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Janssen Ad26.CoV2.S Vaccine Booster in Kidney Transplant Recipients

NCT05220397 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2025-09-15

Study results available
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Summary

The purpose of this research is to see if a dose of the Janssen Ad26.CoV2.S vaccine effects the immune protection in individuals who have had a kidney transplant and two or three doses of mRNA vaccine (Pfizer and/or Moderna vaccines).

Conditions

  • Kidney Transplant Recipient

Interventions

BIOLOGICAL

Janssen Ad26.CoV2.S Vaccine

Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle

OTHER

Reduction in Immunosuppression Medication

Reduction in immunosuppression medication dosage

OTHER

Maintenance in Immunosuppression Medication

Maintain current immunosuppression medication dosage

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Mark Stegall

    lead OTHER

Principal Investigators

  • Mark D Stegall, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2025-02-28
Completion
2025-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05220397 on ClinicalTrials.gov