Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers

NCT02459171 | Completed

• 2 other identifiers: EGYFLU2HHSN272201400006C
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine the incidence and transmission of avian influenza viruses in humans exposed to poultry. Enrolled subjects will be selected from five different rural areas (villages) in the Nile delta region in Egypt where poultry are commonly raised. From those study sites, 2400 healthy subjects will be monitored for 6 years with annual follow up visits to measure sero-prevalence and exposure variables, and more importantly, biweekly or weekly visits to measure incidence of infection, measure secondary transmission rates, monitor symptoms, and assess immunological response. Primary Objectives:

• To estimate the incidence of avian influenza (AI) in poultry-exposed human populations.
• To estimate sero-prevalent of AI in poultry-exposed human populations.
• To investigate potential risk factors associated with AI human infections in poultry-exposed individuals.
• To investigate secondary infection risk for household contacts. Secondary Objectives:
• To characterize the antigenic and genetic makeup of AI viruses infecting humans.
• To monitor the pathogenicity and disease severity of AI viruses causing human infections and the associated immune response.
• To investigate the serologic response following confirmed influenza virus infection.

Conditions

Influenza

Outcome Measures

Primary Outcomes (4)

• Incidence of avian influenza (AI) in poultry-exposed populations

  New cases of avian influenza (AI) in poultry-exposed human populations will be detected using throat and nasal swabs and nasal washes obtained from subjects using rapid tests and molecular techniques.

  Up to 6 years

• Sero-prevalence rates of infection with AI viruses

  Prevalence rates will be measured by the presence of antibodies against AI viruses subtypes using a micro-neutralization assay. Incidence rates will be assessed based on molecular detection of AI infection annually with 95% confidence intervals. Risk or protective factors correlated with infection will be measured using the baseline enrollment questionnaire.

  Up to 6 years

• Risk factors associated with AI human infections in poultry-exposed individuals

  A questionnaire will be used to collect specific occupational, environmental, and behavioral risk factors. These will be correlated to sero-prevalence and incidence of AI infections.

  Up to 6 years

• Secondary infection risk for household contacts

  Throat and nasal swabs, blood, and nasal washes will be obtained from household contacts of poultry-exposed individuals with a confirmed influenza A infection. These will be tested for the presence of influenza A viruses or antibodies against influenza A viruses.

  Up to 6 years

Secondary Outcomes (3)

• Antigenic and genetic makeup of AI viruses infecting humans

  Up to 6 years

• Pathogenicity and disease severity of AI viruses causing human infections and the associated immune response

  Up to 6 years

• Serologic response following confirmed influenza virus infection

  Up to 6 years

Study Arms (1)

Participants

Subjects who meet eligibility requirements and consent to participate. Interventions: Blood sample, nasal wash, throat swab, questionnaire

Other: Questionnaire; Other: Blood sample; Other: Nasal wash; Other: Throat swab

Interventions

Questionnaire OTHER

Once at enrollment, subjects will complete an enrollment question to capture poultry exposure and other demographic information. Information will be updated if needed at annual follow-up and at final visits.

Also known as: Demographic information

Participants

Blood sample OTHER

Participants will have a 3-mo blood sample drawn for serological testing at enrollment, and at annual follow-up and final visits. For subjects who test positive for influenza A by rapid test or PCR (index case) on nasal swab at the biweekly or weekly visits, two 3-ml blood samples will be obtained from the index case on day 1 for serological testing for antibodies against avian influenza viruses and for isolating and studying PBMCs. Blood samples will also be obtained on day 1 from all household contacts of the index case. Additional 3-ml blood samples will be obtained on day 14 for serology and PBMCs.

Also known as: Blood draw, Phlebotomy

Participants

Nasal wash OTHER

Nasal washes will be obtained from subjects who test positive for influenza A by rapid test or PCR on nasal swab (index case). Nasal washes will also be obtained from all household contacts of the index case. The index case and household contacts will be re-sampled on days 3, 6, 9 and 14 post initial diagnosis date.

Participants

Throat swab OTHER

Throat swabs will be obtained from subjects who test positive for influenza A by rapid test or PCR on nasal swab (index case). Throat swabs will also be obtained from all household contacts of the index case. The index case and household contacts will be re-sampled on days 3, 6, 9 and 14 post initial diagnosis date.

Participants

Eligibility Criteria

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

Study Population

This study will be conducted on rural Egyptian poultry growers in areas where avian influenza is endemic in Egypt. The study sample is expected to have the same composition as the general population in that area.

You may qualify if:

• Poultry-exposed individuals with poultry in the household willing to participate by signing a consent or assent form as appropriate for age, completing the study questionnaire, and permitting the withdrawal of blood, nasal washes, nasal swabs, and throat swabs.

You may not qualify if:

• Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to exclude such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample.)
• Terminally ill individuals.
• Children who are less than 2 years old when baseline enrollment is performed.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Department of Health and Human Services: collaborator
• Human Link: collaborator

Study Sites (1)

National Research Centre

Cairo, Egypt

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Subjects who agree to participate in this study will have blood samples collected for influenza testing, antibody determination and viral typing. Subjects will be asked for permission to keep any remaining samples for possible use in future research studies such as testing for antibodies or evidence of infection with another influenza virus or other pathogen. Some samples will be stored indefinitely at the laboratory at the National Research Centre (NRC), Egypt, or St. Jude Children's Research Hospital (SJCRH).

MeSH Terms

Conditions

Influenza, Human

Interventions

Surveys and Questionnaires; Blood Specimen Collection; Phlebotomy; Nasal Lavage

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Therapeutics; Therapeutic Irrigation

Study Officials

• Richard Webby, PhD

  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: May 28, 2015
• First Posted: June 1, 2015
• Study Start: August 5, 2015
• Primary Completion: April 23, 2022
• Study Completion: April 23, 2022
• Last Updated: April 3, 2024

Record last verified: 2023-05

Locations

EG (1)