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Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage

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ClinicalTrials.gov Identifier: NCT00294021
Recruitment Status : Completed
First Posted : February 20, 2006
Last Update Posted : September 26, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Pneumococcal Infections

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.

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
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
Study Start Date : March 2006
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples Without DNA
Nasopharyngeal specimens will be collected for isolation of pneumococcus; saliva and serum specimens will be collected for antibody assays

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Centers for Disease Control and Prevention
Institute of Child Health
Finnish Public Health Institute
Thrasher Research Fund
Grand Challenges in Global Health
Investigators
Principal Investigator: Katherine L O'Brien, MD, MPH Johns Hopkins Center for American Indian Health
More Information

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
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs