TerminatedPhase 3

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

Stopped: Janssen Biotech, Inc stopped production of the vaccine, and it was no longer available as of 2023.

United States468 participantsStarted 2022-04-11

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * 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 co…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

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

Trial details

NCT IDNCT05220397

SponsorMark Stegall

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

Results submitted2025-07-23

View on ClinicalTrials.gov More Kidney Transplant Recipient trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

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