Household Transmission of Zoonotic Influenza Viruses in a Cohort of Egyptian Poultry Growers
NCT02459171 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2400
Last updated 2024-04-03
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
Interventions
- OTHER
-
Questionnaire
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.
- OTHER
-
Blood sample
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.
- OTHER
-
Nasal wash
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.
- OTHER
-
Throat swab
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.
Sponsors & Collaborators
-
Department of Health and Human Services
collaborator FED -
Human Link
collaborator UNKNOWN -
St. Jude Children's Research Hospital
lead OTHER
Principal Investigators
-
Richard Webby, PhD · St. Jude Children's Research Hospital
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-08-05
- Primary Completion
- 2022-04-23
- Completion
- 2022-04-23
Countries
- Egypt
Study Locations
More Related Trials
-
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)
NCT00289510 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
NCT01006798 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
NCT00425893 ·Status: COMPLETED ·Phase: NA
-
A Pilot Study for Collection of Anti-Influenza A Immune Plasma
NCT00984451 ·Status: COMPLETED
-
Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers
NCT02594189 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of Live Influenza A Vaccine for Avian Influenza H7N7
NCT00922259 ·Status: COMPLETED ·Phase: PHASE1
-
Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.
NCT02067117 ·Status: COMPLETED ·Phase: PHASE4
-
Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine
NCT00311727 ·Status: COMPLETED ·Phase: NA
-
Safety Study of Avian Flu Vaccine
NCT00408109 ·Status: COMPLETED ·Phase: PHASE1
-
Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults
NCT00516035 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age
NCT00970177 ·Status: COMPLETED ·Phase: PHASE3
-
H5N1 Mix and Match With MF59
NCT01317745 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
NCT00347672 ·Status: COMPLETED ·Phase: PHASE1
-
Case-control Study of Pandemic A/H1N1 Influenza Risk Factors In Lebanon
NCT01298206 ·Status: COMPLETED
-
Effect of Influenza Vaccination on Donor Egg Recipient Outcomes
NCT02946177 ·Status: UNKNOWN ·Phase: PHASE4
-
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age
NCT00971906 ·Status: COMPLETED ·Phase: PHASE3
-
Influenza Antiviral DAS-181-F04 in Healthy Adults
NCT01651494 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations
NCT01746082 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults
NCT00546585 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults
NCT00853255 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Safety and Immunogenicity of a Live Attenuated Virus Vaccine for the Prevention of H2N3 Influenza
NCT01175122 ·Status: COMPLETED ·Phase: PHASE1
-
H5N1 Priming and Boosting Strategies
NCT00703053 ·Status: COMPLETED ·Phase: PHASE2
-
Household Influenza Transmission Study
NCT01251679 ·Status: COMPLETED ·Phase: NA
-
Inactivated Influenza A/H5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses
NCT00417560 ·Status: WITHDRAWN ·Phase: NA
-
Transmission of Influenza Virus From Asymptomatic Healthcare Workers and Inpatients in the Acute Care Hospital Setting
NCT02478905 ·Status: COMPLETED