NCT02459171

Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,400 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

This study seeks to determine the incidence and transmission of avian influenza viruses in humans exposed to poultry. Enrolled subjects will be selected from five different rural areas (villages) in the Nile delta region in Egypt where poultry are commonly raised. From those study sites, 2400 healthy subjects will be monitored for 6 years with annual follow up visits to measure sero-prevalence and exposure variables, and more importantly, biweekly or weekly visits to measure incidence of infection, measure secondary transmission rates, monitor symptoms, and assess immunological response. Primary Objectives: * To estimate the incidence of avian influenza (AI) in poultry-exposed human populations. * To estimate sero-prevalent of AI in poultry-exposed human populations. * To investigate potential risk factors associated with AI human infections in poultry-exposed individuals. * To investigate secondary infection risk for household contacts. Secondary Objectives: * To characterize the antigenic and genetic makeup of AI viruses infecting humans. * To monitor the pathogenicity and disease severity of AI viruses causing human infections and the associated immune response. * To investigate the serologic response following confirmed influenza virus infection.

Detailed description

All residents of a household will be invited to participate. After study enrollment, participants will complete a questionnaire to collect data on the demographics and health status of the subjects and the poultry kept at the household. A 3-ml blood sample will be obtained from each subject for serological testing. Field nurses or physicians will visit each household biweekly (October through March) or weekly (April through September) to determine if any subject has influenza-like illness (ILI), defined according to Centers for Disease Control (CDC) criteria as having measured fever of ≥38ºC. and cough and/or sore throat. Subjects with confirmed ILI (index case) will provide two nasal swabs for a point-of-care rapid influenza A test and PCR. For those who test positive for influenza A by rapid test or PCR on nasal swab (day 1), two 3-ml blood samples will be obtained. In addition, nasal washes, throat swabs, and blood samples will be obtained from all household contacts. Cloacal swabs will also be collected from the poultry in the household on day 1. The index case and household contacts will be re-sampled by nasal wash and throat swab on days 3, 6, 9 and 14 post initial diagnosis data, and an additional 3-ml blood sample will be obtained on day 14 for serological testing. Household contacts who report ILI symptoms during follow-up visits to the index case will then be followed with the same follow-up regimen as the original index case. At annual follow-up and final visits, questionnaire data will be updated if needed, and a 3-ml blood sample will be obtained from each subject for serological testing.

Conditions

• Influenza

Interventions

Type	Name	Description
OTHER	Questionnaire	Once at enrollment, subjects will complete an enrollment question to capture poultry exposure and other demographic information. Information will be updated if needed at annual follow-up and at final visits.
OTHER	Blood sample	Participants will have a 3-mo blood sample drawn for serological testing at enrollment, and at annual follow-up and final visits. For subjects who test positive for influenza A by rapid test or PCR (index case) on nasal swab at the biweekly or weekly visits, two 3-ml blood samples will be obtained from the index case on day 1 for serological testing for antibodies against avian influenza viruses and for isolating and studying PBMCs. Blood samples will also be obtained on day 1 from all household contacts of the index case. Additional 3-ml blood samples will be obtained on day 14 for serology and PBMCs.
OTHER	Nasal wash	Nasal washes will be obtained from subjects who test positive for influenza A by rapid test or PCR on nasal swab (index case). Nasal washes will also be obtained from all household contacts of the index case. The index case and household contacts will be re-sampled on days 3, 6, 9 and 14 post initial diagnosis date.
OTHER	Throat swab	Throat swabs will be obtained from subjects who test positive for influenza A by rapid test or PCR on nasal swab (index case). Throat swabs will also be obtained from all household contacts of the index case. The index case and household contacts will be re-sampled on days 3, 6, 9 and 14 post initial diagnosis date.

Timeline

• Start date: 2015-08-05
• Primary completion: 2022-04-23
• Completion: 2022-04-23
• First posted: 2015-06-01
• Last updated: 2024-04-03

Locations

1 site across 1 country: Egypt