Covid-19 Vaccine Response in Heart Transplant Recipients

NCT ID: NCT05268679

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-11-30

Brief 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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Biospecimen Collection

Intervention Type: OTHER

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

Questionnaire

Intervention Type: OTHER

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

Electronic Health Record Review

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Questionnaire

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

Intervention Type: OTHER

Electronic Health Record Review

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard DORENT, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Bichat-Claude Bernard Hospital

Locations

AP-HP, Bichat-Claude Bernard Hospital

Paris, , France

Countries

France

References

Peled Y, Ram E, Lavee J, Sternik L, Segev A, Wieder-Finesod A, Mandelboim M, Indenbaum V, Levy I, Raanani E, Lustig Y, Rahav G. BNT162b2 vaccination in heart transplant recipients: Clinical experience and antibody response. J Heart Lung Transplant. 2021 Aug;40(8):759-762. doi: 10.1016/j.healun.2021.04.003. Epub 2021 Apr 21.

Reference Type: BACKGROUND

PMID: 34034958 (View on PubMed)

Itzhaki Ben Zadok O, Shaul AA, Ben-Avraham B, Yaari V, Ben Zvi H, Shostak Y, Pertzov B, Eliakim-Raz N, Abed G, Abuhazira M, Barac YD, Mats I, Kramer MR, Aravot D, Kornowski R, Ben-Gal T. Immunogenicity of the BNT162b2 mRNA vaccine in heart transplant recipients - a prospective cohort study. Eur J Heart Fail. 2021 Sep;23(9):1555-1559. doi: 10.1002/ejhf.2199. Epub 2021 May 14.

Reference Type: BACKGROUND

PMID: 33963635 (View on PubMed)

Other Identifiers

APHP211456

Identifier Type: -

Identifier Source: org_study_id