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Completed

NCT Number: NCT01150552

Studies of Avian Influenza Transmission to Humans in Egypt

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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Key information

Conditions

Avian Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Orthomyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Research Centre

Giza, 12311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measure antibodies in sera collected from poultry-exposed and non-exposed individuals

    Time frame: 4 years

    Prevalence rates will be measured by the presence of antibodies against AI viruses of types H4-H12 using a microneutralization assay.

  2. Draw 3 annual serum samples from each individual and record any increase in the antibody titers against AI viruses.

    Time frame: 4 years

    Incidence rates will be assessed based on a 2-fold increase of antibody titers between baseline and follow-up and between follow-up and the final visit.

  3. Risk or protective factors correlated with infection will be measured using the enrollment questionnaire.

    Time frame: 4 years

Secondary outcomes

  1. Obtain nasal and naso-pharyngeal swabs from subjects reporting ILI symptoms and confirm the presence of influenza by a rapid test.

    Time frame: 4 years

    Obtain swabs from the household contacts of individuals with a confirmed influenza A infection and test them for the presence of influenza A viruses

  2. To send RT-PCR positive specimens collected from subjects reporting ILI symptoms to the hospital in order to isolate and characterize the virus.

    Time frame: 4 years

  3. Collect data on disease pathogenicity and severity of symptoms from subjects reporting ILI and obtain a blood sample to isolate and study peripheral blood mononuclear cells.

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Prospective Studies of Avian Influenza Transmission to Humans in Egypt

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2010
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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