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NCT Number: NCT05268679

Covid-19 Vaccine Response 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.

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Key information

Conditions

Heart Transplantation COVID-19 COVID-19 Vaccine COVID-19 Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Bichat-Claude Bernard Hospital

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Questionnaire

Other

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

Electronic Health Record Review

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: COVHEART

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2022
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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