Study to Eliminate Hib Carriage in Rural Alaska Native Villages

This study has been completed.
Sponsor:
Collaborators:
CDC-Arctic Investigations Program
Alaska Native Tribal Health Consortium
Yukon Kuskokwim Health Corporation
Alaska State Public Health Laboratories
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153556
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Haemophilus Influenzae Type B
Carrier State
Biological: Hib conjugate vaccine (HbOC, Wyeth Vaccines)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

Estimated Enrollment: 3200
Study Start Date: September 2001
Estimated Study Completion Date: November 2003
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153556

Locations
United States, Alaska
CDC Arctic Investigations Program
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
CDC-Arctic Investigations Program
Alaska Native Tribal Health Consortium
Yukon Kuskokwim Health Corporation
Alaska State Public Health Laboratories
Investigators
Principal Investigator: Thomas W Hennessy, MD,MPH Centers for Disease Control and Prevention-Arctic Investigations Program
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00153556     History of Changes
Other Study ID Numbers: CDC-NCID-2961
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
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

Additional relevant MeSH terms:
Haemophilus Infections
Influenza, Human
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014