Actively Recruiting
A Phase 12A, Randomized Study of a T Follicular Helper TFH-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
Led by Kara Chew · Updated on 2025-10-31
80
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
K
Kara Chew
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two investigational COVID-19 booster vaccines called CoTend-s3BXBB and CoTend-BXBB in healthy adults aged 40 to 64. The CoTend-s3BXBB vaccine includes a component named s3 designed to enhance the bodys immune response, while CoTend-BXBB is the same vaccine without this component. The study aims to determine if the vaccines are safe and whether the s3 component generates a stronger, broader, and longer-lasting immune response. Participants will receive a single injection of one of the vaccines at varying doses, or a placebo. The vaccines are delivered as intramuscular shots, with doses ranging from 1x106 to 1x1010 viral particles in a 0.5 mL volume. There are multiple study groups receiving different doses of either CoTend-s3BXBB, CoTend-BXBB, or placebo. Participants will be randomly assigned to these groups in a blinded manner. During the study, participants will be closely monitored for any side effects for up to 28 days after dosing and for serious events through longer follow-up visits up to 104 weeks. Samples of saliva, nasal secretions, and blood will be collected to measure immune responses, including antibody levels and T cell responses, through various timepoints up to two years. Safety assessments include tracking local and systemic reactions, adverse events, and medically attended issues.
CONDITIONS
Brief Title
A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 40 to 64 years
- Received at least two doses of an mRNA COVID-19 vaccine (Moderna or Pfizer) more than 120 days before study entry
- Negative nasal PCR test for SARS-CoV-2 at screening
- Meet specific laboratory criteria including white blood cell count, neutrophil count, hemoglobin, platelet count, creatinine clearance, bilirubin, AST, and ALT levels
- Negative pregnancy test for individuals of reproductive potential within 48 hours before entry
- Able and willing to provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Unwilling to use contraception if capable of becoming pregnant and sexually active
- Known close contact with confirmed COVID-19 case within 2 weeks prior to study entry
- Plan to receive a non-study COVID-19 vaccine within 8 weeks after study entry
- HIV infection
- Positive for hepatitis B core antibody or surface antigen at screening
- Active hepatitis C or recent antiviral therapy for hepatitis C
- History of liver cirrhosis
- History of thrombosis with thrombocytopenia syndrome or related clotting disorders
- History or active autoimmune disease requiring immunosuppressive therapy
- History of myocarditis, pericarditis, or myopericarditis
- Potential myocarditis or pericarditis at screening
- History of Guillain-Barré syndrome
- History of bleeding disorders contraindicating injections or blood draws
- Recent symptomatic illness requiring medical care
- Serious medical or psychiatric illness interfering with study participation
- Recent use of systemic immunosuppressive drugs
- Active or recent malignancy within 4 years (except certain skin or cervical lesions)
- History of organ or stem cell transplantation
- Primary immunodeficiency disorder
- Ongoing complications from prior malignancies requiring treatment
- Recent administration or planned administration of blood products or non-study vaccines
- Recent receipt of antibody-based COVID-19 therapies
- Recent or planned immunoglobulin therapy
- Prior receipt of any non-mRNA COVID-19 vaccine
- Recent receipt of any COVID-19 vaccination within 120 days
- Documented COVID-19 infection within 120 days
- History of severe allergic reactions to vaccines containing similar components
- Participation in another interventional study within 28 days or planned during this study
- Any safety concerns as judged by the investigator
Research Team
K
Kara Chew, MD, MS
S
Stephanie Buchbinder, MPH
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