Evidence map›Paper›PMID 37659994›Full record

Observational studyClinical and experimental medicine2023

A prospective longitudinal cohort study on risk factors for COVID-19 vaccination failure (RisCoin): methods, procedures and characterization of the cohort.

Sibylle Koletzko, Thu Giang Le Thi, Ana Zhelyazkova, Andreas Osterman, Sven P Wichert, Simone Breiteneicher, Leandra Koletzko, Tobias Schwerd, Stefanie Völk, Tarek Jebrini and 9 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Clinical and experimental medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

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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

19 authors at 4 institutions in 2 countries.

Sibylle KoletzkoDepartment of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Lindwurmstraße 4, 80337, Munich, Germany. sibylle.koletzko@med.uni-muenchen.de.
Thu Giang Le ThiDepartment of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Lindwurmstraße 4, 80337, Munich, Germany.
Ana ZhelyazkovaInstitut für Notfallmedizin und Medizinmanagement (INM), Klinikum der Universität München, LMU München, Munich, Germany.
Andreas OstermanMax von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU Munich, Munich, Germany.
Sven P WichertDepartment of Psychiatry and Psychotherapy, LMU University Hospital, LMU Munich, Nussbaumstraße 7, 80336, Munich, Germany.
Simone BreiteneicherDepartment of Medicine II, LMU University Hospital, LMU Munich, Munich, Germany.
Leandra KoletzkoDepartment of Medicine II, LMU University Hospital, LMU Munich, Munich, Germany.
Tobias SchwerdDepartment of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Lindwurmstraße 4, 80337, Munich, Germany.
Stefanie VölkDepartment of Neurology, LMU University Hospital, LMU Munich, Munich, Germany.
Tarek JebriniDepartment of Psychiatry and Psychotherapy, LMU University Hospital, LMU Munich, Nussbaumstraße 7, 80336, Munich, Germany.
Jeannie HorakDepartment of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Lindwurmstraße 4, 80337, Munich, Germany.
Marina TuschenDepartment of Anesthesiology, Laboratory of Translational Research Stress and Immunity, LMU University Hospital, LMU Munich, Munich, Germany.
Alexander ChoukérDepartment of Anesthesiology, Laboratory of Translational Research Stress and Immunity, LMU University Hospital, LMU Munich, Munich, Germany.
Veit HornungGene Center and Department of Biochemistry, LMU Munich, Munich, Germany.
Oliver T KepplerMax von Pettenkofer Institute and Gene Center, Virology, National Reference Center for Retroviruses, LMU Munich, Munich, Germany.
Berthold KoletzkoDepartment of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU Munich, Lindwurmstraße 4, 80337, Munich, Germany.
Helga P TörökDepartment of Medicine II, LMU University Hospital, LMU Munich, Munich, Germany.
Kristina AdorjanDepartment of Psychiatry and Psychotherapy, LMU University Hospital, LMU Munich, Nussbaumstraße 7, 80336, Munich, Germany. kristina.adorjan@med.uni-muenchen.de.
Members of Riscoin Study Group
LMU Klinikum · DEGerman Center for Infection Research · DELudwig-Maximilians-Universität München · DEUniversity of Warmia and Mazury in Olsztyn · PL

Funding

Bavarian Ministry of Science and Art (Bayerisches Staatsministerium für Wissenschaft und Kunst), Germany, KoCo19-CEDGerman Federal Ministry of Health (Bundesministerium für Gesundheit, BMG), Germany ZMI1-2521COR933-BMGMinistry of Economic and Climate, Germany Action #50WB2222
6 · The paper itself

Abstract

The primary objective of the RisCoin study was to investigate the interplay of genetic, metabolic, and lifestyle factors as well as stress levels on influencing the humoral immune response after at least two COVID-19 vaccinations, primarily with mRNAs, and the risk of SARS-CoV-2 breakthrough infections during follow-up. Here, we describe the study design, procedures, and study population. RisCoin is a prospective, monocentric, longitudinal, observational cohort study. Between October and December 2021, 4515 participants with at least two COVID-19 vaccinations, primarily BNT162b2 and mRNA-1273, were enrolled at the LMU University Hospital of Munich, thereof > 4000 healthcare workers (HCW), 180 patients with inflammatory bowel disease under immunosuppression, and 119 patients with mental disorders. At enrollment, blood and saliva samples were collected to measure anti-SARS-CoV-2 antibodies, their neutralizing capacity against Omicron-BA.1, stress markers, metabolomics, and genetics. To ensure the confidential handling of sensitive data of study participants, we developed a data protection concept and a mobile application for two-way communication. The application allowed continuous data reporting, including breakthrough infections by the participants, despite irreversible anonymization. Up to 1500 participants attended follow-up visits every two to six months after enrollment. The study gathered comprehensive data and bio-samples of a large representative HCW cohort and two patient groups allowing analyses of complex interactions. Our data protection concept combined with the mobile application proves the feasibility of longitudinal assessment of anonymized participants. Our concept may serve as a blueprint for other studies handling sensitive data on HCW.

Indexed as

Breakthrough InfectionsCOVID-19BNT162 VaccineCOVID-19 VaccinesHumansLongitudinal StudiesProspective StudiesRisk FactorsSARS-CoV-2VaccinationBNT162 VaccineCOVID-19 Vaccines

Identifiers

PMID37659994
PMCPMC10725370
OpenAlexW4386388501

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.