Washington: Four healthy volunteers received a dose of an experimental coronavirus vaccine as the first human trial has started in the US. The trial to evaluate a candidate vaccine against the newly identified virus is taking place at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The vaccine was developed by US National Institutes of Health (NIH) scientists and collaborators at biotechnology company Moderna Inc., based in Cambridge, Massachusetts.
A 43-year-old mother-of-two from Seattle became the first patient to receive the jab on Monday, March 17 2020, reported the BBC News, quoting news agency Associated Press. The researchers plan to enroll 45 participants ages 18 to 55 years in the trial. Experts say the trial will take many months to determine the safety of the vaccine, as well as whether it can trigger an immune response in volunteers. According to the researchers, the vaccine, dubbed mRNA-1273, cannot cause the coronavirus disease but contains a harmless genetic code copied from the virus that triggered the COVID-19.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” NIAID Director Dr Anthony Fauci said in a NIAID statement, published March 16. Dr Frauci said this Phase 1 study, which was launched in record speed, is an important first step toward achieving that goal.
So, what is a ‘Phase 1’ trial?
For a new drug to be deemed safe and effective for widespread use, it must pass through three iterative phases of clinical trials. This means, if the initial tests go well, it may take at least 18 months before the vaccine becomes available for public use.
Basically, the phase 1 trial evaluates the safety and toxicity of a vaccine at different dose levels, as well as determines drug pharmacokinetics. The main purpose of the phase 1 clinical trial is to provide information about how the vaccine interacts with a healthy human body, according to the US Food and Drug Administration (FDA). During the first trial, the researchers will examine a small group of people, typically between 20 and 80 individuals, who would be administered different doses of an experimental treatment.
The phase 1 trial is led by Lisa A Jackson, M.D., senior investigator at KPWHRIl. The volunteers will be given two jabs into the upper arm muscle in total, with a 28-day gap between doses. Each participant will 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 a 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,” said a news release by NIH.
The researchers will, over the course of a 14-month period, monitor how each person metabolises the given treatment and what common side effects emerge in response to different doses, LiveScience reported.
As per the US Centers for Disease Control and Prevention (CDC), after the phase 1 trial, the drug must then be tested in larger groups of people and over longer periods of time, in Phase 2 and Phase 3 trials.
Currently, there’s no approved vaccine exists that can help prevent infection with the coronavirus, which has claimed at least 7,007 lives and infected more than 175,530 people across the world. But, researchers around the world are working on various treatments to help combat the spread of the deadly virus which has triggered a global pandemic.