Kidney Transplant RecipientPhase 3NCT05220397
Janssen Ad26.CoV2.S Vaccine Booster in Kidney Transplant Recipients
A Phase 3 study testing Janssen Ad26.CoV2.S Vaccine, Reduction in Immunosuppression Medication and Maintenance in Immunosuppression Medication in people with Kidney Transplant Recipient, run by Mark Stegall at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipient
- What is being tested?
- Janssen Ad26.CoV2.S Vaccine, Reduction in Immunosuppression Medication and Maintenance in Immunosuppression Medication
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Apr 2022to 28 Feb 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion/ligation procedure
- Vasectomized partner (the vasectomized partner should be the sole partner for that participant)
- Sexual abstinence (defined as refraining from heterosexual intercourse from the date of consent until 3 months after the last dose of the Janssen Ad26.CoV2.S vaccine. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.). Note: Use of condoms is not considered as an acceptable contraceptive barrier method due to the failure rate of female and male condoms (Centers for Disease Control and Prevention. Reproductive Health: Contraception. https://www.cdc.gov/reproductivehealth/contraception/index.htm. Accessed 23 November 2020)
- If subject is female and of childbearing potential, she must:
- Have a negative highly sensitive serum pregnancy test prior to vaccination.
- Participant agrees to not donate bone marrow, blood, and blood products from the first Janssen Ad26.CoV2.S vaccine administration until 3 months after the last dose of the Janssen Ad26.CoV2.S vaccine.
Who cannot join
- 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.
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- 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.
- 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.
- History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia (HIS).
- History of capillary leak syndrome (CLS).
- Received pre-exposure prophylactic medications for COVID-19 that could interfere with assessments of any study-related endpoint
- History of myocarditis or pericarditis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Kidney Transplant Recipient
- Being tested
- Janssen Ad26.CoV2.S Vaccine, Reduction in Immunosuppression Medication, Maintenance in Immunosuppression Medication
- Keywords
- kidney transplant, renal transplant, COVID-19, COVID-19 vaccine, Janssen Ad26.CoV2.S vaccine, adenovector vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Janssen Ad26.CoV2.S VaccineBiological
Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle
Reduction in Immunosuppression MedicationOther
Reduction in immunosuppression medication dosage
Maintenance in Immunosuppression MedicationOther
Maintain current immunosuppression medication dosage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Janssen Ad26.CoV2.S Vaccine; Other: Reduction in Immunosuppression Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Number of subjects to achieve an anti-COVID spike protein antibody level greater than or equal to 250 U/mL 28 days after a second dose with the Janssen Ad26.CoV2.S vaccine.
Measured: 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.
As measured by antibody levels from anti-COVID spike protein antibody tests.
Measured: 2 years
Incidence of COVID-19 Infection
Number of subject infected with COVID-19 after enrollment. Criteria for suspected COVID includes: positive reverse transcription-polymerase chain reaction (RT-PCR) result for SARS-CoV-2 OR New onset or worsening of any one of the following symptoms, which lasts for at least 24 hours, not otherwise explained: headache, malaise, myalgia, chest congestion, cough, runny nose, shortness of breath or difficulty breathing (resting or on exertion), sore throat, wheezing, eye irritation or discharge, chills, fever (≥ 38.0°C or ≥ 100.4°F), pulse oximetry value ≤95% (which is a decrease from baseline), heart rate ≥90 bpm at rest (which is an increase from baseline), GI symptoms, neurologic symptoms, red or bruised looking toes, skin rash, taste loss or new/changing sense of smell, symptoms of blood clots, confusion, bluish lips or face, clinical suspicion or judgement by sponsor-investigator of symptoms suggestive for COVID-19.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start11 Apr 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Why it stopped: Janssen Biotech, Inc stopped production of the vaccine, and it was no longer available as of 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RecipientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Stegall
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor-investigator, Mark Stegall, Mayo Clinic
- Investigators
- Mark D Stegall, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220397
- Sponsor's protocol ID
- 21-008036
- Status last verified
- Sep 2025
- First submitted
- 27 Jan 2022
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40663029
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05220397
- Acronym / sponsor ID
- 21-008036
- Conditions
- Kidney Transplant Recipient
- Keywords
- kidney transplant, renal transplant, COVID-19, COVID-19 vaccine, Janssen Ad26.CoV2.S vaccine, adenovector vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Janssen Biotech, Inc stopped production of the vaccine, and it was no longer available as of 2023.
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Mark StegallUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: Janssen Ad26.CoV2.S VaccineIndividuals 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 |
| Low Level (LL) Spike Antibodies: Janssen Vaccine Non-Responders | Experimental | Biological: Janssen Ad26.CoV2.S VaccineIndividuals 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 |
| Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication | Experimental | Biological: Janssen Ad26.CoV2.S Vaccine, Other: Maintenance in Immunosuppression MedicationIndividuals 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 |
| Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication | Experimental | Biological: Janssen Ad26.CoV2.S Vaccine, Other: Reduction in Immunosuppression MedicationIndividuals 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Janssen Ad26.CoV2.S VaccineSingle dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle | Biological | 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 MedicationReduction in immunosuppression medication dosage | Other | Undetectable Levels (UL) Spike Antibodies: Change Immunosuppression Medication |
| Maintenance in Immunosuppression MedicationMaintain current immunosuppression medication dosage | Other | Undetectable Levels (UL) Spike Antibodies: Maintain Immunosuppression Medication |
Primary outcome
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Low Level Anti-COVID Spike Protein at Enrollment
Time frame: 28 days following first dose of Janssen Ad26.CoV2.S vaccine
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.
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Undetectable Anti-COVID Spike Protein at Enrollment
Time frame: 28 days following first dose of Janssen Ad26.CoV2.S vaccine
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.
3 secondary outcomes
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
Time frame: 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.
Time frame: 2 years
Incidence of COVID-19 Infection
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40663029Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Stegall, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Janssen Ad26.CoV2.S Vaccine, Reduction in Immunosuppression Medication and Maintenance in Immunosuppression Medication in people with Kidney Transplant Recipient, run by Mark Stegall at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to the Janssen Ad26.CoV2.S Vaccine in Subjects With Low Level Anti-COVID Spike Protein at Enrollment (time frame: 28 days following first dose of Janssen Ad26.CoV2.S vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05220397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.