Covid-19 Vaccine Response in Heart Transplant Recipients (COVHEART)

December 30, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Study of the Humoral and Cellular Response to Vaccines Against SARS-CoV-2 in Heart Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In order to evaluate the effectiveness and safety of currently adopted vaccination strategies in heart transplant recipients we intend to study the humoral and cellular responses to SARS-CoV-2 mRNA vaccines in heart transplant recipients followed at Bichat Hospital.

All heart transplant recipients followed at Bichat Hospital will be invited to participate in this research.

The vaccination schedule was 3 doses for the seronegative patients without documented infection, and 2 doses for patients who were seropositive or had a positive Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) test for SARS-CoV-2. Most patients were vaccinated at Bichat Hospital. Their vaccination schedule will be recovered. Some patients refused vaccination.

Since the beginning of 2020, the transplant patients have benefited from systematic serological tests and RT-PCR testing of nasopharyngeal swabs in the event of symptoms suggestive of SARS-CoV-2 infection as part of routine care. The results of these tests will be retrieved from medical records retrospectively in order to investigate the kinetics and durability of the humoral response. Demographic and clinical data will be collected to determine the factors associated with vaccine response.

In addition, a whole blood sample will be drawn at inclusion in order to evaluate cellular response. The patients will be also asked to answer a questionnaire regarding vaccine tolerance.

The effectiveness of vaccination program will be assessed after 6-month follow-up based on the occurrence of SARS-CoV-2 infection, unscheduled medical consultation or hospitalization.

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75018
        • AP-HP, Bichat-Claude Bernard Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Heart transplant recipients followed at Bichat Hospital and who were offered vaccination against SARS-CoV-2, regardless of whether they agreed to be vaccinated or not.

Description

Inclusion Criteria:

  • Heart transplant patients followed at Bichat Hospital
  • Aged 18 or older
  • Informed and having expressed their non-objection to participation in this research
  • Able to give their agreement

Exclusion Criteria:

  • Minors
  • Heart transplant recipients who have expressed their opposition to their participation
  • Legally protected adult
  • Persons under the State Medical Assistance (AME)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart transplant recipients
Heart transplant recipients followed at Bichat Hospital and who were offered vaccination against SARS-CoV-2, regardless of whether they agreed to be vaccinated or not.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-SARS-CoV-2 neutralizing antibody levels
Time Frame: Change from baseline to month 6
Anti-SARS-CoV-2 neutralizing antibody levels over time, with quantification of immunoglobulin G (IgG) directed against the Receptor Binding Domain (RBD) of the Spike (S) protein
Change from baseline to month 6
Efficacy of COVID-19 Vaccines against SARS-CoV-2 infection
Time Frame: Day 0
Search for memory T lymphocytes specific to SARS-CoV-2 using an Elispot interferon γ test during the inclusion visit
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of COVID-19 vaccines against SARS-CoV-2 infection
Time Frame: Month 6
Proportion of vaccinated heart transplant recipients having had an infection documented by RT-PCR and a serious infection requiring hospitalisation
Month 6
Safety of COVID-19 vaccines
Time Frame: Day 0
Patients will be asked to complete the Vaccine tolerance questionnaire where they will asses and evaluate their symptoms. These will include Diffuse muscle pain (on a scale of 10)/ Headache (on a scale of 10)/ Digestive disorders/ Skin rash/ Pain at the injection site (on a scale of 10)/ Fever/ Fatigue/ Other. Lower scores for all symptoms would indicate a better tolerance.
Day 0
Kinetics of the humoral response
Time Frame: Change from baseline to month 6
Change in SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series
Change from baseline to month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Richard DORENT, MD, AP-HP, Bichat-Claude Bernard Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 30, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP211456

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Transplantation

Clinical Trials on Biospecimen Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe