Studies of Avian Influenza Transmission to Humans in Egypt

Avian Influenza Clinical Trial

Official title:

Prospective Studies of Avian Influenza Transmission to Humans in Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150552
• Other study ID #: EGYFLU XPD09-211
• Secondary ID: N01AI70005
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: July 11, 2014
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Avian Influenza
• Influenza, Human

Locations

Country	Name	City	State
Egypt	National Research Centre	Giza

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Risk or protective factors correlated with infection will be measured using the enrollment questionnaire.		4 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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