Providence Cancer Institute in Portland is joining the race for a COVID-19 vaccine with the launch of an early phase clinical trial involving a three dozen volunteers.
The institute announced Thursday it had received approval from the U.S. Food and Drug Administration, which regulates the pharmaceutical industry, to start the Phase 1 trial. The first phase of clinical tests are designed to test the safety of a drug on a limited number of healthy people to ensure it’s safe.
Providence said it would start testing at its medical center in Northeast Portland on 36 healthy volunteers who have no underlying conditions. Half will be between the ages of 18 and 50 and half will be older than 50.
Providence’s vaccine candidate joins a field of 60 other COVID-19 vaccines that are in clinical testing, according to the New York Times vaccine tracker. A total of 11 drugs are in Phase 3 testing, the last stage before approval, 14 are in Phase 2, and 35 are in the initial phase.
Providence’s drug is aimed at older patients. They’ve been the most susceptible to severe complications and death. The Oregon Health Authority’s latest data show that Oregonians age 80 and over account for more than 50% of COVID-19 deaths and people 70 and over account for 75% of deaths.
“Our aim is to develop a vaccine that boosts the immune response to COVID-19 in older people,” Dr. Rom Leidner, co-medical director, Providence Head and Neck Cancer Program, and the trial’s principal investigator, said in the release.
Providence scientists have been working on this vaccine since March with the support of $3.3 million from donors, the release said. The researchers are working with two biotech firms, Portland-based UbiVac and OncoSec, which has labs in San Diego, California.
It said the vaccine is designed to mobilize the body’s immune system by stimulating the production of antibodies and T cells, which patrol the body for pathogens. The functionality of T cells decreases with age, which is one reason why older adults have weakened immune systems.
Providence said the vaccine includes genetic material from the so-called spike protein on the novel coronavirus - SARS-CoV-2 - which is what the virus uses to invade cells. Most of the other vaccines being developed are also based on the spike protein, with some directing the cells to produce the protein inside the cells to provoke an immune response.
Providence said they took DNA from the spike protein and produced the vaccine using bacteria and DNA technology. After injection, the vaccine is taken up by cells which express the spike protein and an immune-boosting substance called interleukin 12 or IL-12. That substance, which Providence has used in its immunological studies, stimulates the immune system to response to the spike protein.
“Since older adults frequently have reduced immune responses to vaccines, we are hopeful that IL-12 may enhance the immune response to a vaccine for COVID-19,” said Dr. Bernard Fox, head of Providence's Laboratory of Molecular and Tumor Immunology and a lead researcher.
Providence said the manufacturing process began at UbiVac, a spinoff from Providence cancer research, at the same time that the company applied for FDA approval.
Volunteers will receive two doses of the vaccine a month apart. They will be monitored for 60 days after that with blood tests to check the immune response. Providence said the volunteers will be followed for 18 months in all, to check for side effects.
If the Phase 1 trial goes well, Providence can move to the next phases which look at dosing, effectiveness and safety.
You can reach Lynne Terry at [email protected] or on Twitter @LynnePDX.
