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

NCT02459171 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2400

Last updated 2024-04-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Richard Webby, PhD · St. Jude Children's Research Hospital

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-05
Primary Completion
2022-04-23
Completion
2022-04-23

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459171 on ClinicalTrials.gov