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Completed

NCT Number: NCT00153556

Study to Eliminate Hib Carriage in 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.

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Key information

Conditions

Haemophilus Influenzae Type b Bacterial Infections Bacterial Infections and Mycoses Carrier State Gram-Negative Bacterial Infections Haemophilus Infections Infections Pasteurellaceae Infections

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CDC Arctic Investigations Program

Anchorage, Alaska, 99508, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hib conjugate vaccine (HbOC, Wyeth Vaccines)

Biological

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

  1. - Safety of HIb vaccine given to adults

  2. - Anti-PRP antibody/ avidity/ serum bacteriocidal activity among adult vaccine recipients, Hib colonized persons and age-matched controls

  3. - Risk factors for Hib colonization

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • 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

Registry information

Official study title

A Demonstration Project for the Elimination of Haemophilus Influenzae Type B in Three Rural Alaska Native Villages

Important dates

Study start
2001
Study completion
2003
First posted
Sep 12, 2005
Registry last updated
Sep 12, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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