Study to Eliminate Hib Carriage in Rural Alaska Native Villages

NCT00153556 | Completed Phase 4

• 1 other identifier: CDC-NCID-2961
• Study Type: interventional
• Target: 3,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Haemophilus Influenzae Type B; Carrier State

Keywords

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

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• - 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

Interventions

Hib conjugate vaccine (HbOC, Wyeth Vaccines) BIOLOGICAL

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All village residents are eligible for Hib colonization survey
• All residents of selected villages eligible for vaccine study except as noted below.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• CDC-Arctic Investigations Program: collaborator
• Alaska Native Tribal Health Consortium: collaborator
• Yukon Kuskokwim Health Corporation: collaborator
• Alaska State Public Health Laboratories: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

CDC Arctic Investigations Program

Anchorage, Alaska, 99508, United States

Location

MeSH Terms

Conditions

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Thomas W Hennessy, MD,MPH

  Centers for Disease Control and Prevention-Arctic Investigations Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2001
• Study Completion: November 1, 2003
• Last Updated: September 12, 2005

Record last verified: 2005-09

Locations

US (1)