China Case Control Avian Influenza
China Case Control Avian Influenza
This study will determine risk factors of human infection with avian influenza A virus, also
 known as bird flu virus. Certain risk factors such as exposure to poultry, travel history,
 health status, and other factors may affect one's risk of getting bird flu. Study
 participants will include individuals, older than age 1, that tested positive for influenza A
 (H5N1) in a previous surveillance program and controls (individuals that have not tested
 positive for avian influenza A (H5N1) and have no fever or respiratory symptoms). There will
 be 1 study visit during which volunteers will be asked detailed questions about their health,
 work, and travel habits. Study participants will be asked to donate a blood sample to test
 for antibodies, the part of the blood that fights infection.
This study is a matched case-control study of risk factors for human infection with avian
 influenza A (H5N1) virus in China. The primary study objective is to determine the risk
 factors for avian influenza A (H5N1) virus infection in humans, in China, whether or not the
 subject was symptomatic. The confirmed case-patients and confirmed antibody positive avian
 influenza A (H5N1) persons (asymptomatic or sub-clinical) identified by the previously done
 National Surveillance Program will be included in this study as cases. Controls will be
 identified from population registries in villages with rural cases and in the adjacent
 apartment buildings of the urban cases' residences. If the National Surveillance Program
 identifies healthcare workers infected with avian influenza A (H5N1) virus, healthcare
 workers in the same department of the healthcare facilities in which the cases worked will
 also be included as controls. A matched case-control study will be conducted with a ratio of
 4 controls per 1 case. Cases and controls who meet the eligibility criteria will be consented
 and enrolled in the study. After enrollment a questionnaire will be administered to obtain
 information on demographic characteristics, underlying diseases, daily activities, shopping
 habits, poultry raising in the backyard, poultry vaccination, exposure to sick/dead poultry
 or healthy appearing poultry, visits to places where live poultry were kept (e.g., poultry
 stalls, retail markets, wholesale markets or poultry farms) in the week before illness,
 eating habits, food preparation activities related to poultry, children's activities such as
 playing with poultry and swimming in water with water fowl, exposure to other animals
 including wild birds, and exposure to other humans with respiratory illnesses or confirmed
 H5N1 case-patients. Survived cases, individuals whose specimen H5N1 tested positive in
 previous National Surveillance Program and controls will be asked to provide a blood sample
 to determine whether they have antibodies to H5N1. New confirmed cases and controls will be
 asked to donate a blood sample for H5N1 antibody testing. Any control that tests positive
 will become a case and additional controls will be identified. All samples will be tested for
 H5N1 antibodies with hemagglutination inhibition (using horse red blood cells) and
 microneutralization assay. If all negative, the individual will be considered sero-negative;
 if all positive, the individual will be considered sero-positive for the purposes of this
 study; if results from hemagglutination inhibition (HI) and microneutralization (MN) assays
 are discordant, the MN result will be considered the final result (negative or positive).
 Appropriate antigens for the assays will be selected based on the antigenic characteristics
 of the virus circulating in the region at the time of sample collection. HI and MN assays
 will be performed according to accepted SOPs. The study will be completed within one year.
Inclusion Criteria:

 Participants should be informed and assent to participate in this study. For children,
 informed consent should be provided by their parents or legal guardians. Children aged from
 10 years old to 18 years old will be asked to assent.

 -  Adults or children older than 1 year old.

 -  Satisfying above definition of cases and controls

 Exclusion Criteria:

 -  Infants younger than 12 months

 -  For any cases or controls who need proxy, they should be excluded under below
 situations:

 1. Proxy can not provide sufficient information for this study, or

 2. Proxy refuses to participate in this study, or

 3. No suitable proxy can be found.