Clinical trial NCT01150552: Studies of Avian Influenza Transmission to Humans in Egypt
Official title: Prospective Studies of Avian Influenza Transmission to Humans in Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Avian Influenza
Keywords: Serology
Poultry
H5N1 virus
HPAI virus
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-06-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure antibodies in sera collected from poultry-exposed and non-exposed individuals
timeFrame: 4 years
measure: Draw 3 annual serum samples from each individual and record any increase in the antibody titers against AI viruses.
timeFrame: 4 years
measure: Risk or protective factors correlated with infection will be measured using the enrollment questionnaire.
timeFrame: 4 years
Secondary outcomes:
measure: Obtain nasal and naso-pharyngeal swabs from subjects reporting ILI symptoms and confirm the presence of influenza by a rapid test.
timeFrame: 4 years
measure: To send RT-PCR positive specimens collected from subjects reporting ILI symptoms to the hospital in order to isolate and characterize the virus.
timeFrame: 4 years
measure: 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.
timeFrame: 4 years
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National Research Centre
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Ghazi Kayali, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: