West Nile VirusNCT05294003
West Nile Virus Seroprevalence Under Bird Ringers
An observational study of West Nile Virus, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- West Nile Virus
- How many people
- 162 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 May 2021to 14 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bird ringers from the Netherlands (about 580 licensed ringers and about 100 additional trainees or helpers)
Who may be able to join
- Carrying-out bird ringing activities during spring, summer or early autumn 2020 in The Netherlands
Who cannot join
- Not willing to participate in this study
- Using medication interfering with antibodies production
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- West Nile Virus
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of individuals with neutralising antibodies against WNV by region
Measured: One blood sample collected between June and September 2021
The proportion of individuals with neutralising antibodies against USUV by region
Measured: One blood sample collected between June and September 2021
Secondary outcomes (4)
The proportion of individuals with IgM antibodies against WNV
Measured: One blood sample collected between June and September 2021
The proportion of individuals with IgG antibodies against WNV
Measured: One blood sample collected between June and September 2021
The proportion of individuals with IgM antibodies against USUV
Measured: One blood sample collected between June and September 2021
The proportion of individuals with IgG antibodies against USUV
Measured: One blood sample collected between June and September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start28 May 2021
- Primary completion22 Sep 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for West Nile VirusStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, Leiden University, Netherlands Institute of Ecology
- Responsible party
- Principal investigator, Chiara de Bellegarde, Leiden University Medical Center
- Investigators
- Chiara de Bellegarde, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294003
- Sponsor's protocol ID
- P20.112
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33034280Ziegler 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.
PubMed 32326472Gaibani 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.
PubMed 28602915Rijks 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.
PubMed 27918257Oude 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.
PubMed 32071379
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of West Nile Virus and Usutu Virus Serum Antibodies in Dutch Bird Ringers
- ClinicalTrials.gov ID
- NCT05294003
- Acronym / sponsor ID
- P20.112
- Conditions
- West Nile Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, UMC Utrecht, Leiden University, Netherlands Institute of Ecology
- Study start
- 28 May 2021 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bird ringers from the Netherlands (about 580 licensed ringers and about 100 additional trainees or helpers)
Key inclusion criteria (1 listed)
- Carrying-out bird ringing activities during spring, summer or early autumn 2020 in The Netherlands
Key exclusion criteria (3 listed)
- Not willing to participate in this study
- Using medication interfering with antibodies production
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of individuals with neutralising antibodies against WNV by region
Time frame: One blood sample collected between June and September 2021
The proportion of individuals with neutralising antibodies against USUV by region
Time frame: One blood sample collected between June and September 2021
4 secondary outcomes
The proportion of individuals with IgM antibodies against WNV
Time frame: One blood sample collected between June and September 2021
The proportion of individuals with IgG antibodies against WNV
Time frame: One blood sample collected between June and September 2021
The proportion of individuals with IgM antibodies against USUV
Time frame: One blood sample collected between June and September 2021
The proportion of individuals with IgG antibodies against USUV
Time frame: One blood sample collected between June and September 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 33034280Sikkema 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.
- Background: PubMed 32326472Ziegler 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.
- Background: PubMed 28602915Gaibani 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.
- Background: PubMed 27918257Rijks 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.
- Background: PubMed 32071379Oude 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.
- Rijksinstituut voor Volksgezondheid en Milieu, Ministerie van Volksgezondheid, Welzijn en Sport. Eerste patiënt in Nederland met westnijlvirusLink provided by the sponsor.
- European Center for Disease Prevention and Control. Factsheet about West Nile fever \[Internet\]. Stockholm: ECDC; 2020Link provided by the sponsor.
- Rijksinstituut voor Volksgezondheid en Milieu, Ministerie van Volksgezondheid, Welzijn en Sport. WestnijlkoortsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara de Bellegarde principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of West Nile Virus, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of individuals with neutralising antibodies against WNV by region (time frame: One blood sample collected between June and September 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294003, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.