Clinical trial NCT05268679: Covid-19 Vaccine Response in Heart Transplant Recipients
Official title: Study of the Humoral and Cellular Response to Vaccines Against SARS-CoV-2 in Heart Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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)

Primary outcomes:
measure: Anti-SARS-CoV-2 neutralizing antibody levels
timeFrame: Change from baseline to month 6
measure: Efficacy of COVID-19 Vaccines against SARS-CoV-2 infection
timeFrame: Day 0
Secondary outcomes:
measure: Efficacy of COVID-19 vaccines against SARS-CoV-2 infection
timeFrame: Month 6
measure: Safety of COVID-19 vaccines
timeFrame: Day 0
measure: Kinetics of the humoral response
timeFrame: Change from baseline to month 6
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Bichat-Claude Bernard Hospital
Study officials:
affiliation: AP-HP, Bichat-Claude Bernard Hospital
name: Richard DORENT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.