Avian InfluenzaNCT01150552
Studies of Avian Influenza Transmission to Humans in Egypt
An observational study of Avian Influenza, run by St. Jude Children's Research Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Avian Influenza
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2010to May 2014
- 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: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Studies of Avian Influenza Transmission to Humans in Egypt
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
Read the 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.
- Conditions
- Avian Influenza
- Keywords
- Serology, Poultry, H5N1 virus, HPAI virus
- Medical subject headings
- Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 years
Risk or protective factors correlated with infection will be measured using the enrollment questionnaire.
Measured: 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.
Obtain swabs from the household contacts of individuals with a confirmed influenza A infection and test them for the presence of influenza A viruses
Measured: 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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avian 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghazi Kayali, Ph.D, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150552
- Sponsor's protocol ID
- EGYFLU XPD09-211
- Other IDs
- N01AI70005
- Status last verified
- Jul 2014
- First submitted
- 22 Jun 2010
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Studies of Avian Influenza Transmission to Humans in Egypt
- ClinicalTrials.gov ID
- NCT01150552
- Acronym / sponsor ID
- EGYFLU XPD09-211
- Conditions
- Avian Influenza
- Keywords
- Serology, Poultry, H5N1 virus, HPAI virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 Jun 2010 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure antibodies in sera collected from poultry-exposed and non-exposed individuals
Time frame: 4 years
Prevalence rates will be measured by the presence of antibodies against AI viruses of types H4-H12 using a microneutralization assay.
Draw 3 annual serum samples from each individual and record any increase in the antibody titers against AI viruses.
Time frame: 4 years
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.
Risk or protective factors correlated with infection will be measured using the enrollment questionnaire.
Time frame: 4 years
3 secondary outcomes
Obtain nasal and naso-pharyngeal swabs from subjects reporting ILI symptoms and confirm the presence of influenza by a rapid test.
Time frame: 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.
Time frame: 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.
Time frame: 4 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 14 Jul 2014.
- 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.
Ghazi Kayali, Ph.D 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 Avian 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 2 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 14 Jul 2014. 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?
Measure antibodies in sera collected from poultry-exposed and non-exposed individuals (time frame: 4 years). The study lists 3 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 14 Jul 2014.