Publications

Inability to work following COVID-19 vaccination-a relevant aspect for future booster vaccinations.

Abstract (Expand)

OBJECTIVES: COVID-19 vaccination is a key prevention strategy to reduce the spread and severity of SARS-CoV-2 infections. However, vaccine-related inability to work among healthcare workers (HCWs) could … overstrain healthcare systems. STUDY DESIGN: The study presented was conducted as part of the prospective CoVacSer cohort study. METHODS: This study examined sick leave and intake of pro re nata medication after the first, second, and third COVID-19 vaccination in HCWs. Data were collected by using an electronic questionnaire. RESULTS: Among 1704 HCWs enrolled, 595 (34.9%) HCWs were on sick leave following at least one COVID-19 vaccination, leading to a total number of 1550 sick days. Both the absolute sick days and the rate of HCWs on sick leave significantly increased with each subsequent vaccination. Comparing BNT162b2mRNA and mRNA-1273, the difference in sick leave was not significant after the second dose, but mRNA-1273 induced a significantly longer and more frequent sick leave after the third. CONCLUSION: In the light of further COVID-19 infection waves and booster vaccinations, there is a risk of additional staff shortages due to postvaccination inability to work, which could negatively impact the already strained healthcare system and jeopardise patient care. These findings will aid further vaccination campaigns to minimise the impact of staff absences on the healthcare system.

Authors: J. Reusch, I. Wagenhauser, A. Gabel, A. Hohn, T. T. Lam, L. B. Krone, A. Frey, A. Schubert-Unkmeir, L. Dolken, S. Frantz, O. Kurzai, U. Vogel, M. Krone, N. Petri

Date Published: 25th Aug 2023

Publication Type: Journal

Influencing factors of anti-SARS-CoV-2-spike-IgG antibody titers in healthcare workers: A cross-section study.

Abstract (Expand)

Against the background of the current COVID-19 infection dynamics with its rapid spread of SARS-CoV-2 variants of concern (VOC), the immunity and the vaccine prevention of healthcare workers (HCWs) … against SARS-CoV-2 continues to be of high importance. This observational cross-section study assesses factors influencing the level of anti-SARS-CoV-2-spike IgG after SARS-CoV-2 infection or vaccination. One thousand seven hundred and fifty HCWs were recruited meeting the following inclusion criteria: age >/=18 years, PCR-confirmed SARS-CoV-2 infection convalescence and/or at least one dose of COVID-19 vaccination. anti-SARS-CoV-2-spike IgG titers were determined by SERION ELISA agile SARS-CoV-2 IgG. Mean anti-SARS-CoV-2-spike IgG levels increased significantly by number of COVID-19 vaccinations (92.2 BAU/ml for single, 140.9 BAU/ml for twice and 1144.3 BAU/ml for threefold vaccination). Hybrid COVID-19 immunized respondents (after infection and vaccination) had significantly higher antibody titers compared with convalescent only HCWs. Anti-SARS-CoV-2-spike IgG titers declined significantly with time after the second vaccination. Smoking and high age were associated with lower titers. Both recovered and vaccinated HCWs presented a predominantly good humoral immune response. Smoking and higher age limited the humoral SARS-CoV-2 immunity, adding to the risk of severe infections within this already health impaired collective.

Authors: J. Reusch, I. Wagenhauser, A. Gabel, A. Eggestein, A. Hohn, T. T. Lam, A. Frey, A. Schubert-Unkmeir, L. Dolken, S. Frantz, O. Kurzai, U. Vogel, M. Krone, N. Petri

Date Published: 13th Nov 2022

Publication Type: Journal

The relationship between mental health, sleep quality and the immunogenicity of COVID-19 vaccinations.

Abstract (Expand)

Sleep modulates the immune response, and sleep loss can reduce vaccine immunogenicity; vice versa, immune responses impact sleep. We aimed to investigate the influence of mental health and sleep quality … on the immunogenicity of COVID-19 vaccinations and, conversely, of COVID-19 vaccinations on sleep quality. The prospective CoVacSer study monitored mental health, sleep quality and Anti-SARS-CoV-2-Spike IgG titres in a cohort of 1082 healthcare workers from 29 September 2021 to 19 December 2022. Questionnaires and blood samples were collected before, 14 days, and 3 months after the third COVID-19 vaccination, as well as in 154 participants before and 14 days after the fourth COVID-19 vaccination. Healthcare workers with psychiatric disorders had slightly lower Anti-SARS-CoV-2-Spike IgG levels before the third COVID-19 vaccination. However, this effect was mediated by higher median age and body mass index in this subgroup. Antibody titres following the third and fourth COVID-19 vaccinations ("booster vaccinations") were not significantly different between subgroups with and without psychiatric disorders. Sleep quality did not affect the humoral immunogenicity of the COVID-19 vaccinations. Moreover, the COVID-19 vaccinations did not impact self-reported sleep quality. Our data suggest that in a working population neither mental health nor sleep quality relevantly impact the immunogenicity of COVID-19 vaccinations, and that COVID-19 vaccinations do not cause a sustained deterioration of sleep, suggesting that they are not a precipitating factor for insomnia. The findings from this large-scale real-life cohort study will inform clinical practice regarding the recommendation of COVID-19 booster vaccinations for individuals with mental health and sleep problems.

