RIO DE JANEIRO, BRAZIL – American scientists started on Monday, March 16th, the first human trials of a potential vaccine against the new coronavirus. According to a statement by the National Institutes of Health (NIH), a body linked to the US government, stage 1 of clinical research involves 45 healthy adult volunteers, aged between 18 and 55. The first participant was administered the trial dosage yesterday.
Conducted by the Kaiser Permanente Washington Health Research Institute (KPWHRI) and NIH, the study will be conducted in Seattle, Washington State, the city most affected by the Covid-19 outbreak in the US.
According to data from the US government’s Centers for Disease Control, 708 infections with the new coronavirus have been confirmed in Washington alone. In the entire American territory, there are currently 3,487 people affected by Covid-19, of whom 68 have died.
Stage 1 of the potential vaccine study will assess the safety of the product and its ability to generate an immune response in volunteers.
Prior to testing in humans, the potential vaccine, called mRNA-1273, had shown a good response when tested in animals.
“The experimental vaccine was developed using a genetic platform called mRNA (messenger RNA). The experimental vaccine directs the body’s cells to produce a viral protein that is expected to cause a robust immune response. The mRNA-1273 vaccine has proven promising in animal models, and this is the first study to examine it in humans,” the NIH reported on its website.
Currently, there is no vaccine or specific treatment for the Covid-19. In most of those contaminated, the infection regresses spontaneously, with the response of the defense cells. In 20 percent of cases, however, patients’ conditions become severe, which usually requires intensive care (ICU) support.
Next steps
After stage 1, the potential immunizer is still required to undergo two further stages of human testing, in which the number of participants will be greater.
The vaccine application was developed by scientists at the National Institute of Allergy and Infectious Diseases at the Moderna biotechnology company in Cambridge, Massachusetts.
“Scientists were able to rapidly develop mRNA-1273 because of previous studies of related coronaviruses that cause Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS),” the NIH reported in a note. “Scientists were already working on research into a vaccine against MERS, which provided an advantage in the development of the Covid-19 vaccine,” they added.
In this first stage of the study, volunteers will be administered two shots of the vaccine through an intramuscular injection in the upper arm, with an interval of 28 days between doses. Volunteers will be divided into three groups and each will be administered with a different concentration: 25 mcg, 100 mcg, and 250 mcg.
The subjects will be followed for one year after the administration of the second dose. There is no estimate of when all stages of the test will be completed or when the vaccine will be available to the general public if it is successful.
Source: O Estado de S. Paulo