Zoonotic Influenza Surveillance in Belgium (ZOOIS)

Active Surveillance of Influenza Virus Zoonotic Transmission Events: a Pilot Study in Belgium

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Influenza, Human
• Intervention / Treatment: Diagnostic test: respiratory specimen; Diagnostic test: serum

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Sciensano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of outbreak participants with seroconversion against a non-seasonal influenza virus	result of inhibition of haemagglutination or seroneutralisation assay	at enrollment and about 4 weeks after

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: ZOOIS-23-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No