Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage

This study has been completed.
Sponsor:
Collaborators:
Institute of Child Health
Finnish Public Health Institute
Thrasher Research Fund
Gates Grand Challenges
Information provided by (Responsible Party):
Katherine O'Brien, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00294021
First received: February 17, 2006
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition
Pneumococcal Infections

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Long-term Impact of the Pneumococcal Conjugate Vaccine on Pneumococcal Nasopharyngeal Colonization and Immune Correlates for Disease Protection

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Biospecimen Retention:   Samples Without DNA

Nasopharyngeal specimens will be collected for isolation of pneumococcus; saliva and serum specimens will be collected for antibody assays


Estimated Enrollment: 1000
Study Start Date: March 2006
Study Completion Date: April 2008
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults and children living on the Navajo or White Mountain Apache reservations

Criteria

Inclusion Criteria for the Family to Participate.

  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

Exclusion Criteria for the Family to Participate.

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

Inclusion Criteria for Individuals.

  1. Living in the household
  2. Willing to participate for a 6-month time period

Exclusion Criteria for Individuals.

1. Congenital anomalies of the nasopharynx

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294021

Locations
United States, Arizona
Johns Hopkins Center for American Indian Health
Chinle, Fort Defiance, Whiteriver, AZ; Gallup, Shiprock, NM, Arizona, United States
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Institute of Child Health
Finnish Public Health Institute
Thrasher Research Fund
Gates Grand Challenges
Investigators
Principal Investigator: Katherine L O'Brien, MD, MPH Johns Hopkins Center for American Indian Health
  More Information

No publications provided

Responsible Party: Katherine O'Brien, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00294021     History of Changes
Other Study ID Numbers: CAIH-LTNP
Study First Received: February 17, 2006
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014