A study based in Seattle has been enrolling healthy adults for a clinical trial testing an investigational vaccine to stem the devastation caused by the spread of SARS-CoV-2. Phase 1 of the clinical trial has begun with the first participant receiving the novel vaccine today as scientists hope to assess its efficacy and safety for use in the wider population.
The trial is being funded by The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, based at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. As an open trial both the researchers and participants will know what dosage of the vaccine they have administered. Participants will receive two injections of the vaccine around 28 days apart, with each participant being assigned either a 25 microgram (mcg), 100 mcg or 250 mcg dose in both instances.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” NIAID Director Anthony S. Fauci, M.D said in a statement. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
There is currently no vaccine for SARS-CoV-2, the pathogen that causes the disease COVID-19, with patients presenting with mild to severe respiratory illness. Vaccines are a safe way of delivering a small dose of a pathogen in the form of antigens into an individual's bloodstream. The introduction triggers an immune response resulting in antibodies that serve as memories of the pathogen. When the person then transmits the same pathogen, the body is prepared with antibodies to fight off the illness before it takes hold. If a safe and effective vaccine for SARS-CoV-2 can be developed, it would prevent deaths in vulnerable populations by effectively giving their immune systems a trial-run of the disease, making them better able to fight it off and escape severe symptoms should they contract it.
The trial in Seattle will enroll 45 healthy volunteers aged 18 to 55 years old testing them over a period of around 6 weeks. Developed by NIAID scientists in collaboration with Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, the vaccine is called mRNA-1273 and has been supported by The Coalition for Epidemic Preparedness Innovations (CEPI) for the Phase 1 clinical trial.
The vaccine builds upon a genetic platform called mRNA (messenger RNA) which effectively translates genetic codes, signaling the synthesis of a protein. The mRNA-1273 vaccine has been found to trigger cells to express a virus protein that elicits a robust immune response in animal models, but this is the first opportunity researchers have had to examine the response in humans.
The vaccine’s production is built on existing research into the structure of related coronaviruses including SARS and MERS. Once the team of scientists was able to access genetic information about the SARS-CoV-2 pathogen, they could quickly build upon their understanding that the spiked structure of coronaviruses is what enables them to gain entry to human cells and work on targeting this as a means of protection. This method for vaccination was already being investigated by scientists at NIAID’s Vaccine Research Centre and Moderna attempting to synthesize a prophylactic means of treatment for MERS.
While a pivotal moment in the fight against SARS-CoV-2, this clinical trial is the first step of many before it will be deemed safe for wider distribution and it could be some time before mRNA-1273 is approved for use. If you’re interested in joining this study, are aged between 18 and 55, have no pre-existing medical conditions and live in the Seattle area visit corona.kpwashingtonresearch.org to find out how you can get involved.