ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Eliminate Hib Carriage in Rural Alaska Native Villages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00153556
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sponsor:
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)
Information provided by:
Centers for Disease Control and Prevention

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.

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

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  (Clinical Trial)
Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages
Study Start Date : September 2001
Study Completion Date : November 2003

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. - Safety of HIb vaccine given to adults
  2. - Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls
  3. - Risk factors for Hib colonization


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153556


Locations
United States, Alaska
CDC Arctic Investigations Program
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Centers for Disease Control and Prevention
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)
Investigators
Principal Investigator: Thomas W Hennessy, MD,MPH Centers for Disease Control and Prevention-Arctic Investigations Program

ClinicalTrials.gov Identifier: NCT00153556     History of Changes
Other Study ID Numbers: CDC-NCID-2961
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: September 2005

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:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs