NCT05294003

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

February 15, 2022

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • The proportion of individuals with neutralising antibodies against WNV by region

    One blood sample collected between June and September 2021

  • The proportion of individuals with neutralising antibodies against USUV by region

    One blood sample collected between June and September 2021

Secondary Outcomes (4)

  • The proportion of individuals with IgM antibodies against WNV

    One blood sample collected between June and September 2021

  • The proportion of individuals with IgG antibodies against WNV

    One blood sample collected between June and September 2021

  • The proportion of individuals with IgM antibodies against USUV

    One blood sample collected between June and September 2021

  • The proportion of individuals with IgG antibodies against USUV

    One blood sample collected between June and September 2021

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Bird ringers from the Netherlands (about 580 licensed ringers and about 100 additional trainees or helpers)

You may qualify if:

  • Carrying-out bird ringing activities during spring, summer or early autumn 2020 in The Netherlands

You may not qualify if:

  • Not willing to participate in this study
  • Using medication interfering with antibodies production
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Centre (LUMC)

Leiden, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 33034280BACKGROUND
  • 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.

    PMID: 32326472BACKGROUND
  • 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.

    PMID: 28602915BACKGROUND
  • 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.

    PMID: 27918257BACKGROUND
  • 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.

    PMID: 32071379BACKGROUND

Related Links

Study Officials

  • Chiara de Bellegarde

    LUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 24, 2022

Study Start

May 28, 2021

Primary Completion

September 22, 2021

Study Completion

December 14, 2021

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations