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

NCT ID: NCT02459171

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-05
• Study Completion Date: 2022-04-23

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants

Subjects who meet eligibility requirements and consent to participate.

Interventions: Blood sample, nasal wash, throat swab, questionnaire

Questionnaire

Intervention Type: OTHER

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.

Blood sample

Intervention Type: OTHER

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.

Nasal wash

Intervention Type: OTHER

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.

Throat swab

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Demographic information; Blood draw; Phlebotomy

Eligibility Criteria

Inclusion Criteria

• Poultry-exposed individuals with poultry in the household willing to participate by signing a consent or assent form as appropriate for age, completing the study questionnaire, and permitting the withdrawal of blood, nasal washes, nasal swabs, and throat swabs.

Exclusion Criteria

• Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to exclude such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample.)
• Terminally ill individuals.
• Children who are less than 2 years old when baseline enrollment is performed.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Human Link

UNKNOWN

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Webby, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

National Research Centre

Cairo, , Egypt

Countries

Egypt

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

HHSN272201400006C

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EGYFLU2

Identifier Type: -

Identifier Source: org_study_id