A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults
NCT07019883
Animal Diseases, Avian Influenza
Durham, North Carolina, United States
View Trial DetailsNCT Number: NCT01107262
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.
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Notify Me18 year and older
All sexes
Observational
American University of Beirut, Beirut, Lebanon
This study will examine the sera of 200 poultry-exposed adults and 50 adult controls and administer questionnaires to identify risk factors for AI infections in human beings.Study volunteers will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. A blood sample will be collected from every participant to verify presence of antibodies against the viruses under study. All study materials are in English and Arabic. Along side the human aspect of the study, specimens will be collected from the birds that the individual handles.
This study hypothesizes that they will find evidence of previous infection with these viruses among poultry workers. Furthermore, the study team will collect animal specimens from the farms of the study volunteers and determine the types of Avian Influenza viruses that they harbour.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
St. Jude Children's Research Hospital
Other
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