NCT05077254

COVID Protection After Transplant-Immunosuppression Reduction

A Randomized Study to Evaluate Antibody Response to an Additional Dose of SARS-CoV-2 Vaccination With and Without Immunosuppression Reduction in Kidney and Liver Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.

Detailed description

This study is a randomized, open-label multi-site trial designed to induce an enhanced antibody response to severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in kidney and liver transplant recipients who have ≤ 2500 U/mL anti-spike antibody (as measured by the Roche Elecsys® anti-SARS-CoV-2 S assay) after a completed primary series (3 doses) of mRNA COVID-19 vaccines. Participants will be randomized to either: 1. Receive a study dose of mRNA based COVID-19 vaccine (booster) with no change in their immunosuppressive regimen, or 2. Undergo a temporary, prescribed reduction in their maintenance immunosuppression (IS) regimen and receive a study dose (booster) of mRNA based COVID-19 vaccine. Protocol Version 8.0 will include a booster dose of either Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or Moderna COVID-19 Vaccine 2023-2024, with or without IS reduction. Duration of study participation for interested and eligible individuals: 13 months.

Conditions

• Kidney Transplant Recipients
• Liver Transplant Recipients

Interventions

Type	Name	Description
BIOLOGICAL	Pfizer-BioNTech COVID-19 Vaccine 2023-2024	Administration: One dose administered intramuscularly.
BIOLOGICAL	Moderna COVID-19 Vaccine 2023-2024	Administration: One dose administered intramuscularly.
DRUG	SOC IS Regimen	Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
DRUG	SOC IS Reduction	Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.

Timeline

• Start date: 2021-12-06
• Primary completion: 2024-02-28
• Completion: 2025-02-21
• First posted: 2021-10-14
• Last updated: 2026-01-07

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study