Studies of Avian Influenza Transmission to Humans in Egypt

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-05-31

Brief Summary

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The main focus of the study is:

* To estimate seroprevalence of AI in poultry-exposed and non-exposed human populations.
* To estimate the incidence of AI in poultry-exposed and non-exposed human populations.
* To investigate risk factors associated with AI infections in occupationally-exposed poultry workers.

The secondary objectives of the study:

* To investigate patterns in transmission of AI to household contacts of AI clinical cases
* To isolate AI viruses from acute cases
* To monitor the pathogenicity and disease severity of AI viruses causing human infections

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Detailed Description

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This 4-year prospective cohort study to compare individuals with occupational exposure to poultry with non-poultry exposed adult controls for evidence of incident and previous infections with AI viruses. At the start of this study, study staff will obtain informed consent, and a blood sample will be obtained from study volunteers to establish baseline levels of antibodies against avian influenza types H4-H12. Subjects will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. After one year, study subjects will be interviewed again to note any changes in exposure variables. At this time, another blood sample will be obtained and tested for any changes in antibodies' levels. The same procedures will be repeated at the final visit after another year. Exposed individuals will be selected from rural areas where poultry is commonly raised. Non-exposed controls will be selected from urban neighborhoods in Cairo.

Conditions

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Avian Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Poultry exposed individuals

Any individual who had an occupational contact with poultry in the previous five years will be considered exposed. Individuals working on poultry farms, poultry wet markets, or keeping limited numbers of poultry in their backyard, are considered exposed.

No interventions assigned to this group

Non-poultry exposed adult controls

Unexposed individuals must have no occupational exposure to poultry in their lifetime and must also not be exposed to poultry purchased from live bird markets.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Be willing to participate by signing a consent/assent form, completing the study questionnaire, and permitting the withdrawal of blood.
* Does not buy poultry from live bird markets (for controls only).

Exclusion Criteria

* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy.
* Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago.
* 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