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

NCT05220397 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 21-008036
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

kidney transplant; renal transplant; COVID-19; COVID-19 vaccine; Janssen Ad26.CoV2.S vaccine; adenovector vaccine

Outcome Measures

Primary Outcomes (2)

• Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Low Level Anti-COVID Spike Protein at Enrollment

  Number of patients with initial anti-COVID spike protein antibody levels \>0 but \<250U/ml at enrollment who receive the Janssen Ad26.CoV2.S vaccine who develop anti-COVID spike protein antibody levels greater than or equal to 250 U/mL at 28 days.

  28 days following first dose of Janssen Ad26.CoV2.S vaccine

• Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Undetectable Anti-COVID Spike Protein at Enrollment

  Number of patients with undetectable anti-COVID spike protein antibody level at enrollment who receive the Janssen Ad26.CoV2.S vaccine who develop anti-COVID spike protein antibody levels greater than or equal to 250 U/mL at 28 days.

  28 days following first dose of Janssen Ad26.CoV2.S vaccine

Secondary Outcomes (3)

• Response to the Janssen Ad26.CoV2.S Vaccine in Subjects Who Had Low or Undetectable Levels of Anti-COVID Spike Protein After the First Dose of the Janssen Vaccine

  28 days after second dose of Janssen Ad26.CoV2.S vaccine, up to 2 months

• Durability of Anti-COVID Spike Protein Antibody Levels in Patients Who Developed Any Level of Antibody Response After Receiving the Janssen Ad26.CoV2.S Vaccine.

  2 years

• Incidence of COVID-19 Infection

  2 years

Study Arms (5)

Initial Responders

NO INTERVENTION

Individuals who have previously received the Pfizer or Moderna vaccines and have high levels of spike antibodies in their blood, will receive standard of care immunosuppressive (IS) medications.

Low Level (LL) Spike Antibodies: Janssen Vaccine Responders

EXPERIMENTAL

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were greater than or equal to 250 U/mL. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle

Biological: Janssen Ad26.CoV2.S Vaccine

Low Level (LL) Spike Antibodies: Janssen Vaccine Non-Responders

EXPERIMENTAL

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects received one dose of the Janssen Ad26.CoV2.S vaccine. After receiving the Janssen Ad26.CoV2.S vaccine, their spike protein test results were less than 250 U/mL. 28 days following the first dose of the Janssen Ad26.CoV2.S vaccine, subjects were given a second dose of Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle

Biological: Janssen Ad26.CoV2.S Vaccine

Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication

EXPERIMENTAL

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to maintain their current immunosuppression medication regimen and then receive a Janssen Ad26.CoV2.S vaccine. 28 days after receiving the first dose of the Janssen Ad26.CoV2.S vaccine, if a subject's spike protein test results were less than 250 U/mL then a second dose of the Janssen Ad26.CoV2.S vaccine was administered. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Maintenance in Immunosuppression Medication: Maintain current immunosuppression medication dosage

Biological: Janssen Ad26.CoV2.S Vaccine; Other: Maintenance in Immunosuppression Medication

Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication

EXPERIMENTAL

Individuals who had a spike protein test result less than 250 U/mL at the screening visit. Subjects were randomized to change their current immunosuppression medication regimen and then receive an additional Janssen Ad26.CoV2.S vaccine. Janssen Ad26.CoV2.S Vaccine: Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle Reduction in Immunosuppression Medication: Reduction in immunosuppression medication dosage

Biological: Janssen Ad26.CoV2.S Vaccine; Other: Reduction in Immunosuppression Medication

Interventions

Janssen Ad26.CoV2.S Vaccine BIOLOGICAL

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

Low Level (LL) Spike Antibodies: Janssen Vaccine Non-Responders; Low Level (LL) Spike Antibodies: Janssen Vaccine Responders; Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication; Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication

Reduction in Immunosuppression Medication OTHER

Reduction in immunosuppression medication dosage

Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication

Maintenance in Immunosuppression Medication OTHER

Maintain current immunosuppression medication dosage

Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Of childbearing potential and practicing an acceptable effective method of contraception. Subject must agree to remain on contraception from date of consent until 3 months after the last dose of the Janssen Ad26.CoV2.S vaccine. Use of hormonal contraception should start at least 28 days before the 1st administration of the Janssen Ad26.CoV2.S vaccine. The sponsor-investigator should evaluate the potential for contraceptive method failure (for example, noncompliance, recently initiated) in relationship to the Janssen vaccination. Acceptable effective method for this study include:
• Hormonal contraception:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
• Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
• Intrauterine device

You may not qualify if:

• 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.
• 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.
• Has had major psychiatric illness, which in the sponsor-investigator's opinion would compromise the participant's safety or compliance with the study procedures.
• Cannot communicate reliably with the sponsor-investigator or comply with study procedures.
• In the opinion of the sponsor-investigator, is unlikely to adhere to the requirements of the study or is unlikely to complete the full course of protocol required vaccination and observation.
• History of cancer malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or other malignancies with minimal risk of recurrence).
• History of acute polyneuropathy (e.g., Guillain-Barré syndrome)
• Chronic history of platelet count \<75,000/µL.

Sponsors & Collaborators

• Mark Stegall: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Park WD, Nair SS, Wadei HM, Liang Y, Smith BH, Abdelrheem A, Schinstock CA, Isham CR, Kumanovics A, Ahmad N, Simonson RB, Ryser MF, Tapia-Cealle G, Badley AD, Stegall MD. Responses of Kidney Transplant Recipients to Vaccination and Boosting. Mayo Clin Proc. 2025 Sep;100(9):1506-1518. doi: 10.1016/j.mayocp.2025.03.017. Epub 2025 Jul 16.

  PMID: 40663029 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Limitations and Caveats

This study was terminated early due to Janssen Biotech, Inc withdrawing the emergency use authorization from the FDA on May 22, 2023, as there was no demand for the new lots of Janssen COVID-19 vaccine in the United States. The vaccine was no longer being produced nor available by Janssen as of 2023.

Results Point of Contact

• Title: Mark Stegall, M.D.
• Organization: Mayo Clinic

stegall.mark@mayo.edu

507-266-2812

Study Officials

• Mark D Stegall, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 2, 2022
• Study Start: April 11, 2022
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)