Expired Study
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Anchorage, Alaska 99508


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDC-NCID-2961


NCT ID:

NCT00153556


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Centers for Disease Control and Prevention


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

3200


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:September 2001
Completion Date:November 2003
Verification Date:September 2005
Last Changed Date:September 8, 2005
First Received Date:September 8, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:- Risk factors for Hib colonization
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:- Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:- Safety of HIb vaccine given to adults
Safety Issues:False
Outcome Type:Primary 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
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:Hib conjugate vaccine (HbOC, Wyeth Vaccines)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Centers for Disease Control and Prevention
Agency Class:Other
Agency Type:Collaborator
Agency Name:CDC-Arctic Investigations Program

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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