Study to Eliminate Hib Carriage in Rural Alaska Native Villages
Information source: Centers for Disease Control and Prevention
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Haemophilus Influenzae Type B; Carrier State
Intervention: Hib conjugate vaccine (HbOC, Wyeth Vaccines) (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s):
Thomas W Hennessy, MD,MPH, Principal Investigator, Affiliation: Centers for Disease Control and Prevention-Arctic Investigations Program
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.
Clinical Details
Official title: A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages
Study design: Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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: - 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
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CDC Arctic Investigations Program, Anchorage, Alaska 99508, United States
Additional Information
Starting date: September 2001
Ending date: November 2003
Last updated: September 8, 2005
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