PORTLAND, OR (KPTV) - The Providence Cancer Institute announced Thursday that it has received approval from the U.S. Food and Drug Administration to begin a first-in-human clinical trial of a vaccine for protection against COVID-19.
Researchers applied for FDA approval to conduct trials on the vaccine in March.
Providence says the vaccine incorporates immunotherapy expertise scientists have developed throughout three decades of cancer research at the Earle A. Chiles Research Institute.
"The trial we'll be doing, the innovation we see here is not only giving a shot in the arm - it's a DNA vaccine - but adding a small needle like acupuncture which would deliver immune stimulants which would super charge this vaccine along with an electric field that would further charge the immune response," Dr. Rom Leidner, M.D., Providence Cancer Institute oncologist and researcher, said back in March.
The trial will be open to adults who have not been infected with SARS-CoV-2 and are in generally good health with no underlying diseases of the immune system, according to Providence. Researchers will initially test the vaccine in 36 people - half between 18 and 50 years of age, and half over the age of 50.
Providence says volunteers participating in the trial will receive two vaccinations about 30 days apart. They will be monitored for another 60 days with periodic blood tests to evaluate how the immune system is being activated.
Altogether, Providence says volunteers will be followed for 18 months so that researchers can assess possible side effects.
The trial, which is set to start in the near future, will be conducted at Providence Portland Medical Center.
Providence says more information about the trial, including how volunteers can participate, will be available when the study is open for enrollment.
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