Avian Influenza Studies In Lebanon

NCT01107262 | Completed

• 1 other identifier: AVIFLU -XPD09-010
• Study Type: observational
• Target: 250
• Locations: 2 countries
• Sites: 2

Brief Summary

The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005 and has since established itself in local domestic birds and is now considered endemic in several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies also provide some evidence suggesting that humans exposed to these sick birds are showing elevated antibody titers against these LPAI H9 viruses. This study will focus on the following objectives:

• To determine the seroprevalence of AI in poultry-exposed and non-exposed human populations.
• To identify risk factors associated with AI infections in occupationally-exposed poultry workers.
• To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.

Conditions

Avian Influenza; Virus Diseases

Keywords

H5N1 Subtype; Avian viruses; Highly pathogenic avian influenza (HPAI)

Outcome Measures

Primary Outcomes (3)

• The seroprevalence of Avian Influenza in poultry-exposed and non-exposed human populations.

  1 year

• Risk factors associated with AI infections in occupationally-exposed poultry workers.

  1 year

• Nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.

  1 year

Study Arms (2)

Poultry exposed adults

This seroepidemiological study proposes to compare adults with occupational exposure to poultry with non-poultry exposed adult controls for evidence of previous infections with AI viruses.In this study, any person with occupational exposure to poultry i.e. works in poultry production facility or raises a smaller number of poultry on his/her farm will be considered exposed. The questionnaire used in this study will capture poultry exposure data through a group of variables assessing type of occupational setting, length of time of exposure, flock size, type of work performed, and personal protective equipment (PPE) used.

Poultry Non-exposed Adult Controls

Controls, adults who were never exposed to poultry, will be enrolled from urban areas such as the capital Beirut. Controls will be invited to volunteer by word of mouth at public/community sites.

Eligibility Criteria

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

Study Population

This study will be conducted in the rural areas of Lebanon where poultry production is located.Specifically, three main regions will be included in this study, the Beqaa, North Lebanon, and South Lebanon regions.The Mount Lebanon and Beirut regions are heavily urbanized and poultry production in these regions is minimal.Poultry-exposed individuals will be enrolled according to the following scheme:100 from Beqaa, 50 from North Lebanon, and 50 from South Lebanon. The 50 non-exposed individuals will be enrolled from Beirut. Villages will be randomly selected from each of the 3 regions where enrollment will occur.Each village will be assigned a number and then a random digit sheet will be generated and used to randomly select villages. Controls, adults who were never exposed to poultry, will be enrolled from urban areas such as the capital Beirut. Controls will be invited to volunteer by word of mouth at public/community sites.

You may qualify if:

• Be at least 18 years old.
• Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample.

You may not qualify if:

• Less than 18 years old.
• 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).
• Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• American University of Beirut Medical Center: collaborator

Study Sites (2)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

American University of Beirut

Beirut, Beyrouth, 1107-2020, Lebanon

Location

Related Links

• St. Jude Children's Research Hospital

Biospecimen

Retention: SAMPLES WITHOUT DNA

A trained phlebotomist will collect a tube of blood (7.5ml) in serum separator tubes. The blood will be allowed to clot at room temperature then centrifuged on the same day. Serum specimens will be aliqouted into multiple cryovials, labelled and preserved at -20°C until ready for laboratory study.

MeSH Terms

Conditions

Influenza in Birds; Virus Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohammad Ghazi Kayali, Ph.D, MPH

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 20, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 27, 2011

Record last verified: 2011-10

Locations

US (1); LE (1)