Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage

NCT00294021 | Completed

• 1 other identifier: CAIH-LTNP
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Infections

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• At least one parent is a member of the Navajo or White Mountain Apache Tribe
• Family home is on or near the Navajo or Apache reservation
• At least one child in the household is 8 years of age or younger (minimum age of eligibility: birth)
• At least one child in the household is fully immunized with Prevnar.
• At least two people in the household will participate in the study
• Willingness to participate for a 6-month time period

You may not qualify if:

• \. Family will be moving off reservation during the study period
• Living in the household
• Willing to participate for a 6-month time period
• \. Congenital anomalies of the nasopharynx

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Centers for Disease Control and Prevention: collaborator
• Institute of Child Health: collaborator
• Finnish Public Health Institute: collaborator
• Thrasher Research Fund: collaborator
• Grand Challenges in Global Health: collaborator

Study Sites (1)

Johns Hopkins Center for American Indian Health

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Katherine L O'Brien, MD, MPH

  Johns Hopkins Center for American Indian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 20, 2006
• Study Start: March 1, 2006
• Study Completion: April 1, 2008
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

US (1)