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

NCT06810934 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-31

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

CoTend-BXBB (SARS2-30404)

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

BIOLOGICAL

CoTend-s3BXBB (SARS2-17032)

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

BIOLOGICAL

Placebo

Sterile sodium chloride 0.9% for injection, preservative free

Sponsors & Collaborators

  • University of California, San Francisco

    collaborator OTHER

  • University of California, Davis

    collaborator OTHER

  • Tendel Therapies, Inc.

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Kara Chew

    lead OTHER

Principal Investigators

  • Kara Chew, MD, MS · University of California, Los Angeles

  • Steven Deeks, MD · University of California, San Francisco

  • Dennis Hartigan-O'Connor, MD, PhD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2027-12-31
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810934 on ClinicalTrials.gov