RecruitingPhase 1Phase 2NCT06810934

A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses


Sponsor

Kara Chew

Enrollment

80 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CoTend-BXBB (SARS2-30404), a biological treatment called CoTend-s3BXBB (SARS2-17032), and others for people with covid-19 and sars-cov-2 infection. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCoTend-BXBB (SARS2-30404)

Ad35-vectored SARS-CoV-2 RBD (XBB.1.5) vaccine

BIOLOGICALCoTend-s3BXBB (SARS2-17032)

Ad35-vectored s3-SARS-CoV-2 RBD (XBB.1.5) vaccine

BIOLOGICALPlacebo

Sterile sodium chloride 0.9% for injection, preservative free


Locations(2)

UCLA Westwood

Los Angeles, California, United States

UCSF Community and Clinical Research Center

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT06810934


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