Studies of Avian Influenza Transmission to Humans in Egypt

St. Jude Children's Research Hospital

Status: Completed

Conditions: Avian Influenza

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01150552

EGYFLU XPD09-211

N01-AI-70005 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,000 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Poultry exposed individuals

Description:

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.

Non-poultry exposed adult controls

Description:

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.