Evidence map›Paper›PMID 39395230›Full record

Trial reportEBioMedicine2024

Real-world assessment of immunogenicity in immunocompromised individuals following SARS-CoV-2 mRNA vaccination: a two-year follow-up of the prospective clinical trial COVAXID.

Puran Chen, Peter Bergman, Ola Blennow, Lotta Hansson, Stephan Mielke, Piotr Nowak, Yu Gao, Gunnar Söderdahl, Anders Österborg, C I Edvard Smith and 13 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in EBioMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04780659 (Immunological Responses After Vaccination for COVID-19 With the Messenger Ribonucleic Acid), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

NCT04780659 phase4completednot on this map

Immunological Responses After Vaccination for COVID-19 With the Messenger Ribonucleic Acid (mRNA) Vaccine Comirnaty in Immunosuppressed and Immunocompetent Individuals. An Open and Non-randomized, Phase IV Multicenter Study

TypeinterventionalSponsorKarolinska University HospitalRan2021 to 2024Enrolled539ConditionsCovid19ArmsComirnaty (COVID-19, mRNA vaccine)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
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  4. Review
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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

23 authors.

Puran ChenDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden.
Peter BergmanDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden; Department of Laboratory Medicine, Clinical Immunology, Karolinska Institutet, Stockholm, Sweden; Department of Clinical Immunology and Transfusion Medicine, Karolinska University Hospital, Stockholm, Sweden.
Ola BlennowDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden; Department of Transplantation, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Lotta HanssonDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden; Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
Stephan MielkeDepartment of Cellular Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center, Stockholm, Sweden; Department of Laboratory Medicine, Biomolecular and Cellular Medicine, Karolinska Institutet, Stockholm, Sweden.
Piotr NowakDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine Huddinge, Infectious Diseases, Karolinska Institutet, Stockholm, Sweden.
Yu GaoDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden.
Gunnar SöderdahlDepartment of Transplantation, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Anders ÖsterborgDepartment of Hematology, Karolinska University Hospital, Stockholm, Sweden; Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
C I Edvard SmithDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden; Department of Laboratory Medicine, Biomolecular and Cellular Medicine, Karolinska Institutet, Stockholm, Sweden.
Jan VesterbackaDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine Huddinge, Infectious Diseases, Karolinska Institutet, Stockholm, Sweden.
David WullimannDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden.
Angelica CuapioDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden.
Mira AkberDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden.
Gordana BogdanovicDept of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden; Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
Sandra MuschiolDept of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden; Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden.
Mikael ÅbergDepartment of Medical Sciences, Clinical Chemistry, Science for Life Laboratory, Uppsala University, Uppsala, Sweden.
Karin LoréDepartment of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Margaret Sällberg ChenDepartment of Laboratory Medicine, Division of Pathology, Karolinska Institutet, Stockholm, Sweden.
Per LjungmanDepartment of Cellular Therapy and Allogeneic Stem Cell Transplantation (CAST), Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center, Stockholm, Sweden; Department of Medicine Huddinge, Division of Hematology, Karolinska Institutet, Stockholm, Sweden.
Marcus BuggertDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden.
Soo AlemanDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine Huddinge, Infectious Diseases, Karolinska Institutet, Stockholm, Sweden. Electronic address: soo.aleman@regionstockholm.se.
Hans-Gustaf LjunggrenDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden. Electronic address: hans-gustaf.ljunggren@ki.se.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmunocompromised patients with primary and secondary immunodeficiencies have shown impaired responses to SARS-CoV-2 mRNA vaccines, necessitating recommendations for additional booster doses. However, longitudinal data reflecting the real-world impact of such recommendations remains limited.

methodsThis study represents a two-year follow-up of the COVAXID clinical trial, where 364 of the original 539 subjects consented to participate. 355 individuals provided blood samples for evaluation of binding antibody (Ab) titers and pseudo-neutralisation capacity against both the ancestral SARS-CoV-2 strain and prevalent Omicron variants. T cell responses were assessed in a subset of these individuals. A multivariate analysis determined the correlation between Ab responses and the number of vaccine doses received, documented infection events, immunoglobulin replacement therapy (IGRT), and specific immunosuppressive drugs. The original COVAXID clinical trial was registered in EudraCT (2021-000175-37) and clinicaltrials.gov (NCT04780659).

findingsSeveral of the patient groups that responded poorly to the initial primary vaccine schedule and early booster doses presented with stronger immunogenicity-related responses including binding Ab titres and pseudo-neutralisation at the 18- and 24-month sampling time point. Responses correlated positively with the number of vaccine doses and infection. The vaccine response was blunted by an immunosuppressive state due to the underlying specific disease and/or to specific immunosuppressive treatment.

interpretationThe study results highlight the importance of continuous SARS-CoV-2 vaccine booster doses in building up and sustaining Ab responses in specific immunocompromised patient populations.

fundingThe present studies were supported by the European Research Council, Karolinska Institutet, Knut and Alice Wallenberg Foundation, Nordstjernan AB, Region Stockholm, and the Swedish Research Council.

Indexed as

Antibodies, ViralCOVID-19COVID-19 VaccinesImmunocompromised HostSARS-CoV-2AdultAgedAntibodies, NeutralizingFemaleFollow-Up StudiesHumansImmunization, SecondaryImmunogenicity, VaccineMaleMiddle AgedmRNA VaccinesAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesmRNA VaccinesChronic lymphocytic leukemiaClinical studyCOVID-19Hematopoietic stem cell transplantationHIVmRNA vaccinePrimary immunodeficiency diseaseSARS-CoV-2Solid organ transplantation

Identifiers

PMID39395230
PMCPMC11663764

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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.