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

NCT05220397 ↗

Phase 3 Terminated 468 enrolled Mark Stegall Janssen Scientific Affairs, LLC · collab

RandomizedFactorialOpen-labelPrevention

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).

Timeline

Start: 2022-04-11
Primary completion: 2025-02-28
Completion: 2025-02-28

Outcome

Outcome not reported

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

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Janssen Ad26.CoV2.S Vaccine	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.