UC Davis Health will be testing a new vaccine for children ages 12-17 to support the fight against COVID-19. It will soon open as an extension of the current, stage 3 clinical trial with the National Institutes of Health (NIH) and Novavax locally led by Stuart Cohen, chief of the Division of Infectious Diseases and director of Hospital Epidemiology and Infection Prevention at UC Davis Health. The pediatric portion will be led by Dean Blumberg, chief of pediatric infectious diseases at UC Davis Children’s Hospital.
The two-year pediatric portion of the study aims to enroll up to 3,000 adolescents in the U.S, with 100 participants at UC Davis Health.
How does the vaccine work?
The Novavax vaccine, called NVX-CoV2373, contains a subunit from the spike protein in SARS-CoV-2, the virus causing COVID-19. The spike protein is the main target for development of immunity. The subunit is combined with an adjuvant, a boosting agent to improve the body’s immune response to the vaccine. When this combination enters the body, it triggers an immune response to the spike protein and creates antibodies to fight it.
“The vaccine contains protein antigens that cannot replicate or cause COVID-19. The antibodies generated to the vaccine will help protect the body from the real, fully-potent virus,” Cohen said.
UC Davis Health is part of Novavax’s Adult Phase III trial which includes approximately 30,000 participants. The vaccine, a two-dose regimen, is not yet approved for Emergency Use in the U.S. It is currently under review by the Food and Drug Administration (FDA).
Who can participate?
- Must be 12 to 17 years old
- Are physically healthy
- Have not been diagnosed with COVID-19 in the past
- Are not participating in any other COVID-19 research trials
- Not prescribed immunosuppressant or corticosteroid medication
- Can be HIV-positive if the HIV is well-controlled
This study will require in-person visits to UC Davis Medical Center. At these visits, the study team will thoroughly explain all procedures and answer any questions. If both the child and their guardian consent to participation, the team will assess the child's health. They will also gather a blood sample, inject the vaccine or a placebo, and observe the child for 30 minutes. The child will come back after three weeks to get the second shot.
As it is a blind, randomized trial, neither the participants nor the researchers will know who gets the vaccine and who receives the placebo.
“Thousands of children have been hospitalized and hundreds have died due to COVID-19. We need to vaccinate children both to protect them and to decrease transmission in our communities,” Blumberg said. “This is why it is important to make sure that there are safe and effective vaccines for all ages.”
Participants will receive compensation. For more information or to sign up, visit the study’s webpage.