Study to Eliminate Hib Carriage in Rural Alaska Native Villages

September 8, 2005 updated by: Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

3200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • CDC Arctic Investigations Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Alaska Native Tribal Health Consortium
Yukon Kuskokwim Health Corporation
CDC-Arctic Investigations Program
Alaska State Public Health Laboratories

Investigators

  • Principal Investigator: Thomas W Hennessy, MD,MPH, Centers for Disease Control and Prevention-Arctic Investigations Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

November 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2005

Last Update Submitted That Met QC Criteria

September 8, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCID-2961

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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