Zoonotic Influenza Surveillance in Belgium

NCT05827601 | Unknown

• 1 other identifier: ZOOIS-23-24
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (2)

• Number of sentinel participants positive for a non-seasonal influenza virus

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

  every 2 weeks through study completion (December 2024)

• Number of outbreak participants positive for a non-seasonal influenza virus

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

  every 2 days during 2 weeks after enrollment

Secondary Outcomes (1)

• Number of outbreak participants with seroconversion against a non-seasonal influenza virus

  at enrollment and about 4 weeks after

Study Arms (4)

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; Diagnostic Test: serum

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

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

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

Interventions

respiratory specimen DIAGNOSTIC_TEST

participants will perform self-sampling with a nasopharyngeal swab

Avian Influenza Outbreak Farms; Pig Industry Veterinarian Sentinel Network; Poultry Farm Sentinel Network; Wild bird/life Rehabilitation Centre Sentinel Network

serum DIAGNOSTIC_TEST

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

Avian Influenza Outbreak Farms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Workers or volunteers of one of the targeted groups within the sites that accept to take part in the study

You may qualify if:

• 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

You may not qualify if:

• \- people who had a broken nose might have difficulties to perform self-swabbing

Sponsors & Collaborators

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

Study Sites (1)

Sciensano

Brussels, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

respiratory specimens will be registered and stored in the Biobank for 10 years after the end of the study, and could be tested for other pathogens but they will not be used for human genetic or biomarker analyses.

MeSH Terms

Conditions

Influenza, Human

Interventions

Respiratory Rate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Belgian National Influenza Centre

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 25, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

BE (1)