FDA approves Providence COVID-19 vaccine clinical trial
The U.S. Food and Drug Administration has granted Providence Cancer Institute researchers approval to begin a first-in-human clinical trial of a vaccine to protect against COVID-19. Providence expects to begin vaccinating participants as early as December.
The Providence Cancer Institute COVID vaccine will be one of 18 in clinical trials in the U.S., and 67 throughout the world (according to the Nov. 17 New York Times).
Since March, generous donors have given $3.5 million to support Providence’s COVID-19 response and research in Oregon, including development of this vaccine.
Clinical trial details
The trial will enroll 36 volunteers in the initial phase, and we’re working quickly to open the study. Our focus involves older adults, who are among the most vulnerable to COVID-19 and who may not receive adequate protection from other COVID-19 vaccines currently in development.
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. Researchers initially will test the vaccine in 36 people, half between 18 and 50 years of age, and half over the age of 50.
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, volunteers will be followed for 18 months so we can assess possible side effects.
Providence will announce details about how to volunteer for the vaccine in the near future.
Science behind the vaccine
The vaccine targets the stabilized SARS-CoV-2 “spike” that the virus uses to attach to and infect a person’s healthy cells, causing the COVID-19 disease. Vaccination should induce T cells and antibody-producing B cells that can recognize the “spike.” When antibodies bind to the receptor binding domain of the “spike,” it neutralizes the virus, preventing the virus from being able to infect a cell, and allows other cells of the immune system to recognize and destroy the virus. The higher the titer of neutralizing antibody, the more likely that person is protected from infection.
T cells don’t recognize the virus per se but can recognize and destroy cells that are infected with the virus. T cells from individuals immunized with the “spike” can also make cytokines that help B cells make more and potentially better antibodies against the “spike.” The trial will test whether the vaccine activates the immune system as intended, to generate antibodies and T cells that can attack SARS-CoV-2. An important innovation in this clinical trial is that it will include a combination of “spike” protein DNA vaccine and immune-boosting interleukin 12 (IL-12) plasmid, which may promote a more effective two-pronged immune response. Our cancer labs have shown in preclinical studies that IL-12 can boost the anti-cancer immune response.
The team will closely study development of the immune response to the virus. If the addition of IL-12 is shown to enhance the immune response in older adults, it could benefit the scientific community worldwide.
In developing the SARS-CoV-2 vaccine, Providence researchers first received a piece of COVID-19 sample virus DNA from the National Institutes of Health. Hong-Ming Hu, Ph.D., head of Providence’s Cancer Immunobiology Lab, engineered this small piece of viral “spike” DNA into a bacteria that was tested, to ensure it worked like a miniature manufacturing plant to make copies of the “spike” DNA.
Article authored by:
Rom Leidner, M.D., principal investigator; co-medical director, Providence Head and Neck Cancer Program
Bernard Fox, Ph.D., vaccine team leader; Harder Family Endowed Chair for Cancer Research and head of Providence’s Laboratory of Molecular and Tumor Immunology