Studies of Avian Influenza Transmission to Humans in Egypt

Prospective 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

Study Overview

• Status: Completed
• Conditions: Avian Influenza

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12311
    • National Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Exposed subjects will be enrolled at the rural areas of Egypt where poultry production is located. Controls will be enrolled in urban Cairo. Households will be selected from neighborhoods without live bird markets close to the location of the NRC. All members of a household will be enrolled. Cohort of exposed subjects will be assembled from villages from 3 governorates in this area as well as 2 governorates south of Cairo where human cases of AI were reported. Hence, 5 villages will make up 5 field sites. From each village, the team will enroll 150 individuals with exposure to poultry. The control group, i.e., individuals not occupationally exposed to poultry, will be enrolled from urban Cairo, the capital of Egypt.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure antibodies in sera collected from poultry-exposed and non-exposed individuals	Prevalence rates will be measured by the presence of antibodies against AI viruses of types H4-H12 using a microneutralization assay.	4 years
Draw 3 annual serum samples from each individual and record any increase in the antibody titers against AI viruses.	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.	4 years
Risk or protective factors correlated with infection will be measured using the enrollment questionnaire.		4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obtain nasal and naso-pharyngeal swabs from subjects reporting ILI symptoms and confirm the presence of influenza by a rapid test.	Obtain swabs from the household contacts of individuals with a confirmed influenza A infection and test them for the presence of influenza A viruses	4 years
To send RT-PCR positive specimens collected from subjects reporting ILI symptoms to the hospital in order to isolate and characterize the virus.		4 years
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.		4 years

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Ghazi Kayali, Ph.D, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Serology; Poultry; H5N1 virus; HPAI virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Influenza in Birds
• Other Study ID Numbers: EGYFLU XPD09-211; N01-AI-70005 (Other Identifier: NIAID Centers of Excellence for Influenza Research and Surveillance)