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Covid-19 Vaccine Response in Heart Transplant Recipients

NCT05268679 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2024-01-03

No results posted yet for this study

Summary

Clinical studies indicate a decrease in vaccine efficacy in certain immunocompromised populations (kidney transplant recipients, patients undergoing chemotherapy). It was recently reported that only 18% to 49% of heart transplant recipients developed antibodies after 2 doses of BNT162b2 vaccine. Following the published results, it is currently recommended to use 3 doses in organ transplant recipients who have not contracted COVID-19 and 2 doses in those who have been infected. The effectiveness of this strategy is not yet sufficiently evaluated in heart transplant recipients. Moreover, the factors associated with the humoral and cellular response, the kinetics and durability of the humoral response, the occurrence of the cellular immune response and the tolerance of the vaccine are not well known in this population.

To provide answers to these different questions, we set ourselves the objective of evaluating the humoral and cellular response to messenger RNA (mRNA) vaccines in heart transplant recipients followed at Bichat Hospital.

Conditions

  • Heart Transplantation
  • COVID-19 Virus Infection
  • COVID-19 Vaccine

Interventions

OTHER

Biospecimen Collection

A blood of a sample of 2 x 7 mL will be collected for the analysis of the anti-SARS-CoV-2 T-cell response during a scheduled check-up as part of their routine follow-up

OTHER

Questionnaire

Patients who have received SARS-CoV-2 vaccination will be asked to complete the Vaccine tolerance questionnaire

OTHER

Electronic Health Record Review

For heart transplant recipients who were offered vaccination against SARS-CoV-2 medical records will be reviewed retrospectively.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Richard DORENT, MD · AP-HP, Bichat-Claude Bernard Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • France

Study Locations

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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 NCT05268679 on ClinicalTrials.gov