Studies of Avian Influenza Transmission to Humans in Egypt

NCT01150552 | Completed

• 2 other identifiers: EGYFLU XPD09-211N01AI70005
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Avian Influenza

Keywords

Serology; Poultry; H5N1 virus; HPAI virus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

National Research Centre

Giza, 12311, Egypt

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Sera will be tested for human antibodies against AI viruses (types H4-H12) using a microneutralization assay. Study sera will be examined for antibodies against human influenza types H1 and H3 using a hemagglutination inhibition procedure.

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases

Study Officials

• Ghazi Kayali, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 25, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 14, 2014

Record last verified: 2014-07

Locations

EG (1)