Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage

Long-term Impact of the Pneumococcal Conjugate Vaccine on Pneumococcal Nasopharyngeal Colonization and Immune Correlates for Disease Protection

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chinle, Fort Defiance, Whiteriver, AZ; Gallup, Shiprock, NM, Arizona, United States
      • Johns Hopkins Center for American Indian Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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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Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Centers for Disease Control and Prevention; Institute of Child Health; Thrasher Research Fund; Finnish Public Health Institute; Grand Challenges in Global Health
• Investigators: Principal Investigator: Katherine L O'Brien, MD, MPH, Johns Hopkins Center for American Indian Health

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: February 17, 2006
• First Submitted That Met QC Criteria: February 17, 2006
• First Posted (Estimate): February 20, 2006

Study Record Updates

• Last Update Posted (Estimate): September 26, 2012
• Last Update Submitted That Met QC Criteria: September 25, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections
• Other Study ID Numbers: CAIH-LTNP