Haemophilus Influenzae Type B Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 3200 |
Est. completion date | November 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | CDC Arctic Investigations Program | Anchorage | Alaska |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | Alaska Native Tribal Health Consortium, Alaska State Public Health Laboratories, CDC-Arctic Investigations Program, National Institute of Allergy and Infectious Diseases (NIAID), Yukon Kuskokwim Health Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | - Safety of HIb vaccine given to adults | |||
Secondary | - Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls | |||
Secondary | - Risk factors for Hib colonization |
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