NCT05220397

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: Mark Stegall · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant Recipient

Interventions

Type	Name	Description
BIOLOGICAL	Janssen Ad26.CoV2.S Vaccine	Single dose vaccine of 0.5 mL administered via intramuscular injection, typically in the deltoid muscle
OTHER	Reduction in Immunosuppression Medication	Reduction in immunosuppression medication dosage
OTHER	Maintenance in Immunosuppression Medication	Maintain current immunosuppression medication dosage

Timeline

• Start date: 2022-04-11
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2022-02-02
• Last updated: 2025-09-15
• Results posted: 2025-09-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study