Cross School of Nursing in Columbus, Ohio and received her diploma as a registered nurse. She attended Bowling Green State University where she received a Bachelor of Arts Degree in History and Literature. She attended the University of Toledo, College of Nursing, and received a Master’s of Nursing Science Degree as an Educator.
She has traveled extensively, is a photographer, and writes on medical issues. Carol has three children RJ, Katherine, and Stephen – one daughter-in-law; Katie – two granddaughters; Isabella Marianna and Zoe Olivia – and one grandson, Alexander Paul. She also shares her life with her husband Gordon Duff, many cats, and two rescues.