Trial | NCT00153556  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3200
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.
Study Started
Sep 30
2001
Study Completion
Nov 30
2003
Last Update
Sep 12
2005
Estimate

Biological Hib conjugate vaccine (HbOC, Wyeth Vaccines)

Criteria 

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
No Results Posted