Authors: I. Wagenhauser, J. Reusch, A. Gabel, J. Mees, H. Nyawale, A. Frey, T. T. Lam, A. Schubert-Unkmeir, L. Dolken, O. Kurzai, S. Frantz, N. Petri, M. Krone, L. B. Krone

Date Published: 14th May 2024

Publication Type: Journal

Determinants of Influenza A infection rate in post-COVID-19 era.

Abstract

Not specified

Authors: I. Wagenhauser, J. Mees, J. Reusch, T. T. Lam, A. Schubert-Unkmeir, L. B. Krone, A. Frey, O. Kurzai, S. Frantz, L. Dolken, J. Liese, A. Gabel, N. Petri, M. Krone

Date Published: 11th Sep 2023

Publication Type: Journal

Heterologous and homologous COVID-19 mRNA vaccination schemes for induction of basic immunity show similar immunogenicity regarding long-term spike-specific cellular immunity in healthcare workers.

Abstract (Expand)

Healthcare workers (HCWs) are recommended to receive at least three spike-antigen exposures to generate basic immunity and to mediate herd protection of vulnerable patients. So far, less attention has … been put on the cellular immune response induced by homologous (three BTN162b2mRNA doses) or heterologous (mRNA-1273 as third dose building on two BTN162bmRNA doses) and the immunological impact of breakthrough infections (BTIs). Therefore, in 356 vaccinated HCWs with or without BTIs the Anti-SARS-CoV-2-Spike-IgG concentrations and avidities and B- and T-cell-reactivity against SARS-CoV-2-Spike-S1- and Nucleocapsid-antigens were assessed with Interferon-gamma-ELISpot and by flow-cytometry. HCWs who had hybrid immunity due to BTIs exhibited strong T-cell-reactivity against the Spike-S1-antigen. A lasso regression model revealed a significant reduction in T-cell immune responses among smokers (p < 0.0001), with less significant impact observed for age, sex, heterologous vaccination, body-mass-index, Anti-Nucleocapsid T-cell reactivity, days since last COVID-19-immunization, and Anti-SARS-CoV-2-Spike-IgG. Although subgroup analysis revealed higher Anti-SARS-CoV-2-Spike-IgG after heterologous vaccination, similar cellular reactivity and percentages of Spike-reactive T- and B-cells were found between homologous and heterologous vaccination. Anti-SARS-CoV-2-Spike-IgG concentrations and avidity significantly correlated with activated T-cells. CD4 + and CD8 + responses correlated with each other. A strong long-term cellular immune response should be considered as baseline for recommendations of booster doses in HCWs with prioritization of smokers. HCWs presented significant T-cellular reactivity towards Spike-S1-antigen with particularly strong responses in hybrid immunized HCWs who had BTIs. HCWs without BTI presented similar percentages of Spike-specific B- and T-cells between homologous or heterologous vaccination indicating similar immunogenicity for both mRNA vaccines, BNT162b2mRNA and mRNA-1273.

Authors: I. Wagenhauser, G. Almanzar, F. B. Forg, A. Stein, I. Eiter, J. Reusch, J. Mees, A. Herzog, U. Vogel, A. Frey, T. T. Lam, A. Schubert-Unkmeir, L. Dolken, O. Kurzai, S. Frantz, A. Gabel, N. Petri, M. Prelog, M. Krone

Date Published: 30th Aug 2024

Publication Type: Journal

Bivalent BNT162b2 mRNA original/omicron BA.4-5 booster vaccination: adverse reactions and inability to work compared with the monovalent COVID-19 booster.

Abstract

Not specified

Authors: I. Wagenhauser, J. Reusch, A. Gabel, L. B. Krone, O. Kurzai, N. Petri, M. Krone

Date Published: 4th Apr 2023

Publication Type: Journal

Immunogenicity and safety of coadministration of COVID-19 and influenza vaccination.

