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NCT06810934 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses
A Phase 1 study of COVID-19 and SARS CoV 2 Infection, sponsored by Kara Chew.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT06810934: Recruiting Phase 1 study of COVID-19 and SARS CoV 2 Infection, sponsored by Kara Chew.
NCT06810934 is a Phase 1 study of COVID-19 and SARS CoV 2 Infection that is actively recruiting participants, run by Kara Chew. The registered enrollment target is 80 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06810934, a Phase 1 study of COVID-19 and SARS CoV 2 Infection, is actively recruiting participants, sponsored by Kara Chew.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Number of participants with solicited local reactogenicity AEs (injection site pain, erythema, or swelling) within 7 days after dosing. An AE is any untoward medical occurrence in a clinical investigation of a patient administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL CoTend-BXBB (SARS2-30404)
- BIOLOGICAL CoTend-s3BXBB (SARS2-17032)
Study Locations (2)
California
- UCLA Westwood - Los Angeles
- UCSF Community and Clinical Research Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-10-21 |
| Est. Completion | 2029-10 |
| Phase | Phase 1 |
What NCT06810934 shows while recruiting
NCT06810934 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06810934 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06810934 about?
NCT06810934 is a clinical study titled "A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses". 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 ...
What is the current status of trial NCT06810934?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2025-10-21. Estimated completion is 2029-10.
What conditions does trial NCT06810934 study?
This clinical trial studies the following conditions: COVID-19, SARS CoV 2 Infection.
What interventions are being tested in trial NCT06810934?
The interventions under investigation include: Placebo (BIOLOGICAL), CoTend-BXBB (SARS2-30404) (BIOLOGICAL), CoTend-s3BXBB (SARS2-17032) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06810934?
This trial is sponsored by Kara Chew, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06810934 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06810934's enrollment target sits among peer trials
80 216th of 298 higher than 78 of 298 other COVID-19 trials
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