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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Kara Chew
Study ID
NCT06810934
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • CoTend-BXBB (SARS2-30404) — BIOLOGICAL
    Ad35-vectored SARS-CoV-2 RBD (XBB.1.5) vaccine
  • CoTend-s3BXBB (SARS2-17032) — BIOLOGICAL
    Ad35-vectored s3-SARS-CoV-2 RBD (XBB.1.5) vaccine
  • Placebo — BIOLOGICAL
    Sterile sodium chloride 0.9% for injection, preservative free

Study Details

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.

Key Dates

Start date
Oct 21, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dose Cohort 1, Arm 1A
    Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^6 vp (0.5mL) IM once
  • Experimental: Dose Cohort 1, Arm 1B
    Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^6 vp (0.5mL) IM once
  • Experimental: Dose Cohort 2, Arm 2A
    Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^7 vp (0.5mL) IM once
  • Experimental: Dose Cohort 2, Arm 2B
    Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^7 vp (0.5mL) IM once
  • Experimental: Dose Cohort 3, Arm 3A
    Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^8 vp (0.5mL) IM once
  • Experimental: Dose Cohort 3, Arm 3B
    Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^8 vp (0.5mL) IM once
  • Experimental: Dose Cohort 4, Arm 4A
    Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^9 vp (0.5mL) IM once
  • Experimental: Dose Cohort 4, Arm 4B
    Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^9 vp (0.5mL) IM once
  • Experimental: Dose Cohort 5, Arm 5A
    Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^10 vp (0.5mL) IM once
  • Experimental: Dose Cohort 5, Arm 5B
    Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^10 vp (0.5mL) IM once
  • Experimental: Dose Cohort 6, Arm 6A
    Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^9 vp (0.5mL) IM once
  • Experimental: Dose Cohort 6, Arm 6B
    Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^9 vp (0.5mL) IM once
  • Placebo Comparator: Dose Cohort 6, Arm 6C
    Intervention: Placebo (normal saline) Dose: 0.5mL IM once
  • Experimental: Dose Cohort 7, Arm 7A
    Intervention: CoTend-s3BXBB (SARS2-17032) Dose: 1x10\^10 vp (0.5mL) IM once
  • Experimental: Dose Cohort 7, Arm 7B
    Intervention: CoTend-BXBB (SARS2-30404) Dose: 1x10\^10 vp (0.5mL) IM once
  • Placebo Comparator: Dose Cohort 7, Arm 7C
    Intervention: Placebo (normal saline) Dose: 0.5mL IM once

Primary Outcome Measure

Frequency of solicited local reactogenicity adverse events (AEs) within 7 days after dosing. [ Time Frame: 7 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCLA WestwoodLos AngelesCalifornia90095
Kevin Pizarro
[email protected]
310-843-2015
Kara Chew, MD, MS (PRINCIPAL_INVESTIGATOR)
UCSF Community and Clinical Research CenterSan FranciscoCalifornia94110
Marin Ewing
[email protected]
415-353-9599
Steven Deeks, MD (PRINCIPAL_INVESTIGATOR)

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