Study to Eliminate Hib Carriage in Rural Alaska Native Villages
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|ClinicalTrials.gov Identifier: NCT00153556|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Haemophilus Influenzae Type B Carrier State||Biological: Hib conjugate vaccine (HbOC, Wyeth Vaccines)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages|
|Study Start Date :||September 2001|
|Estimated Study Completion Date :||November 2003|
- 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
- - 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153556
|United States, Alaska|
|CDC Arctic Investigations Program|
|Anchorage, Alaska, United States, 99508|
|Principal Investigator:||Thomas W Hennessy, MD,MPH||Centers for Disease Control and Prevention-Arctic Investigations Program|