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Acute Respiratory Infection Protection- Incidence, risk factors and vaccine preventability of acute respiratory infections and their impact on quality of life, work ability and absence from work

Organizational Data

DRKS-ID:
DRKS00033415
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2024-02-23
Last update in DRKS:
2024-04-15
Registration type:
Prospective

Acronym/abbreviation of the study

ARIPro

URL of the study

No Entry

Brief summary in lay language

Healthcare workers are at increased risk of exposure and illness of acute respiratory infections (ARIs). As the infections pose a risk to vulnerable patients and can lead to absenteeism from work, which in turn can limit the health system's ability to function, the implementation of effective prevention strategies is of particular importance. Co-administration of COVID-19 and influenza vaccines is widely recommended as a prevention strategy, but data on their efficacy and tolerability is limited. Data on the dynamics of respiratory infections are also scarce, particularly for RSV, for which vaccines have recently been approved. The aim of the ARIPro study is to evaluate the incidence, risk factors and the prevention by vaccination of acute respiratory infections. In addition, the impact of vaccinations and infections on quality of life and ability to work will be investigated. The focus lies on the pathogens SARS-CoV-2, influenza and RSV. The study will include a total of 600 health care workers. Data will be collected twice a year, in April and September. Participants will complete a questionnaire and submit a blood sample at each study visit. The questionnaire collects information on demographics, vaccination history and health status. The blood sample is tested for both vaccine-dependent and vaccine-independent antibodies against SARS-CoV-2, Influenza and RSV.

Brief summary in scientific language

The primary purpose of the ARIPro-study consists in gaining knowledge for the development of effective prevention strategies, especially in order to optimize the application of vaccinations against acute respiratory infections (SARS-COV-2, Influenza, RSV) in healthcare workers. Therefore, data will be collected on the immunogenicity and tolerability of the coadministration of Influenza- and SARS-CoV-2 vaccines with the hypothesis that the IgG antibody titers against SARS-CoV-2 and Influenza will be reduced by max. 50% in the subgroup which received coadministered vaccinations in comparison to the subgroup in receipt of the two vaccinations at different points in time. It is also hypothesized that the coadministration of COVID-19 and Influenza vaccinations does not lead to a significant increase in vaccine related side effects. Another study endpoint is the detection of the rates of seroconversion against COVID-19, Influenza and RSV in healthcare workers. Here it is hypothesized that the rates in the winter semesters differ between the years and the pathogens and is usually more than 10%. Influencial factors on the seroconversion rates will be evaluated. An additional goal is the assessment of the impact that infections and vaccinations (COVID-19, Influenza, RSV(only infections)) have on the quality of life and the missed days at work with the hypothesis that health care workers showing a seroconversion have more missed days at work than those not not showing seroconversion. An additional hypothesis is that the seasonal COVID-19 and Influenza vaccines lower the number of days on sick leave. The last study goal consists in the detection of influencial factors on the vaccination preferences in healthcare workers (sociodemographic factors, personal risk assessment).

Health condition or problem studied

Free text:
acute respiratory infections (Covid, Influenza, RSV) in health care workers
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
Non-interventional study: Study period: 01. 04. 2024 – 31. 03. 2027 The study cohort will consist of 600 health care workers. These are divided into 5 different subgroups: I: no seasonal vaccination II: seasonal COVID-19 vaccination only III: seasonal influenza vaccination only IV: coadministrated influenza and COVID-19 vaccination V: separated COVID-19 and influenza vaccination For each of these subgroups there will be a study date twice a year, once in April and once in September. This results in the five study periods T1- T5. These are complemented by a retrospective study date T-1, which took place in September 2023 as part of the predecessor study CoVacSer. This allows data on infection rates in the winter season 2023/2024 to be collected. The study participants complete an online questionnaire at each time of the study and either submit a blood sample (serum monovette) independentlyor, if desired, receive a blood sample from the study team. The questionnaire includes demographic questions, questions about occupation, general personal influencing factors, vaccination events and absence from work after acute respiratory illness. They also include the standardized and validated WHOQOL-BREF (World Health Organization Quality of Life) for self-assessment of health-related quality of life and WAI (Work Ability Index) for self-assessment of work ability. The following antibody titers are quantified in the blood samples by ELISA: Anti-SARS-CoV-2-Spike IgG, Anti-Influenza A-Whole Virus IgG, Anti-Influenza A-Nucleus/Matrix Protein IgG, Anti-RSV IgG or by electrochemiluminescence assay for the anti-SARS-CoV-2-nucleocapside IgG titer.

Endpoints

Primary outcome:
Goals of the study: -Evaluation of the immunogenicity and the tolerability of the coadministration of COVID-19- and Influenza vaccine -Detection of the rate of seroconversions against SARS-CoV-2, Influenza and RSV in health care workers and the influencing factors -Evaluation of the impact of SARS-CoV-2, Influenza and RSV infections and vaccinations on quality of life (assessed by WHOQOL-BREF) sick days at work and ability to work -Observation of influencial facors on vaccination preferences in health care workers
Secondary outcome:
None

Study Design

Purpose:
Screening
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
Epidemiological study

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Universitätsklinikum Würzburg Würzburg

Recruitment period and number of participants

Planned study start date:
2024-04-01
Actual study start date:
2024-04-01
Planned study completion date:
2027-03-01
Actual Study Completion Date:
No Entry
Target Sample Size:
600
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
written consent, health care workers at the time of a SARA-CoV-2 infection, a SARS-CoV-2 vaccination or at the time of recruitment

Exclusion Criteria

missing or reviked consent, COVID-19- vaccination with a vaccine that was not authorised in the european union

Addresses

Primary Sponsor

Zentrale Einrichtung Krankenhaushygiene und Antimicrobial Stewardship
PD Dr. med. Dipl.-Inf. Manuel Krone
Josef-Schneider-Straße 2/E1
97080 Würzburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Zentrale Einrichtung Krankenhaushygiene und Antimicrobial Stewardship
PD Dr. med. Manuel Krone
Josef-Schneider-Straße 2/E1
97080 Würzburg
Germany
Telephone:
+49 931 201-46710
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Zentrale Einrichtung Krankenhaushygiene und Antimicrobial Stewardship
PD Dr. med. Manuel Krone
Josef-Schneider-Straße 2/E1
97080 Würzburg
Germany
Telephone:
+49 931 201-46710
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Zentrale Einrichtung Krankenhaushygiene und Antimicrobial Stewardship
PD Dr. med. Manuel Krone
Josef-Schneider-Straße 2/E1
97080 Würzburg
Germany
Telephone:
+49 931 201-46710
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Other principal investigator

Medizinische Klinik und Poliklinik I Uniklinikum Würzburg
Dr. med. Nils Petri
Josef-Schneider-Straße 2
97080 Würzburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Interdisziplinäres Zentrum für Klinische Forschung Würzburg
97080 Würzburg
Germany
Telephone:
+49 931 201-56430
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
Josef-Schneider-Str. 4
97080 Würzburg
Germany
Telephone:
+49-931-3148315
Fax:
No Entry
Contact per E-Mail
URL:
http://www.med.uni-wuerzburg.de/ethik-kommission/startseite/

Vote of leading Ethics Committee

Date of ethics committee application:
2023-05-24
Ethics committee number:
79/21
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-07-11

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry