Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage

NCT ID: NCT00294021

Last Updated: 2012-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-04-30

Brief Summary

Pneumococcus is a major cause of morbidity and mortality. In 2000, a pneumococcal conjugate vaccine (PCV) was licensed for use in children and is now part of the routine childhood vaccine schedule. PCV is known to reduce invasive disease and protect against nasopharyngeal (NP) acquisition of vaccine serotype pneumococci; it also results in an increased risk of nonvaccine serotype carriage. This study proposes to assess the longterm impact of vaccine on NP carriage in a setting where there is intense antibody pressure on the ecology of the pneumococcus. A cross sectional study of pneumococcal NP colonization among American Indian children will be combined with surveillance for invasive disease in the same population. The purpose is to determine the impact of community wide PCV use on NP colonization and the relationship with invasive disease. This longterm safety issue needs to be assessed to fully evaluate the impact of vaccine on NP ecology and invasive disease.

Detailed Description

There are four specific aims for this study: (1) to determine the overall and serotype specific prevalence and incidence of pneumococcal carriage among children and adults at high risk for carriage and disease in the era of routine pneumococcal conjugate vaccine (PCV) use compared with those measures in the same population prior to use of PCV vaccine; (2) to characterize the intrafamilial NP transmission of clones among those living with children less than 8 years of age; (3) to determine the immune correlates of protection from serotype specific pneumococcal carriage among individuals immunized and not immunized with PCV; and (4) to determine the relative invasiveness of serotypes of pneumococcus during an era of widespread PCV use and compare this to the relative invasiveness of serotypes prior to routine use of PCV.

Conditions

Pneumococcal Infections

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. At least one parent is a member of the Navajo or White Mountain Apache Tribe

2. Family home is on or near the Navajo or Apache reservation

3. At least one child in the household is 8 years of age or younger (minimum age of eligibility: birth)

4. At least one child in the household is fully immunized with Prevnar.

5. At least two people in the household will participate in the study

6. Willingness to participate for a 6-month time period

1. Living in the household

2. Willing to participate for a 6-month time period

Exclusion Criteria

1. Family will be moving off reservation during the study period

1. Congenital anomalies of the nasopharynx

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• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Institute of Child Health

OTHER

Sponsor Role: collaborator

Finnish Public Health Institute

UNKNOWN

Sponsor Role: collaborator

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Grand Challenges in Global Health

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Katherine O'Brien

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine L O'Brien, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Center for American Indian Health

Locations

Johns Hopkins Center for American Indian Health

Chinle, Fort Defiance, Whiteriver, AZ; Gallup, Shiprock, NM, Arizona, United States

Countries

United States

Other Identifiers

CAIH-LTNP

Identifier Type: -

Identifier Source: org_study_id