Evidence map›Paper›PMID 34241676›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2021

Poor humoral and T-cell response to two-dose SARS-CoV-2 messenger RNA vaccine BNT162b2 in cardiothoracic transplant recipients.

René Schramm, Angelika Costard-Jäckle, Rasmus Rivinius, Bastian Fischer, Benjamin Müller, Udo Boeken, Assad Haneya, Zdenek Provaznik, Cornelius Knabbe, Jan Gummert

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05280158 (Phase I/II, Open-Label Dose-Finding Trial of High-Dose mRNA-1273 Booster for Lung Transplant Recipients), which is not on this map. Cited by 60 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 9 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05280158 phase1 / phase2terminatednot on this mapstarted 2022, after this paper: background citation

Phase I/II, Open-Label Dose-Finding Trial of High-Dose mRNA-1273 Booster for Lung Transplant Recipients

TypeinterventionalSponsorUniversity of California, Los AngelesRan2022 to 2023Enrolled19ConditionsLung Transplant Recipient, SARS-CoV-2, ImmunosuppressionArmsmRNA-1273 (Moderna COVID-19 vaccine)
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 9 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Immunogenicity of COVID-19 vaccines in solid organ transplant recipients: a systematic review and meta-analysis.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023
    Pooled it
  2. Humoral and cellular response of COVID-19 vaccine among solid organ transplant recipients: A systematic review and meta-analysis.Transplant infectious disease : an official journal of the Transplantation Society · 2022
    Pooled it
  3. Pooled it
  4. COVID-19 and solid organ transplantation: Finding the right balance.Transplantation reviews (Orlando, Fla.) · 2022
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Immunological and clinical efficacy of COVID-19 vaccines in immunocompromised populations: a systematic review.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022
    Pooled it
  10. Trial
  11. Review
  12. Article
  13. Article
  14. How does geographical diversity shape vaccine efficacy?Clinical and experimental vaccine research · 2024
    Review
  15. Article
  16. Article
  17. Third dose of the BNT162b2 vaccine in cardiothoracic transplant recipients: predictive factors for humoral response.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

René Schramm *Klinik für Thorax- und Kardiovaskularchirurgie, Herz und Diabeteszentrum NRW, Universitätsklinik, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
Angelika Costard-Jäckle *Klinik für Thorax- und Kardiovaskularchirurgie, Herz und Diabeteszentrum NRW, Universitätsklinik, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany. Ajaeckle@hdz-nrw.de.ORCID http://orcid.org/0000-0003-1464-239X
Rasmus RiviniusKlinik für Kardiologie, Angiologie Und Pneumologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 672, 69120, Heidelberg, Germany.
Bastian FischerInstitut für Transfusions- Und Labormedizin, Herz Und Diabeteszentrum NRW, Universitätsklinik, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
Benjamin MüllerInstitut für Transfusions- Und Labormedizin, Herz Und Diabeteszentrum NRW, Universitätsklinik, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
Udo BoekenKlinik für Herzchirurgie, Universitätsklinikum Düsseldorf, Heinrich Heine Universität Düsseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
Assad HaneyaKlinik für Herznahe- und Gefäßchirurgie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, 24105, Kiel, Germany.
Zdenek ProvaznikKlinik für Herz-, Thorax- Und Herznahe Gefäßchirurgie, Universitätsklinikum Regensburg, Franz-Josef-Strauß-Allee 11, 93053, Regensburg, Germany.
Cornelius Knabbe *Institut für Transfusions- Und Labormedizin, Herz Und Diabeteszentrum NRW, Universitätsklinik, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
Jan Gummert *Klinik für Thorax- und Kardiovaskularchirurgie, Herz und Diabeteszentrum NRW, Universitätsklinik, Ruhr-Universität Bochum, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
Heart and Diabetes Center North Rhine-Westphalia · DEDüsseldorf University Hospital · DEHeidelberg University · DEUniversity Hospital Regensburg · DEUniversity Hospital Schleswig-Holstein · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsImmunocompromised patients have been excluded from studies of SARS-CoV-2 messenger RNA vaccines. The immune response to vaccines against other infectious agents has been shown to be blunted in such patients. We aimed to analyse the humoral and cellular response to prime-boost vaccination with the BNT162b2 vaccine (Pfizer-BioNTech) in cardiothoracic transplant recipients. METHODS AND

resultsA total of 50 transplant patients [1-3 years post heart (42), lung (7), or heart-lung (1) transplant, mean age 55 ± 10 years] and a control group of 50 healthy staff members were included. Blood samples were analysed 21 days after the prime and the boosting dose, respectively, to quantify anti-SARS-CoV-2 spike protein (S) immunoglobulin titres (tested by Abbott, Euroimmun and RocheElecsys Immunoassays, each) and the functional inhibitory capacity of neutralizing antibodies (Genscript). To test for a specific T-cell response, heparinized whole blood was stimulated with SARS-CoV-2 specific peptides, covering domains of the viral spike, nucleocapsid and membrane protein, and the interferon-γ release was measured (QuantiFERON Monitor ELISA, Qiagen). The vast majority of transplant patients (90%) showed neither a detectable humoral nor a T-cell response three weeks after the completed two-dose BNT162b2 vaccination; these results are in sharp contrast to the robust immunogenicity seen in the control group: 98% exhibited seroconversion after the prime dose already, with a further significant increase of IgG titres after the booster dose (average > tenfold increase), a more than 90% inhibition capability of neutralizing antibodies as well as evidence of a T-cell responsiveness.

conclusionsThe findings of poor immune responses to a two-dose BNT162b2 vaccination in cardiothoracic transplant patients have a significant impact for organ transplant recipients specifically and possibly for immunocompromised patients in general. It urges for a review of future vaccine strategies in these patients.

Indexed as

Immunogenicity, VaccineAdolescentAdultAgedAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineCase-Control StudiesCOVID-19COVID-19 VaccinesFemaleHeart-Lung TransplantationHeart TransplantationHumansImmunity, CellularImmunity, HumoralAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesImmunosuppressive AgentsBioNTech/Pfizer (BNT162b2) vaccineCovid-19 infectionImmunocompromised patientsImmunogenicityTransplant recipients

Identifiers

PMID34241676
PMCPMC8267767
OpenAlexW3181407527

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.