Investigational COVID-19 Booster Vaccines for Ages 40-64

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

Recruiting Phase 1 Phase 2 Interventional Study
COVID-19 SARS-CoV-2 Infection
Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
40 – 64
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Prevention
Participants needed
80 (estimated)
Sponsor
Kara Chew · Other
Who this trial is looking for

This trial is looking for healthy adults aged 40 to 64 to test two new COVID-19 booster vaccines. Participants will receive one dose of either vaccine or a placebo and will be monitored for side effects, with samples taken to measure immune response.

Are You a Good Fit for This Trial?
Rules you out Active malignancyHIV infectionHistory of myocarditisAutoimmune diseaseHistory of thrombosis

You may be able to join if

  • I am between 40 and 64 years old.
  • I have received at least two doses of a COVID-19 mRNA vaccine more than 120 days ago.
  • I do not have a current SARS-CoV-2 infection.
  • I meet specific laboratory health criteria.
  • I am not pregnant or breastfeeding.
  • I am able and willing to provide informed consent.

You may not be able to join if

  • I am pregnant or breastfeeding.
  • I am unwilling to use contraception if I can become pregnant.
  • I have been in close contact with someone who has COVID-19 in the last two weeks.
  • I plan to get another COVID-19 vaccine within 8 weeks after the study starts.
  • I have HIV infection.
  • I have a history of certain serious autoimmune diseases.
  • I have had certain heart conditions.
  • I am currently receiving treatment for cancer.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 investig…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 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 m…
Contacts

Kara Chew, MD, MS

310-825-0796

kchew@mednet.ucla.edu

CONTACT

Stephanie Buchbinder, MPH

310-825-5147

SBuchbinder@mednet.ucla.edu

CONTACT