Clinical trial NCT05827601: Zoonotic Influenza Surveillance in Belgium
Official title: Active Surveillance of Influenza Virus Zoonotic Transmission Events: a Pilot Study in Belgium
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Influenza, Human
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: Sciensano
name: Belgian Federal Public Service, Food Chain Safety and Environment
name: Agentschap Zorg en Gezondheid
First posted: 2023-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of sentinel participants positive for a non-seasonal influenza virus
timeFrame: every 2 weeks through study completion (December 2024)
measure: Number of outbreak participants positive for a non-seasonal influenza virus
timeFrame: every 2 days during 2 weeks after enrollment
Secondary outcomes:
measure: Number of outbreak participants with seroconversion against a non-seasonal influenza virus
timeFrame: at enrollment and about 4 weeks after
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sciensano
Study officials:
References: