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Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response

NCT04961229 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2021-10-08

No results posted yet for this study

Summary

Introduction: Inadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients.

Methods and analysis: BECAME is a single center, open label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participant per arm will be also teste for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among \~350 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial.

Ethics and dissemination: The trial is approved by local ethics committee of Rabin medical center (RMC-0192- 21). Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee.

Conditions

  • COVID-19 Acute Respiratory Distress Syndrome
  • Immunosuppression

Interventions

BIOLOGICAL

The Pfizer mRNA-based BNT162b2 vaccine

participants who gave informed consent to participate in either the prospective non-randomised study or RCT will receive a single vaccine dose. In addition, participants in the RCT will be randomised into two groups: 1. Third booster dose of BNT162b2 (one standard dose) with no change in immunosuppression protocol 2. Third booster dose of BNT162b2 (one standard dose) with immunosuppression reduction according to protocol (mycophenolic temporary cessation 4 days before (5 half-lives) and one week (expected antibody response) after vaccination (to allow for antibody response).

Sponsors & Collaborators

  • dafna yahav

    lead OTHER

Principal Investigators

  • Ruth Rahaminov · Rabin Medical Center, Beilinson Campus, Petah-Tikva, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-02-28
Completion
2022-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04961229 on ClinicalTrials.gov