UCSD Health and a section of UCSD School of Medicine is aiding in a national clinical trial to test the effectiveness of a new vaccine to protect against SARS-CoV-2, the novel coronavirus that causes COVID-19.
The trial, sponsored by the National Institutes of Health's newly formed COVID-19 Prevention Network, is based on a vaccine prototype developed by Moderna, a pharmaceutical company located in Massachusetts. The trial is began Monday at UCSD Health, UCSD's Altman Clinical and Translational Research Institute and various other locations throughout the country.
"A vaccine is desperately needed to help control the epidemic," said Dr. Stephen Spector, professor of pediatrics at UC San Diego School of Medicine and principal investigator for the UCSD arm of the vaccine trial. "We are excited that UC San Diego will be able to offer the San Diego community the opportunity to participate in a Phase III vaccine trial that, if successful, has the potential to change the course of the epidemic."
According to a UCSD statement, early data from the Phase I clinical trial of the Moderna vaccine, which began in mid-March, was sufficiently encouraging that the NIH, the National Institute for Allergy and Infectious
Diseases and Moderna have expedited the research and development process -- something that can take years.
Their Phase I findings were published in the The New England Journal of Medicine.
In it, researchers said that participants who received the two-dose vaccine produced more antibodies to the novel coronavirus than have been seen in most patients who have recovered from COVID-19. By interfering with the way in which pathogens --- such as viruses, bacteria and microbial toxins -- interact with host cells, the antibodies can render pathogens non-infectious.
The Phase I trial cohort was split between three groups receiving 25-microgram, 100-microgram or 250-microgram injections in the arm, spaced 28 days apart, with resulting antibody levels higher with higher dosages. The vaccine was generally well-tolerated.
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No serious side effects were reported, but more than half of participants described temporary fatigue, chills, headache and muscle pain. The largest dose produced more serious reactions and will not be used in the Phase III study, which will test only the 100-microgram dose.
The Phase III trial will recruit up to 30,000 participants at multiple sites across the nation. At UCSD, the trial will be conducted through the Mother, Child and Adolescent Program.
UCSD is one of three participating trial sites in the region, and expects to enroll approximately 500 subjects.
Participants in the study trial must be 18 years or older with no known history of SARS-CoV-2 infection. The trial will give preference to participants who live in locations or under circumstances that put them at appreciable risk -- such as high-contact jobs like first responder or grocery store worker, or populations with higher incidence of the illness such as the Native American and Latino populations.
Simultaneous to vaccine testing, officials plan to begin actually producing the test vaccine in large amounts so that if proven effective, there would be significant numbers of doses available by the end of 2020 or early 2021.
For more information about participating in the trial, click here.
