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Study to Eliminate Hib Carriage in Rural Alaska Native Villages

This study has been completed.
Sponsor:
Collaborators:
CDC-Arctic Investigations Program
Alaska Native Tribal Health Consortium
Yukon Kuskokwim Health Corporation
Alaska State Public Health Laboratories
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153556
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 8, 2005
September 8, 2005
September 2001
Not Provided
Change in community-wide oropharyngeal Hib colonization one year after administration of a single dose of Hib vaccine to all willing community members in 3 villages vs. change in HIb colonization in 3 village where Hib vaccine was used routinely
Same as current
No Changes Posted
  • - Safety of HIb vaccine given to adults
  • - Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls
  • - Risk factors for Hib colonization
Same as current
Not Provided
Not Provided
 
Study to Eliminate Hib Carriage in Rural Alaska Native Villages
A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages

Hib disease rates in rural Alaska before introduction of HIb conjugate vaccine were among the highest in the world. Since vaccine introduction, rates have fallen by 90% but the disease has not been eliminated. This study is designed to test one possible means of eliminating Hib carriage and thus to eliminate person to person transmission and invasive disease.

The objective of this study is to evaluate the effectiveness of community-wide use of Hib conjugate vaccine for eliminating oropharyngeal Hib carriage in rural Alaska villages.

Secondary objectives include:

  • Determine risk factors for Hib OP carriage including demographic characteristics, and immunologic characteristics (antibody level and function). This will be accomplished through a case-control study described below.
  • Measure antibody response to Hib conjugate vaccine among adults who have not previously received Hib vaccine. This will be accomplished through a cohort study of participating adults in the vaccine intervention communities.

This was a pilot intervention to assess the feasibility of using Hib conjugate vaccine to eliminate Hib carriage in rural Alaska villages, with three villages to serve as a comparison group. WE performed community-wide surveys of Hib carriage by recruiting volunteers for throat cultures to establish a baseline rate of Hib carriage for each community. Then Hib carriers were offered chemoprophylaxis to clear Hib from their throats. In the vaccine intervention communities, a single dose of Hib conjugate vaccine was offered to persons of all ages. This was followed by a second community-wide Hib carriage survey after one year to assess the effectiveness of the intervention.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Haemophilus Influenzae Type B
  • Carrier State
Biological: Hib conjugate vaccine (HbOC, Wyeth Vaccines)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3200
November 2003
Not Provided

Inclusion Criteria:

  • All village residents are eligible for Hib colonization survey
  • All residents of selected villages eligible for vaccine study except as noted below.

Exclusion Criteria:

  • For receipt of vaccine:
  • history of allergic reaction to Hib vaccine or components
  • Age < 24 months and not due for Hib vaccine according to childhood immunization schedule
  • Age > 24 months and have received HIb vaccine within past year
  • Pregnant
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00153556
CDC-NCID-2961
Not Provided
Not Provided
Centers for Disease Control and Prevention
  • CDC-Arctic Investigations Program
  • Alaska Native Tribal Health Consortium
  • Yukon Kuskokwim Health Corporation
  • Alaska State Public Health Laboratories
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Thomas W Hennessy, MD,MPH Centers for Disease Control and Prevention-Arctic Investigations Program
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP