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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00153556
Other study ID # CDC-NCID-2961
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated September 8, 2005
Start date September 2001
Est. completion date November 2003

Study information

Verified date September 2005
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Hib conjugate vaccine (HbOC, Wyeth Vaccines)


Locations

Country Name City State
United States CDC Arctic Investigations Program Anchorage Alaska

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

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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