Clinical trial NCT00294021: Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage
Official title: Long-term Impact of the Pneumococcal Conjugate Vaccine on Pneumococcal Nasopharyngeal Colonization and Immune Correlates for Disease Protection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infections
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Institute of Child Health
name: Finnish Public Health Institute
name: Thrasher Research Fund
name: Grand Challenges in Global Health
First posted: 2006-02-20
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children living on the Navajo or White Mountain Apache reservations

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.

Eligibility 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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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chinle, Fort Defiance, Whiteriver, AZ; Gallup, Shiprock, NM
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
Study officials:
affiliation: Johns Hopkins Center for American Indian Health
name: Katherine L O'Brien, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: