March 16 (UPI) – Initial tests of vaccines to protect against COVID-19 started on Monday, officials from the US National Institute of Health said.
Phase I clinical trials for vaccine evaluation are being conducted at the Kaiser Permanent Research Institute of Health in Seattle, with financial support from the National Institute of Allergy and Infectious Diseases NCDs.
NIH reported that the first patient received the vaccine on Monday, and 45 healthy adult volunteers will be included in the study over the next six weeks.
“Finding a safe and effective vaccine to prevent SARS-CoV-2 infection is an urgent public health concern,” said the NIAID Director. Anthony S. Fauci said in a statement. “This phase I study, launched at a record speed, is an important first step towards this goal.”
The vaccine, called mRNA-1273, was developed by NIAID scientists and their associates at Moderna, Inc., a biotechnology firm based in Cambridge, Mass., With the support of the Epidemic Preparedness Coalition. A recently launched study will evaluate different doses of an experimental vaccine for safety and its ability to elicit an immune response in participants.
The trial is the first of several steps in a clinical trial process to assess the potential benefits of the COVID-19 vaccine, a coronavirus that has affected more than 170,000 people in 127 countries. More than 6,000 people have died from the disease since its detection in late December in Wuhan, China.
In the United States, the Seattle area has so far been hit hardest by the global pandemic. There are currently no approved vaccines to prevent infection with COVID-19, and no proven antiviral drugs for its treatment.
Scientists at the NIAID and Moderne Vaccine Research Center were able to develop mRNA-1273 through preliminary studies of related coronaviruses that cause severe acute respiratory syndrome and respiratory syndrome in the Middle East. In fact, NIAID and Moderna have already worked on the MERS vaccine under study, and these efforts have given them the start of developing a candidate vaccine to protect against COVID-19.
Once the genetic information for the virus became available in January, scientists chose the sequence for the expression of the stabilized protein of the virus, which binds to human cells, in the existing mRNA platform. To date, the mRNA-1273 vaccine has already shown promising results in animal models, but this is the first test in humans.
In a study led by Dr. Lisa A. Jackson, a senior researcher at the Kaiser Permanente Washington Research Institute of Health, participants will receive two doses of the vaccine by intramuscular injection into the shoulder at intervals of about 28 days. Each participant will be assigned a dose of 25 micrograms, 100 micrograms or 250 micrograms for both vaccinations, 15 people in each dose cohort.
Researchers will examine safety data before vaccinating the remaining participants in dose groups of 25 and 100 mcg and before participants receive their second vaccinations. Another safety analysis will be done before participants are included in a 250 microgram cohort.
“This work is critical to national efforts to counter the threat of this new virus,” Jackson said in a statement. “We are ready to conduct this important trial thanks to our experience as a NIH clinical trial center since 2007.”
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