Abstract (Expand)

Coadministration of seasonal quadrivalent influenza and COVID-19 booster vaccination is safe and does not increase vaccine-related side-effects, but may limit anti-SARS-CoV-2 antibody formation … https://bit.ly/3uKFUie

Authors: I. Wagenhauser, J. Reusch, A. Gabel, A. Hohn, T. T. Lam, G. Almanzar, M. Prelog, L. B. Krone, A. Frey, A. Schubert-Unkmeir, L. Dolken, S. Frantz, O. Kurzai, U. Vogel, N. Petri, M. Krone

Date Published: 23rd Dec 2022

Publication Type: Journal

SARS-CoV-2 antigen rapid detection tests: test performance during the COVID-19 pandemic and the impact of COVID-19 vaccination.

Abstract (Expand)

BACKGROUND: SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics alongside reverse transcription polymerase chain reaction (RT-qPCR) as reference. METHODS: In a prospective … performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital, the sensitivity and specificity (primary endpoints) of RDTs from three manufacturers (NADAL(R), Panbio, MEDsan(R)) were compared to RT-qPCR as reference standard among patients, accompanying persons and staff aged >/= six month in large-scale, clinical screening use. Regression models were used to assess influencing factors on RDT performance (secondary endpoints). FINDINGS: Among 78,798 paired RDT/RT-qPCR results analysed, overall RDT sensitivity was 34.5% (695/2016; 95% CI 32.4-36.6%), specificity 99.6% (76,503/76,782; 95% CI 99.6-99.7%). Over the pandemic course, sensitivity decreased in line with a lower rate of individuals showing typical COVID-19 symptoms. The lasso regression model showed that a higher viral load and typical COVID-19 symptoms were directly significantly correlated with the likelihood of a positive RDT result in SARS-CoV-2 infection, whereas age, sex, vaccination status, and the Omicron VOC were not. INTERPRETATION: The decline in RDT sensitivity throughout the pandemic can primarily be attributed to the reduced prevalence of symptomatic infections among vaccinated individuals and individuals infected with Omicron VOC. RDTs remain valuable for detecting SARS-CoV-2 in symptomatic individuals and offer potential for detecting other respiratory pathogens in the post-pandemic era, underscoring their importance in infection control efforts. FUNDING: German Federal Ministry of Education and Research (BMBF), Free State of Bavaria, Bavarian State Ministry of Health and Care.

Authors: I. Wagenhauser, K. Knies, T. Pscheidl, M. Eisenmann, S. Flemming, N. Petri, M. McDonogh, A. Scherzad, D. Zeller, A. Gesierich, A. K. Seitz, R. Taurines, R. I. Ernestus, J. Forster, D. Weismann, B. Weissbrich, J. Liese, C. Hartel, O. Kurzai, L. Dolken, A. Gabel, M. Krone

Date Published: 9th Oct 2024

Publication Type: Journal

Virus variant-specific clinical performance of SARS coronavirus two rapid antigen tests in point-of-care use, from November 2020 to January 2022.

Abstract (Expand)

OBJECTIVES: Antigen rapid diagnostic tests (RDTs) for SARS coronavirus 2 (SARS-CoV-2) are quick, widely available, and inexpensive. Consequently, RDTs have been established as an alternative and … additional diagnostic strategy to quantitative reverse transcription polymerase chain reaction (RT-qPCR). However, reliable clinical and large-scale performance data specific to a SARS-CoV-2 virus variant of concern (VOC) are limited, especially for the Omicron VOC. The aim of this study was to compare RDT performance among different VOCs. METHODS: This single-centre prospective performance assessment compared RDTs from three manufacturers (NADAL, Panbio, MEDsan) with RT-qPCR including deduced standardized viral load from oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting from November 2020 to January 2022. RESULTS: Among 35 479 RDT/RT-qPCR tandems taken from 26 940 individuals, 164 of the 426 SARS-CoV-2 positive samples tested true positive with an RDT corresponding to an RDT sensitivity of 38.50% (95% CI, 34.00-43.20%), with an overall specificity of 99.67% (95% CI, 99.60-99.72%). RDT sensitivity depended on viral load, with decreasing sensitivity accompanied by descending viral load. VOC-dependent sensitivity assessment showed a sensitivity of 42.86% (95% CI, 32.82-53.52%) for the wild-type SARS-CoV-2, 43.42% (95% CI, 32.86-54.61%) for the Alpha VOC, 37.67% (95% CI, 30.22-45.75%) for the Delta VOC, and 33.67% (95% CI, 25.09-43.49%) for the Omicron VOC. Sensitivity in samples with high viral loads of >/=10(6) SARS-CoV-2 RNA copies per mL was significantly lower in the Omicron VOC (50.00%; 95% CI, 36.12-63.88%) than in the wild-type SARS-CoV-2 (79.31%; 95% CI, 61.61-90.15%; p 0.015). DISCUSSION: RDT sensitivity for detection of the Omicron VOC is reduced in individuals infected with a high viral load, which curtails the effectiveness of RDTs. This aspect furthert: limits the use of RDTs, although RDTs are still an irreplaceable diagnostic tool for rapid, economic point-of-care and extensive SARS-CoV-2 screening.

