A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
Eligible age
40–64 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Kara Chew
You may qualify if…
- ✓ 1. Individuals 40 - 64 years of age
- ✓ 2. Received at least two doses of a COVID-19 mRNA vaccine (Moderna or Pfizer) \> 120 days before study entry
- ✓ 3. Nasal SARS-CoV-2 negative by molecular (polymerase chain reaction, PCR) testing at screening
- ✓ 4. The following laboratory criteria must be met at screening:
- ✓ 1. Total white blood cell (WBC) count \> 3500 cells/mm3
- ✓ 2. Absolute neutrophil count (ANC) \> 1500 cells/mm3
- ✓ 3. Hemoglobin \> 13.5 g/dL if male sex and \> 12.0 g/dL if female sex
- ✓ 4. Platelet count \> 140,000/uL
You may not qualify if…
- ✕ Participants are excluded from the study if any of the following criteria are met:
- ✕ 1. Pregnant or breastfeeding
- ✕ 2. For participants capable of becoming pregnant and engaging in sexual activity that can lead to pregnancy, unwillingness to use contraception during participation in the study. For participants capable of becoming pregnant, two of the following forms of contraception are required through 30 days following administration of study intervention, one of which must be a barrier method:
- ✕ 1. Condoms (male or female) with or without a spermicidal agent
- ✕ 2. Diaphragm or cervical cap with spermicide
- ✕ 3. Intrauterine device (IUD)
- ✕ 4. Hormone-based contraceptive such as oral birth control pills
- ✕ 3. Known close contact with anyone with confirmed SARS-CoV-2 infection (defined as positive SARS-CoV-2 nucleic acid or antigen testing by laboratory-based or home self-test) within 2 weeks prior to expected study entry
Where it's recruiting
Los Angeles · San Francisco
Source: ClinicalTrials.gov · NCT06810934 · last updated 2025-10-31