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Study to Eliminate Hib Carriage in Rural Alaska Native Villages

Primary Purpose

Haemophilus Influenzae Type B, Carrier State

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hib conjugate vaccine (HbOC, Wyeth Vaccines)
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type B focused on measuring Haemophilus influenza type B, Carrier state, Bacterial Vaccines, Anti-PRP antibody, Antibody avidity, Serum bacteriocidal antibody, American Indians/Alaska Natives, Case control study, Adult vaccines

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CDC Arctic Investigations Program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

- 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

Full Information

First Posted
September 8, 2005
Last Updated
September 8, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
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)
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1. Study Identification

Unique Protocol Identification Number
NCT00153556
Brief Title
Study to Eliminate Hib Carriage in Rural Alaska Native Villages
Official Title
A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
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)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type B, Carrier State
Keywords
Haemophilus influenza type B, Carrier state, Bacterial Vaccines, Anti-PRP antibody, Antibody avidity, Serum bacteriocidal antibody, American Indians/Alaska Natives, Case control study, Adult vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Hib conjugate vaccine (HbOC, Wyeth Vaccines)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
- Safety of HIb vaccine given to adults
Title
- Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls
Title
- Risk factors for Hib colonization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas W Hennessy, MD,MPH
Organizational Affiliation
Centers for Disease Control and Prevention-Arctic Investigations Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDC Arctic Investigations Program
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Eliminate Hib Carriage in Rural Alaska Native Villages

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