InfluenzaNCT02459171
Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers
An observational study of Influenza, run by St. Jude Children's Research Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Questionnaire, Blood sample and Nasal wash
- How many people
- 2,400 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2015to 23 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the detailed description
All residents of a household will be invited to participate. After study enrollment, participants will complete a questionnaire to collect data on the demographics and health status of the subjects and the poultry kept at the household. A 3-ml blood sample will be obtained from each subject for serological testing.
Field nurses or physicians will visit each household biweekly (October through March) or weekly (April through September) to determine if any subject has influenza-like illness (ILI), defined according to Centers for Disease Control (CDC) criteria as having measured fever of ≥38ºC. and cough and/or sore throat. Subjects with confirmed ILI (index case) will provide two nasal swabs for a point-of-care rapid influenza A test and PCR. For those who test positive for influenza A by rapid test or PCR on nasal swab (day 1), two 3-ml blood samples will be obtained. In addition, nasal washes, throat swabs, and blood samples will be obtained from all household contacts.
Cloacal swabs will also be collected from the poultry in the household on day 1.
The index case and household contacts will be re-sampled by nasal wash and throat swab on days 3, 6, 9 and 14 post initial diagnosis data, and an additional 3-ml blood sample will be obtained on day 14 for serological testing.
Household contacts who report ILI symptoms during follow-up visits to the index case will then be followed with the same follow-up regimen as the original index case.
At annual follow-up and final visits, questionnaire data will be updated if needed, and a 3-ml blood sample will be obtained from each subject for serological testing.
- Conditions
- Influenza
- Being tested
- Questionnaire, Blood sample, Nasal wash, Throat swab
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Demographic information
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.
Blood sampleOther
Also called Blood draw, Phlebotomy
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.
Nasal washOther
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.
Throat swabOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Subjects who meet eligibility requirements and consent to participate.
Interventions: Blood sample, nasal wash, throat swab, questionnaire Receives: Other: Questionnaire; Other: Blood sample; Other: Nasal wash; Other: Throat swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 years
Secondary outcomes (3)
Antigenic and genetic makeup of AI viruses infecting humans
PCR, sequencing, culture and serological techniques will be used to characterize these viruses.
Measured: Up to 6 years
Pathogenicity and disease severity of AI viruses causing human infections and the associated immune response
Data will be collected on disease pathogenicity and severity of symptoms from subjects reporting ILI and blood samples will be obtained to isolate and study peripheral blood mononuclear cells (PBMCs). PBMCs will be used to study innate and adaptive cell phenotyping by flow cytometry and functional assays that will be read out by flow cytometry and ELISPOT.
Measured: Up to 6 years
Serologic response following confirmed influenza virus infection
Antibodies will be measured in acute and convalescent sera of confirmed influenza cases.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start5 Aug 2015
- Primary completion23 Apr 2022
- Study completion23 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Human Link
- Responsible party
- Sponsor
- Investigators
- Richard Webby, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459171
- Sponsor's protocol ID
- EGYFLU2
- Other IDs
- HHSN272201400006C
- Status last verified
- May 2023
- First submitted
- 28 May 2015
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers
- ClinicalTrials.gov ID
- NCT02459171
- Acronym / sponsor ID
- EGYFLU2
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Human Link
- Study start
- 5 Aug 2015 (actual)
- Primary completion
- 23 Apr 2022 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All residents of a household will be invited to participate. After study enrollment, participants will complete a questionnaire to collect data on the demographics and health status of the subjects and the poultry kept at the household. A 3-ml blood sample will be obtained from each subject for serological testing.
Field nurses or physicians will visit each household biweekly (October through March) or weekly (April through September) to determine if any subject has influenza-like illness (ILI), defined according to Centers for Disease Control (CDC) criteria as having measured fever of ≥38ºC. and cough and/or sore throat. Subjects with confirmed ILI (index case) will provide two nasal swabs for a point-of-care rapid influenza A test and PCR. For those who test positive for influenza A by rapid test or PCR on nasal swab (day 1), two 3-ml blood samples will be obtained. In addition, nasal washes, throat swabs, and blood samples will be obtained from all household contacts.
Cloacal swabs will also be collected from the poultry in the household on day 1.
The index case and household contacts will be re-sampled by nasal wash and throat swab on days 3, 6, 9 and 14 post initial diagnosis data, and an additional 3-ml blood sample will be obtained on day 14 for serological testing.
Household contacts who report ILI symptoms during follow-up visits to the index case will then be followed with the same follow-up regimen as the original index case.
At annual follow-up and final visits, questionnaire data will be updated if needed, and a 3-ml blood sample will be obtained from each subject for serological testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Questionnaire, Other: Blood sample, Other: Nasal wash, Other: Throat swabSubjects who meet eligibility requirements and consent to participate. Interventions: Blood sample, nasal wash, throat swab, questionnaire |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: Demographic informationOnce 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. | Other | Participants |
| Blood sampleAlso: Blood draw, PhlebotomyParticipants 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. | Other | Participants |
| Nasal washNasal 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. | Other | Participants |
| Throat swabThroat 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. | Other | Participants |
Primary outcome
Incidence of avian influenza (AI) in poultry-exposed populations
Time frame: Up to 6 years
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.
Sero-prevalence rates of infection with AI viruses
Time frame: Up to 6 years
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.
Risk factors associated with AI human infections in poultry-exposed individuals
Time frame: Up to 6 years
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.
Secondary infection risk for household contacts
Time frame: Up to 6 years
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.
3 secondary outcomes
Antigenic and genetic makeup of AI viruses infecting humans
Time frame: Up to 6 years
Pathogenicity and disease severity of AI viruses causing human infections and the associated immune response
Time frame: Up to 6 years
Serologic response following confirmed influenza virus infection
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Webby, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by St. Jude Children's Research Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of avian influenza (AI) in poultry-exposed populations (time frame: Up to 6 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.