COVID-19 Booster Vaccines for Coronavirus
(CONTENDER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new COVID-19 booster vaccines, CoTend-s3BXBB and CoTend-BXBB, to evaluate their safety and immune-boosting effectiveness. CoTend-s3BXBB includes an extra component to enhance the body's response, and the study will compare it to CoTend-BXBB, which lacks this component. Researchers seek healthy volunteers who have received two doses of a COVID-19 vaccine and are free from COVID-19 infection. Participants will help determine if the new component results in stronger and longer-lasting immunity. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, if you are on systemic immunosuppressive or immunomodulatory drugs, you may not be eligible. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that COVID-19 vaccines, such as CoTend-s3BXBB and CoTend-BXBB, are generally well-tolerated. In similar vaccine trials, most side effects were mild to moderate and resolved within a few days, often including sore arms or slight fatigue.
As this trial is in its early stages, the primary focus is on assessing the safety of these vaccines and the body's response to them. While much remains to be learned, early studies suggest the vaccines are unlikely to cause serious issues. Participants will receive close monitoring for any potential side effects during the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about CoTend-BXBB and CoTend-s3BXBB because these booster vaccines offer new approaches to enhancing immunity against COVID-19. Unlike existing mRNA vaccines, which have been the primary option, CoTend-BXBB and CoTend-s3BXBB use a viral vector platform. This platform potentially allows for a broader immune response and could offer longer-lasting protection. Moreover, these boosters are being explored at various dosage levels to optimize their effectiveness and safety. This innovative approach might improve how we tackle emerging variants of the virus.
What evidence suggests that this trial's treatments could be effective for COVID-19?
This trial will evaluate two COVID-19 booster vaccines, CoTend-s3BXBB and CoTend-BXBB, across various treatment arms. Studies have shown that COVID-19 booster vaccines can significantly reduce the risk of severe illness, with some boosters proving over 92.5% effective in the first three months after administration. The CoTend-s3BXBB vaccine includes an additional component called "s3," designed to enhance the body's immune response, potentially offering stronger and longer-lasting protection compared to vaccines without this component. While specific data for CoTend-s3BXBB and CoTend-BXBB is still being collected in this trial, the "s3" component aims to help the vaccine combat the virus more effectively. Early indications suggest this approach could enhance immunity against COVID-19.12345
Who Is on the Research Team?
Kara Chew, MD, MS
Principal Investigator
University of California, Los Angeles
Steven Deeks, MD
Principal Investigator
University of California, San Francisco
Dennis Hartigan-O'Connor, MD, PhD
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
Healthy individuals aged 40-64 who have had at least two doses of a COVID-19 mRNA vaccine over 120 days ago. They must test negative for SARS-CoV-2, have normal blood cell counts and organ function tests. People with certain medical conditions or abnormal lab results are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of either CoTend-s3BXBB, CoTend-BXBB, or placebo and are monitored for side effects. Saliva, nasal, and blood samples are collected to measure immune responses.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the collection of adverse event data and immune response measurements.
Long-term follow-up
Participants are monitored for long-term safety and immune response durability, including the collection of adverse event data and immune response measurements.
What Are the Treatments Tested in This Trial?
Interventions
- CoTend-BXBB
- CoTend-s3BXBB
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kara Chew
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
University of California, San Francisco
Collaborator
University of California, Davis
Collaborator
Tendel Therapies, Inc.
Collaborator