Prospective Study of AI H5N1 in China

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00428493
First received: January 25, 2007
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to see if people in China who have contact with someone infected with bird flu (H5N1) become infected themselves without necessarily getting sick. Adults and children greater than 1 year of age who have contact with someone infected with bird flu may participate in the study. At the first 1-2 study visits, a blood sample will be taken from volunteers in order to test for antibodies, the part of the blood that fights infection. If the result of the H5N1 antibody test is positive after the 1st or 2nd study visit, an additional blood sample will be collected during a 3rd and 4th study visit. Volunteers will be asked questions about their work, home life, and possible contact with poultry, other birds, animals, and people infected with bird flu. Participants will be involved in study related procedures for up to 90 days.


Condition
Influenza

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Study of Individuals Exposed to Confirmed Cases of Human Influenza A (H5N1) Infection in China

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 4000
Study Start Date: January 2007
Estimated Study Completion Date: January 2008
Detailed Description:

This will be a prospective cohort study of individuals exposed to confirmed cases of Human Influenza A (H5N1) infection in China. The study will be conducted over a period of approximately one year. Adults and children, greater than age 1, who meet the eligibility criteria will be consented and enrolled in the study. These subjects will undergo up to two blood draws for serologic testing of the presence of H5N1 antibodies according to an algorithm. These subjects will also be administered a structured questionnaire for collection of demographic information, information on potential exposure to poultry, other birds or animals, or infected humans and any clinical symptoms. This questionnaire will have similar data elements to the questionnaires used in the past for collection by the China CDC. The questionnaires were administered in areas of China where there have been poultry and human cases, as well as, other high risk populations in non-outbreak areas. Enrolled participants will complete two study visits no more than one month apart with a third visit for those who test positive for influenza A H5N1 infection. Participants who consent to HIV testing will have a fourth visit to obtain their HIV test results. The primary study objective is to determine the prevalence of antibodies to avian influenza A (H5N1) virus among close contacts and health care workers associated with confirmed H5N1 infected individuals in China. The secondary study objectives are to: describe risk factors for human infection with avian influenza A (H5N1) virus in China; evaluate the incidence of seroconversion and increases in titer of H5N1 antibodies; describe risk factors associated with seroconversion and increases in titer of H5N1 antibodies; determine T-cell immune responses in H5N1 infected individuals; and determine the prevalence of co-infection of H5N1 and HIV-1. The primary endpoint is detection of avian influenza H5N1 infection as determined by a positive result on Hemagglutination Inhibition (HI) and confirmed by Microneutralization (MN). Corresponding with the secondary study objectives, the following will be assessed as secondary study endpoints: association of risk factors with avian influenza seropositivity, including demographic characteristics and various exposures to poultry, other birds, and to infected humans; H5N1 serum antibody titer seroconversion or a greater than or equal to 4-fold increase in titer; association of risk factors with avian influenza seroconversion, including demographic characteristics and various exposures to poultry, other birds, and to infected humans; HIV-1 infection as determined by ELISA and Western Blot assays and co-infection of H5N1 and HIV-1 as determined by both assays described above; and T-cell responses to H5N1 as determined by ELISPOT assay and ICS.

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Informed consent for study participation provided by the volunteer or, for children, by a parent or legal guardian. Children aged 10-18 will be asked to assent.
  2. Adults and children > 1 year old.
  3. Close contacts or health care worker of confirmed human H5N1 case.

Exclusion Criteria:

1. Children under 12 months old.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428493

Locations
China
Chinese Center for Disease Control and Prevention
Beijing, China, 100052
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00428493     History of Changes
Other Study ID Numbers: 06-0055
Study First Received: January 25, 2007
Last Updated: May 29, 2008
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
human influenza A, H5N1, bird flu, avian influenza, China

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 25, 2014