Actively Recruiting
A Phase 1/2A, 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
205 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
The goal of this clinical trial is to test two investigational COVID-19 booster vaccines, called CoTend-s3BXBB and CoTend-BXBB, in healthy volunteers ages 40-64. The CoTend-s3BXBB vaccine includes a component called "s3", which was designed to improve the body's response to the vaccine. CoTend-BXBB is the same vaccine without s3. The main questions the study aims to answer are: 1) Is the investigational vaccine safe? 2) Does "s3" lead to bigger, broader, and longer-lasting responses to the vaccine? 5 different doses of the vaccines will be studied. Participants will receive a single dose of either CoTend-s3BXBB, CoTend-BXBB, or placebo. Participants will be monitored for side effects. Saliva, nasal, and blood samples will be collected and immune responses to the vaccine will be measured.
CONDITIONS
Official 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...
- Aged 40 to 64 years
- Received at least two doses of Moderna or Pfizer COVID-19 mRNA vaccine more than 120 days before study entry
- Negative nasal SARS-CoV-2 PCR test at screening
- Meet laboratory criteria at screening: WBC > 3500 cells/mm3, ANC > 1500 cells/mm3, hemoglobin > 13.5 g/dL if male or > 12.0 g/dL if female, platelet count > 140,000/uL, creatinine clearance > 50 mL/min, total bilirubin ≤ 1.1x upper limit of normal, AST ≤ 1.3x upper limit of normal, ALT ≤ 1.3x upper limit of normal
- Negative pregnancy test within 48 hours prior to entry for individuals of reproductive potential
- Able and willing to provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Unwilling to use two forms of contraception including a barrier method if able to become pregnant
- Known close contact with confirmed COVID-19 case within 2 weeks before study entry
- Plan to receive non-study COVID-19 vaccine within 8 weeks after entry
- HIV infection
- Positive hepatitis B core antibody or surface antigen
- Active hepatitis C infection or recent antiviral therapy within 3 months
- History of cirrhotic liver disease
- History of thrombosis with thrombocytopenia syndrome or related thrombotic conditions
- History or active autoimmune disease requiring systemic immunosuppressive therapy
- History of myocarditis, pericarditis, or myopericarditis
- Signs of myocarditis or pericarditis at screening
- History of Guillain-Barré syndrome
- History of coagulopathy or bleeding disorder contraindicating injections
- Symptomatic acute or chronic illness requiring ongoing care in past 3 months
- Serious medical or psychiatric illness interfering with study participation
- Recent use of systemic immunosuppressive drugs within 30 days
- Active or recent malignancy within 4 years (except certain skin or intraepithelial cancers)
- History of organ or stem cell transplant
- Primary immunodeficiency disorder
- Ongoing complications from prior malignancies requiring intervention
- Recent or planned blood product or non-COVID vaccine administration within 14 days
- Receipt of COVID-19 antibody therapy in past 6 months
- Receipt or planned immunoglobulin therapy during study
- Prior receipt of any non-mRNA COVID-19 vaccine
- COVID-19 vaccination or infection within 120 days prior to entry
- History of severe allergic reaction to vaccine components
- Participation in another interventional clinical study within 28 days
- Any other clinical concerns affecting participant safety
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UCLA Westwood
Los Angeles, California, United States, 90095
Actively Recruiting
2
UCSF Community and Clinical Research Center
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
K
Kara Chew, MD, MS
CONTACT
S
Stephanie Buchbinder, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
16
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