Covid-19 Vaccine Response in Heart Transplant Recipients

NCT05268679 | Completed

• 1 other identifier: APHP211456
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Heart transplant recipients; Covid-19 virus infection; SARS-CoV-2 vaccine; Vaccine Effectiveness; Humoral immune response; Cellular Immune Response

Outcome Measures

Primary Outcomes (2)

• Anti-SARS-CoV-2 neutralizing antibody levels

  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

  Search for memory T lymphocytes specific to SARS-CoV-2 using an Elispot interferon γ test during the inclusion visit

  Day 0

Secondary Outcomes (3)

• Efficacy of COVID-19 vaccines against SARS-CoV-2 infection

  Month 6

• Safety of COVID-19 vaccines

  Day 0

• Kinetics of the humoral response

  Change from baseline to month 6

Study Arms (1)

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; Other: Questionnaire; Other: Electronic Health Record Review

Interventions

Biospecimen Collection 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

Heart transplant recipients

Questionnaire OTHER

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

Heart transplant recipients

Electronic Health Record Review OTHER

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

Heart transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Bichat-Claude Bernard Hospital

Paris, 75018, France

Location

Related Publications (2)

• 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.

  PMID: 34034958 BACKGROUND

• 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.

  PMID: 33963635 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Richard DORENT, MD

  AP-HP, Bichat-Claude Bernard Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 7, 2022
• Study Start: March 7, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

FR (1)