FDA Approves Providence Cancer Institute COVID-19 Vaccine Trial

The U.S. Food and Drug Administration gave Providence Cancer Institute researchers approval to begin a first-in-human clinical trial of a vaccine for protection against COVID-19. The Providence vaccine is unique in that it incorporates immunotherapy expertise scientists have developed throughout three decades of cancer research at the Earle A. Chiles Research Institute. The trial will enroll 36 volunteers in the initial phase, and researchers are working to open the study without delay. This COVID vaccine is one of 18 in clinical trials in the U.S., and 45 throughout the world.

Trial designed with older adults in mind

Providence researchers anticipate that older adults – who are among the most vulnerable to COVID-19 illness – may not receive adequate protection from other COVID-19 vaccines in development.

The convention is to test 18 – 50-year-olds in phase I vaccine trials. However, people over the age of 50 are known to have increased risk for life-threatening illness from SARS-CoV-2. A vaccine that is safe and effective for older adults is essential.

“We designed our trial with older adults in mind. By drawing on our experience in immunotherapy, our aim is to develop a vaccine that boosts the immune response to COVID-19 in older people,” said Rom Leidner, M.D., co-medical director, Providence Head and Neck Cancer Program, and the trial’s principal investigator.

The trial will be open to adults who have not been infected with SARS-CoV-2 and are in general good health with no underlying diseases of the immune system. Researchers will initially 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 that researchers can assess possible side effects.

Researchers turn their cancer expertise to the COVID-19 fight

Scientists at the Earle A. Chiles Research Institute at Providence’s Robert W. Franz Cancer Center have spent three decades singularly focused on immunotherapy and cancer vaccines; in mid-March they turned their expertise and knowledge to the COVID-19 fight, and began developing a vaccine against SARS-CoV-2.

Their vaccine is designed to mobilize the immune system on two fronts simultaneously – antibodies and T cells – both targeting the “spike” which the virus uses to attach to and infect a person’s healthy cells, causing the COVID-19 disease. When the antibodies bind to the “spike” protein of the virus, and the T cells recognize the “spike,” the immune system launches a two-pronged attack to destroy the virus. Since March, donors have given $3.3 million in support of Providence's COVID-19 response and research in Oregon.

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.

The 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. Providence scientists have shown that IL-12 can boost the immune response in preclinical cancer studies.

The vaccine team is led by Bernard Fox, Ph.D., Harder Family Endowed Chair for Cancer Research and head of Providence’s Laboratory of Molecular and Tumor Immunology, and Dr. Leidner.

“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,” says Fox.

The team will closely study the 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.

Providence researchers are developing the COVID-19 vaccine in collaboration with biotech companies OncoSec and UbiVac. Under Fox’s guidance, UbiVac scientists produced a master cell bank of the bacteria necessary for vaccine manufacture, grew large quantities of the bacteria, isolated the plasmid DNA, and tested it for sterility, identity and function.

Due to the urgency of the pandemic, the team began manufacturing at the same time they applied for FDA approval.

The trial and continued monitoring will be conducted at Providence Portland Medical Center in Portland, Oregon. For more information, including how volunteers can participate, contact the Providence research team.

To support the Providence COVID-19 response and research in Oregon, make a donation

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About Providence Cancer Institute

Providence Cancer Institute, a part of Providence St. Joseph Health, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally-renowned research. Providence Cancer Institute is home to the Earle A. Chiles Research Institute, a world-class research facility located within the Robert W. Franz Cancer Center in Portland, Oregon, and is a recognized leader in the field of cancer immunotherapy since 1993. Visit providenceoregon.org/cancer to learn more.

 

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