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Heart TransplantationCOVHEARTNCT05268679

Covid-19 Vaccine Response in Heart Transplant Recipients

An observational study of Heart Transplantation and COVID-19 Virus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Questionnaire and Electronic Health Record Review
Type of treatment
Vaccines
How many people
190 participants
Where
1 siteFrance
Study dates
7 Mar 2022to 30 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • AP-HP, Bichat-Claude Bernard Hospital

    Paris, 75018

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Biospecimen Collection, Questionnaire, Electronic Health Record Review
Keywords
Heart transplant recipients, Covid-19 virus infection, SARS-CoV-2 vaccine, Vaccine Effectiveness, Humoral immune response, Cellular Immune Response
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionOther

    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

  • QuestionnaireOther

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

  • Electronic Health Record ReviewOther

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

Study groups in NCT05268679
Study groupRoleWhat they receive
Heart transplant recipientsHeart 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.
Receives: Other: Biospecimen Collection; Other: Questionnaire; Other: Electronic Health Record Review

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from baseline to month 6

  2. 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

    Measured: Day 0

Secondary outcomes (3)

  1. Efficacy of COVID-19 vaccines against SARS-CoV-2 infection

    Proportion of vaccinated heart transplant recipients having had an infection documented by RT-PCR and a serious infection requiring hospitalisation

    Measured: Month 6

  2. Safety of COVID-19 vaccines

    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.

    Measured: Day 0

  3. Kinetics of the humoral response

    Change in SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series

    Measured: Change from baseline to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start7 Mar 2022
  3. Primary completion30 Nov 2022
  4. Study completion30 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05268679
Sponsor's protocol ID
APHP211456
Acronym
COVHEART
Status last verified
Dec 2023
First submitted
4 Mar 2022
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34034958

  • 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.

    PubMed 33963635

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Transplantation and COVID-19 Virus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-SARS-CoV-2 neutralizing antibody levels (time frame: Change from baseline to month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05268679, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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