ZOOIS: Zoonotic Influenza Surveillance in Belgium

Sponsor
Cyril Barbezange (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05827601
Collaborator
Sciensano (Other), Belgian Federal Public Service, Food Chain Safety and Environment (Other), Agentschap Zorg en Gezondheid (Other)
200
19

Study Details

Study Description

Brief Summary

The project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people.

Currently, highly pathogenic clade2.3.4.4b H5 avian influenza viruses are continuously circulating in wild birds in Belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. Several reports of suspected human infection have been made by different countries. In addition, the virus was detected in sick non-human mammals. The large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). This increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans.

Likewise, there have also been an increased number of human cases of swine influenza reported by several European countries. A pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic.

As a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: respiratory specimen
  • Diagnostic Test: serum

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Active Surveillance of Influenza Virus Zoonotic Transmission Events: a Pilot Study in Belgium
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Avian Influenza Outbreak Farms

People involved in outbreak management, ranging from poultry farm owners and their family to inspectors through veterinarians and cullers/cleaners, will be invited to take part in the study at the earliest step possible after outbreak detection. Self sampling by nasopharyngeal swab will be requested every 2 days during 2 weeks.

Diagnostic Test: respiratory specimen
participants will perform self-sampling with a nasopharyngeal swab

Diagnostic Test: serum
participants will be invited to get a blood sample taken by a general practitioner or to perform a self sampling of capillary blood

Poultry Farm Sentinel Network

People working in poultry farms and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study. anticipated: 15

Diagnostic Test: respiratory specimen
participants will perform self-sampling with a nasopharyngeal swab

Wild bird/life Rehabilitation Centre Sentinel Network

People working in wild bird/life rehabilitation centers and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study. anticipated: 25

Diagnostic Test: respiratory specimen
participants will perform self-sampling with a nasopharyngeal swab

Pig Industry Veterinarian Sentinel Network

Veterinarians working in the pig industry and in contact with animals will be invited to join the cohort. Self sampling by nasopharyngeal swab will be requested every 2 weeks for the whole duration of the study. anticipated: 15

Diagnostic Test: respiratory specimen
participants will perform self-sampling with a nasopharyngeal swab

Outcome Measures

Primary Outcome Measures

  1. Number of sentinel participants positive for a non-seasonal influenza virus [every 2 weeks through study completion (December 2024)]

    result of RT-qPCR test to detect and characterize non-influenza viruses

  2. Number of outbreak participants positive for a non-seasonal influenza virus [every 2 days during 2 weeks after enrollment]

    result of RT-qPCR test to detect and characterize non-influenza viruses

Secondary Outcome Measures

  1. Number of outbreak participants with seroconversion against a non-seasonal influenza virus [at enrollment and about 4 weeks after]

    result of inhibition of haemagglutination or seroneutralisation assay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • worker or volunteer of one of the targeted groups at one of the selected sites and accepting to take part in the study

  • to have regular contacts with animals within job/activity framework

  • being committed to take the regular samples

Exclusion Criteria:
  • people who had a broken nose might have difficulties to perform self-swabbing

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cyril Barbezange
  • Sciensano
  • Belgian Federal Public Service, Food Chain Safety and Environment
  • Agentschap Zorg en Gezondheid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cyril Barbezange, Head of Belgian National Influenza Centre, Sciensano
ClinicalTrials.gov Identifier:
NCT05827601
Other Study ID Numbers:
  • ZOOIS-23-24
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2023