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TERMINATEDPHASE3

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

A Phase III, Prospective, Open-Label, Randomized Clinical Trial Evaluating the Augmenting of Anti-SARS-CoV2 Immunity in Kidney Transplant Recipients Via a Heterologous Additional Dose With Janssen Ad26.CoV2.S Vaccine

NCT05220397•Mark Stegall

View on ClinicalTrials.gov

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).

Detailed Description

Early after receiving an messenger ribonucleic acid (mRNA) COVID-19 vaccination, most of the general population achieves an anti-COVID spike protein antibody \>250 U/ml. A large percentage of transplant patients form no anti-COVID spike protein antibody or have levels \<250U/ml even early after vaccination. While a direct correlation between any specific anti-COVID spike protein antibody has not been studied extensively, transplant patients do appear to have higher rates of COVID infections and possibly higher mortality rates. Thus, 250 U/ml (the saturation level of the assay below which does not require dilutions) is the target level of anti-COVID spike protein antibody, as that will be considered a "normal" response to the vaccine in this clinical trial. There is no data for intermediate levels of antibody (likely the higher the better the protection). In the absence of any intermediate level data, this study aims to achieve a normal response in transplant recipients receiving the Janssen Ad26.COV2.S vaccine. This study is a phase III, prospective, open label clinical trial with one randomized arm. Its goal is to meet the unmet clinical need to provide vaccine induced immunity for immunocompromised kidney transplant patients after receiving two or three doses of the Pfizer or Moderna COVID-19 vaccine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Criteria for Entry into the Study:
•Any kidney transplant recipient from Mayo Clinic who has received the mRNA vaccine (two or three dose mRNA vaccine-Moderna or Pfizer) and are \>28 days after most recent vaccination at the time of spike protein assessment.
•Recipients of a kidney transplant, including those transplanted with other solid organ transplants in addition to the kidney. Subjects may have received more than 1 kidney transplant.
•More than 90 days since any transplant including a kidney transplantation. •≥18 years of age on the day of consent.
•Criteria for Entry into Segment I
•Must have a Roche Elecsys® Anti-SARS-CoV-2 S level of \<250 U/mL to be eligible for Segment I.
•Platelet count of \>75,000/µL on the day of vaccination with the Janssen Ad26.CoV2.S vaccine.
•Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
•Before randomization, participants must be either:
•* Not be of childbearing potential
+12 more criteria

Exclusion Criteria

•Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºCelsius (C) (100.4°Fahrenheit \[F\]) within 24 hours prior to the planned 1st dose of the Janssen Ad26.CoV2.S vaccine; randomization at a later date is permitted at the discretion of the sponsor-investigator.
•Has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the Janssen Ad26.CoV2.S vaccine; refer to the Investigative Brochure).
•Subject has received or plans to receive:
•* Licensed live attenuated vaccines -within 28 days before or after planned administration of the 1st or subsequent Janssen vaccinations.
•* Other licensed (not live) vaccines -within 14 days before or after planned administration of the 1st or subsequent Janssen vaccinations.
•Received an investigational drug within 30 days (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days of the Janssen Ad26.CoV2.S vaccine. Received investigational Ig or investigational monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral- vectored vaccines) within 6 months before the planned administration of the 1st dose of the Janssen Ad26.CoV2.S vaccine or is currently enrolled or plans to participate in another investigational study within 3 months after the last Jansen vaccination.
•Note: Participation in an observational clinical study is allowed at the sponsor-investigator's discretion; please notify the sponsor-investigator of this decision. Efforts will be made to ensure inclusion of participants who have not been previously enrolled in coronavirus studies. In order to participate subject must agree and understand that they cannot enroll in other coronavirus focused studies while participating in this one.
•Is pregnant or planning to become pregnant at the time of consent and within 3 months of the last dose of the Janssen Ad26.CoV2.S vaccine.
•Has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings which, in the opinion of the sponsor-investigator, would make study participation not be in the participant's best interest (e.g., compromise the well- being) or that could prevent, limit, or confound the protocol-specified assessments.
•Has a contraindication to Intramuscular (IM) injections and blood draws.
+10 more criteria

Locations (3)

Mayo Clinic

Phoenix, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

April 11, 2022

Primary Completion Date

February 28, 2025

Completion Date

February 28, 2025

Last Updated

September 15, 2025

Enrollment

468

ACTUAL participants

Conditions

Kidney Transplant Recipient

Interventions

Janssen Ad26.CoV2.S Vaccine

BIOLOGICAL

Reduction in Immunosuppression Medication

OTHER

Maintenance in Immunosuppression Medication

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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