- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05294003
West Nile Virus Seroprevalence Under Bird Ringers
March 14, 2022 updated by: Chiara de Bellegarde, Leiden University Medical Center
Prevalence of West Nile Virus and Usutu Virus Serum Antibodies in Dutch Bird Ringers
In August 2020, West Nile Virus (WNV) was isolated from a live common whitethroat for the first time in The Netherlands.
Follow-up sampling showed that the virus could also be detected in mosquitos from the same location during at least a whole month of sampling.
On 15 October 2020, one case of West Nile virus infection has been reported in a man who was likely infected in the Utrecht region.
This is the first time that a locally acquired human case of WNV infection has been reported in The Netherlands.
Six additional cases have been identified, one of which from the region Arnhem.
West Nile virus infection is a mosquito-borne zoonosis.
The disease, which has spread across the Northern Hemisphere in the past three decades, is now found on an annual basis in many European countries where the centre of gravity lies in Southern-European countries.
Recently, WNV was reported for the first time in Germany.
The virus is transmitted among birds through the bite of infected mosquitoes and incidentally infects humans and other mammals, such as horses.
Around 80% of human WNV infections are asymptomatic.
The most common clinical presentation is West Nile fever but, older people and immunocompromised persons are at higher risk of developing neuro-invasive disorders (West Nile neuroinvasive disease).
Currently, there are no prophylaxis or specific treatment against the disease in humans.
In addition, Usutu virus (USUV) was detected in The Netherlands in 2016.
USUV is another flavivirus, related to WNV, and also capable of infecting humans.
Disease associated with USUV infection in humans appears to be milder and only limited number of cases have been identified.
During their bird catching activities, bird ringers are intensively exposed to mosquito bites at the natural habitat of the birds and at the same time of the day when mosquitoes are particularly active.
The aim of this study is therefore to determine the prevalence of WNV and USUV serum antibodies in bird ringers in The Netherlands.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
162
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leiden, Netherlands
- Leiden University Medical Centre (LUMC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Bird ringers from the Netherlands (about 580 licensed ringers and about 100 additional trainees or helpers)
Description
Inclusion Criteria:
- Carrying-out bird ringing activities during spring, summer or early autumn 2020 in The Netherlands
Exclusion Criteria:
- Not willing to participate in this study
- Using medication interfering with antibodies production
- Under 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The proportion of individuals with neutralising antibodies against WNV by region
Time Frame: One blood sample collected between June and September 2021
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One blood sample collected between June and September 2021
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The proportion of individuals with neutralising antibodies against USUV by region
Time Frame: One blood sample collected between June and September 2021
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One blood sample collected between June and September 2021
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of individuals with IgM antibodies against WNV
Time Frame: One blood sample collected between June and September 2021
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One blood sample collected between June and September 2021
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The proportion of individuals with IgG antibodies against WNV
Time Frame: One blood sample collected between June and September 2021
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One blood sample collected between June and September 2021
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The proportion of individuals with IgM antibodies against USUV
Time Frame: One blood sample collected between June and September 2021
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One blood sample collected between June and September 2021
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The proportion of individuals with IgG antibodies against USUV
Time Frame: One blood sample collected between June and September 2021
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One blood sample collected between June and September 2021
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chiara de Bellegarde, LUMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sikkema RS, Schrama M, van den Berg T, Morren J, Munger E, Krol L, van der Beek JG, Blom R, Chestakova I, van der Linden A, Boter M, van Mastrigt T, Molenkamp R, Koenraadt CJ, van den Brand JM, Oude Munnink BB, Koopmans MP, van der Jeugd H. Detection of West Nile virus in a common whitethroat (Curruca communis) and Culex mosquitoes in the Netherlands, 2020. Euro Surveill. 2020 Oct;25(40):2001704. doi: 10.2807/1560-7917.ES.2020.25.40.2001704. Erratum In: Euro Surveill. 2020 Oct;25(43):
- Ziegler U, Santos PD, Groschup MH, Hattendorf C, Eiden M, Hoper D, Eisermann P, Keller M, Michel F, Klopfleisch R, Muller K, Werner D, Kampen H, Beer M, Frank C, Lachmann R, Tews BA, Wylezich C, Rinder M, Lachmann L, Grunewald T, Szentiks CA, Sieg M, Schmidt-Chanasit J, Cadar D, Luhken R. West Nile Virus Epidemic in Germany Triggered by Epizootic Emergence, 2019. Viruses. 2020 Apr 15;12(4):448. doi: 10.3390/v12040448.
- Gaibani P, Rossini G. An overview of Usutu virus. Microbes Infect. 2017 Jul-Aug;19(7-8):382-387. doi: 10.1016/j.micinf.2017.05.003. Epub 2017 Jun 8.
- Rijks JM, Kik ML, Slaterus R, Foppen R, Stroo A, IJzer J, Stahl J, Grone A, Koopmans M, van der Jeugd HP, Reusken C. Widespread Usutu virus outbreak in birds in the Netherlands, 2016. Euro Surveill. 2016 Nov 10;21(45):30391. doi: 10.2807/1560-7917.ES.2016.21.45.30391.
- Oude Munnink BB, Munger E, Nieuwenhuijse DF, Kohl R, van der Linden A, Schapendonk CME, van der Jeugd H, Kik M, Rijks JM, Reusken CBEM, Koopmans M. Genomic monitoring to understand the emergence and spread of Usutu virus in the Netherlands, 2016-2018. Sci Rep. 2020 Feb 18;10(1):2798. doi: 10.1038/s41598-020-59692-y.
Helpful Links
- Rijksinstituut voor Volksgezondheid en Milieu, Ministerie van Volksgezondheid, Welzijn en Sport. Eerste patiënt in Nederland met westnijlvirus
- European Center for Disease Prevention and Control. Factsheet about West Nile fever [Internet]. Stockholm: ECDC; 2020
- Rijksinstituut voor Volksgezondheid en Milieu, Ministerie van Volksgezondheid, Welzijn en Sport. Westnijlkoorts
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2021
Primary Completion (Actual)
September 22, 2021
Study Completion (Actual)
December 14, 2021
Study Registration Dates
First Submitted
February 15, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (Actual)
March 24, 2022
Study Record Updates
Last Update Posted (Actual)
March 24, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P20.112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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