Clinical trial NCT00153556: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: CDC-Arctic Investigations Program
name: Alaska Native Tribal Health Consortium
name: Yukon Kuskokwim Health Corporation
name: Alaska State Public Health Laboratories
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-09-12
Enrollment: 3200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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 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

Primary outcomes:
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
Secondary outcomes:
measure: - Safety of HIb vaccine given to adults
measure: - Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls
measure: - Risk factors for Hib colonization
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: CDC Arctic Investigations Program
state: Alaska
Study officials:
affiliation: Centers for Disease Control and Prevention-Arctic Investigations Program
name: Thomas W Hennessy, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: