Zoonotic Influenza Surveillance in Belgium

Influenza, Human Clinical Trial

— ZOOIS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05827601
• Other study ID #: ZOOIS-23-24
• Status: Enrolling by invitation
• Start date: September 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Sciensano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Diagnostic Test:
• respiratory specimen
participants will perform self-sampling with a nasopharyngeal swab
• serum
participants will be invited to get a blood sample taken by a general practitioner or to perform a self sampling of capillary blood

Locations

Country	Name	City	State
Belgium	Sciensano	Brussels

Sponsors (4)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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