Authors: I. Wagenhauser, K. Knies, D. Hofmann, V. Rauschenberger, M. Eisenmann, J. Reusch, A. Gabel, S. Flemming, O. Andres, N. Petri, M. S. Topp, M. Papsdorf, M. McDonogh, R. Verma-Fuhring, A. Scherzad, D. Zeller, H. Bohm, A. Gesierich, A. K. Seitz, M. Kiderlen, M. Gawlik, R. Taurines, T. Wurmb, R. I. Ernestus, J. Forster, D. Weismann, B. Weissbrich, L. Dolken, J. Liese, L. Kaderali, O. Kurzai, U. Vogel, M. Krone

Date Published: 27th Aug 2022

Publication Type: Journal

Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR.

Abstract (Expand)

BACKGROUND: Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data from large field studies is sparse. METHODS: … In a prospective performance evaluation study, RDT from three manufacturers (NADAL(R), Panbio, MEDsan(R), conducted on different samples) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardised RT-qPCR Cycle threshold (C(t)) values. The data collection period ranged from November 12, 2020 to February 28, 2021. FINDINGS: The sensitivity of RDT compared to RT-qPCR was 42.57% (95% CI 33.38%-52.31%). The specificity was 99.68% (95% CI 99.48%-99.80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of >/=10(8) SARS-CoV-2 RNA copies per ml to 8.82% in samples with a viral load lower than 10(4) SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98.84%; the PPV in persons with typical COVID-19 symptoms was 97.37%, and 28.57% in persons without or with atypical symptoms. INTERPRETATION: RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available. FUNDING: German Federal Ministry for Education and Science (BMBF), Free State of Bavaria.

Authors: I. Wagenhauser, K. Knies, V. Rauschenberger, M. Eisenmann, M. McDonogh, N. Petri, O. Andres, S. Flemming, M. Gawlik, M. Papsdorf, R. Taurines, H. Bohm, J. Forster, D. Weismann, B. Weissbrich, L. Dolken, J. Liese, O. Kurzai, U. Vogel, M. Krone

Date Published: 30th Jun 2021

Publication Type: Journal

The Sensitivity of Rapid Tests for SARS-CoV-2 Antigen.

Abstract

Not specified

Authors: K. Knies, I. Wagenhauser, D. Hofmann, V. Rauschenberger, M. Eisenmann, J. Reusch, S. Flemming, O. Andres, N. Petri, M. S. Topp, M. Papsdorf, M. McDonogh, R. Verma-Fuhring, A. Scherzad, D. Zeller, H. Bohm, A. Gesierich, A. K. Seitz, M. Kiderlen, M. Gawlik, R. Taurines, T. Wurmb, R. I. Ernestus, J. Forster, D. Weismann, B. Weissbrich, J. Liese, U. Vogel, O. Kurzai, L. Dolken, A. Gabel, M. Krone

Date Published: 10th Nov 2023

Publication Type: Journal

Clinical accuracy of SARS-CoV-2 rapid antigen testing in screening children and adolescents.

Abstract

Not specified

Authors: M. Krone, I. Wagenhauser, K. Knies, D. Hofmann, G. Engels, R. Taurines, M. McDonogh, S. Flemming, T. Meyer, H. Bohm, A. Scherzad, M. Eisenmann, V. Rauschenberger, A. Gabel, N. Petri, J. Reusch, J. Forster, B. Weissbrich, L. Dolken, O. Kurzai, U. Vogel, C. Hartel, J. Liese, O. Andres

Date Published: 25th Dec 2022

Publication Type: Journal

Ralstonia pickettii bloodstream infections with potential genomic link to internationally distributed contaminated saline solution, Germany, October 2023.

