Actively Recruiting

Phase 1
Phase 2
Age: 40Years - 64Years
All Genders
Healthy Volunteers
ID06810934

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

Led by Kara Chew · Updated on 2025-10-31

80

Participants Needed

2

Research Sites

95 weeks

Total Duration

On this page

Sponsors

K

Kara Chew

Lead Sponsor

U

University of California, San Francisco

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two investigational COVID-19 booster vaccines called CoTend-s3BXBB and CoTend-BXBB in healthy adults aged 40 to 64. The CoTend-s3BXBB vaccine includes a component named "s3" designed to enhance the body's immune response, while CoTend-BXBB is the same vaccine without this component. The study aims to determine if the vaccines are safe and whether the "s3" component generates a stronger, broader, and longer-lasting immune response. Participants will receive a single injection of one of the vaccines at varying doses, or a placebo. The vaccines are delivered as intramuscular shots, with doses ranging from 1x10^6 to 1x10^10 viral particles in a 0.5 mL volume. There are multiple study groups receiving different doses of either CoTend-s3BXBB, CoTend-BXBB, or placebo. Participants will be randomly assigned to these groups in a blinded manner. During the study, participants will be closely monitored for any side effects for up to 28 days after dosing and for serious events through longer follow-up visits up to 104 weeks. Samples of saliva, nasal secretions, and blood will be collected to measure immune responses, including antibody levels and T cell responses, through various timepoints up to two years. Safety assessments include tracking local and systemic reactions, adverse events, and medically attended issues.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 40 to 64 years
  • Received at least two doses of an mRNA COVID-19 vaccine (Moderna or Pfizer) more than 120 days before study entry
  • Negative nasal PCR test for SARS-CoV-2 at screening
  • Meet specific laboratory criteria including white blood cell count, neutrophil count, hemoglobin, platelet count, creatinine clearance, bilirubin, AST, and ALT levels
  • Negative pregnancy test for individuals of reproductive potential within 48 hours before entry
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Unwilling to use contraception if capable of becoming pregnant and sexually active
  • Known close contact with confirmed COVID-19 case within 2 weeks prior to study entry
  • Plan to receive a non-study COVID-19 vaccine within 8 weeks after study entry
  • HIV infection
  • Positive for hepatitis B core antibody or surface antigen at screening
  • Active hepatitis C or recent antiviral therapy for hepatitis C
  • History of liver cirrhosis
  • History of thrombosis with thrombocytopenia syndrome or related clotting disorders
  • History or active autoimmune disease requiring immunosuppressive therapy
  • History of myocarditis, pericarditis, or myopericarditis
  • Potential myocarditis or pericarditis at screening
  • History of Guillain-Barré syndrome
  • History of bleeding disorders contraindicating injections or blood draws
  • Recent symptomatic illness requiring medical care
  • Serious medical or psychiatric illness interfering with study participation
  • Recent use of systemic immunosuppressive drugs
  • Active or recent malignancy within 4 years (except certain skin or cervical lesions)
  • History of organ or stem cell transplantation
  • Primary immunodeficiency disorder
  • Ongoing complications from prior malignancies requiring treatment
  • Recent administration or planned administration of blood products or non-study vaccines
  • Recent receipt of antibody-based COVID-19 therapies
  • Recent or planned immunoglobulin therapy
  • Prior receipt of any non-mRNA COVID-19 vaccine
  • Recent receipt of any COVID-19 vaccination within 120 days
  • Documented COVID-19 infection within 120 days
  • History of severe allergic reactions to vaccines containing similar components
  • Participation in another interventional study within 28 days or planned during this study
  • Any safety concerns as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive a single intramuscular injection of the assigned vaccine or placebo.

1 dosing visit (in-person)

Follow-up

Duration - Up to 104 weeks

Participants are monitored for safety and immune response through multiple follow-up assessments.

Multiple visits over 104 weeks, including visits at weeks 1, 8, 26, 52, and 104

Trial Site Locations

Total: 2 locations

1

UCLA Westwood

Los Angeles, California, United States, 90095

Actively Recruiting

2

UCSF Community and Clinical Research Center

San Francisco, California, United States, 94110

Actively Recruiting

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Research Team

K

Kara Chew, MD, MS

S

Stephanie Buchbinder, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

16

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Published Research Related To This Trial

SARS-CoV-2 spike conformation determines plasma neutralizing activity elicited by a wide panel of human vaccines.

John E Bowen, Young-Jun Park, Cameron Stewart...

https://pubmed.ncbi.nlm.nih.gov/36356052

Maintenance of broad neutralizing antibodies and memory B cells 1 year post-infection is predicted by SARS-CoV-2-specific CD4+ T cell responses.

Harikrishnan Balachandran, Chansavath Phetsouphanh, David Agapiou...

https://pubmed.ncbi.nlm.nih.gov/35090598

Safety and Immunogenicity of a Recombinant Adenovirus Serotype 35-Vectored HIV-1 Vaccine in Adenovirus Serotype 5 Seronegative and Seropositive Individuals.

Jonathan D Fuchs, Pierre-Alexandre Bart, Nicole Frahm...

https://pubmed.ncbi.nlm.nih.gov/26587311

Prevalence of neutralizing antibodies to adenoviral serotypes 5 and 35 in the adult populations of The Gambia, South Africa, and the United States.

Edward Nwanegbo, Eftyhia Vardas, Wentao Gao...

https://pubmed.ncbi.nlm.nih.gov/15013987

Durability of Immune Response After COVID-19 Booster Vaccination and Association With COVID-19 Omicron Infection.

Mayan Gilboa, Gili Regev-Yochay, Michal Mandelboim...

https://pubmed.ncbi.nlm.nih.gov/36107426