Study to Eliminate Hib Carriage in Rural Alaska Native Villages

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-11-30

Brief Summary

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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

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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.

Conditions

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Haemophilus Influenzae Type B Carrier State

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Hib conjugate vaccine (HbOC, Wyeth Vaccines)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Thomas W Hennessy, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention-Arctic Investigations Program

Locations

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CDC Arctic Investigations Program

Anchorage, Alaska, United States

Site Status

Countries

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United States

Other Identifiers

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CDC-NCID-2961

Identifier Type: -

Identifier Source: org_study_id