Abstract (Expand)

Ralstonia pickettii is a Gram-negative rod which may cause invasive infections when they contaminate liquid medical products. After R. pickettii was detected in blood cultures and a stem cell product … from three patients in a tertiary care hospital in Germany, whole genome sequencing of these three isolates and two water isolates from the environment was performed. Core genome multilocus sequence typing analysis showed that the three patient isolates were closely related and there was a large distance to the environmental isolates. In a genomic comparison, the patients' isolates were distantly related to an R. pickettii strain from a cluster in Australia suspected to be caused by contaminated saline produced in India, while all liquid medical products with a link to all patients were produced in Europe or the United States. Our data point towards an ongoing risk by an unknown common source that could be traced back to medical products contaminated with R. pickettii and potentially distributed worldwide. Investigating invasive R. pickettii infections, identifying and testing medical products administered to the patients and timely whole genome sequencing may help identify the exact source of this potentially global outbreak.

Authors: M. Krone, V. Rauschenberger, V. Blaschke, H. Claus, O. Kurzai, S. Kampmeier

Date Published: 22nd Jan 2024

Publication Type: Journal

Vaccination status of patients with primary immunodeficiencies in Germany-a multicentric epidemiologic analysis.

Abstract (Expand)

BACKGROUND: Vaccinations represent an easily accessible, safe, and important method for preventing infections. Patients with primary immunodeficiencies (PID) are more susceptible to infections and … should receive an extended spectrum of immunizations in many countries. METHODS: Between January 2019 and May 2020, vaccination certificates of 70 patients with PID from the regions of Wurzburg and Hanover in Germany were evaluated. The patients were additionally surveyed regarding their attitude towards vaccinations and the communication with their physicians. Medical records were analyzed. RESULTS: Of the 70 patients, 54 (77%) suffered from common variable immunodeficiency, 30 (43%) were diagnosed with accompanying autoimmunity, 62 (89%) had an increased susceptibility to infections, and 56 (80%) were on immunoglobulin substitution therapy. Seven patients (10%) had neither a vaccination certificate nor were they able to recollect of their last vaccination. Only 55 (79%) and 43 (61%) patients stated that their rheumatologist or immunologist had recommended an influenza and a pneumococcal vaccination, respectively. When asked about their overall trust in vaccinations on a scale of 0 to 10 (0 = very low, 10 = very high), the mean value was 7.8. The most common vaccination was against tetanus in 63 (90%) patients, 49 (70%) had received vaccination against pneumococci, and 39 (56%) had received an influenza vaccination. Interestingly, 26 patients (37%) were vaccinated against measles, even though this is contraindicated in most PID patients. CONCLUSION: Our data suggest that vaccination rates in this at-risk population are insufficient. Healthcare providers should emphasize vaccinations routinely when caring for these patients.

Authors: E. C. Schwaneck, A. S. Harasim, H. P. Tony, M. Gawlik, T. Witte, S. Joos, M. Gernert, M. Schmalzing, H. Morbach, M. Frohlich, M. Krone

Date Published: 22nd Aug 2024

Publication Type: Journal

Use of Complementary and Alternative Medicine in Patients with Primary Immunodeficiency: a Multicentric Analysis of 101 Patients.

Abstract (Expand)

The term complementary and alternative medicine (CAM) describes a broad spectrum of health care practices that are not an integral part of the conventional health care system. Many patients worldwide … use CAM on their own initiative, often in combination with their conventional medical therapy. CAM use is attractive especially to patients with primary immunodeficiency, since they suffer from frequent infections and autoimmunity. Those are frequently addressed by CAM providers. The aim of this multicentric study was to collect information on the use of CAM by these patients and to define characteristics that are associated with the use of CAM. A total of 101 patients with primary immunodeficiencies at German hospitals were surveyed on their CAM use (further 14 patients rejected to participate). Multiple psychological tests (MARS-D, WHO-5, PHQ9, EFQ) were conducted to investigate variations among personality traits associated with CAM use. Additionally, clinical and sociodemographic patient data was collected. A total of 72% of patients used CAM to treat their primary immunodeficiency. The three most frequently used methods were physical exercise or fitness training (65%), dietary supplements (58%), and homeopathy (49%). Most patients did not discuss CAM use with their doctors, mostly because they felt that there was no time for it. CAM plays an important role for patients with primary immunodeficiency in a high-resource health care setting such as Germany. In clinical practice, doctors should create a platform to discuss needs that go beyond conventional therapy.

Authors: A. S. Harasim, M. Krone, H. P. Tony, M. Gawlik, T. Witte, S. Joos, M. Gernert, M. Schmalzing, H. Morbach, E. C. Schwaneck

Date Published: 7th Jan 2021

Publication Type: Journal

Establishing semi-automated infection surveillance in obstetrics and gynaecology

Abstract

Not specified

Authors: H. Hill, I. Wagenhäuser, P. Schuller, J. Diessner, M. Eisenmann, S. Kampmeier, U. Vogel, A. Wöckel, M. Krone

Date Published: 1st Apr 2024

Publication Type: Journal

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