Impact of PCV on Disease and Colonization Among Native American Communities

January 16, 2015 updated by: Katherine O'Brien, Johns Hopkins Bloomberg School of Public Health
The purpose of this study is to determine the impact of pneumococcal conjugate vaccine on carriage of pneumococcus in the nasopharynx and on the incidence of invasive pneumococcal disease in the community.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Pneumococcus is a bacterium that healthy people commonly have in their nose and throat; this is called pneumococcal 'carriage'. Carriage is usually harmless, but can progress to serious disease like pneumonia, meningitis, and blood stream infections or to less serious, but burdensome, diseases like sinusitis or ear infections. Infants and the elderly bear the greatest burden of pneumococcal disease with over 800,000 annual global deaths from this germ among children under 5 years of age. Furthermore, pneumococcus has developed resistance to antibiotics making it increasingly difficult to treat pneumococcal infections. Within the United States some Native American groups, like the Navajo and the White Mountain Apache tribes, suffer from pneumococcal disease much more often than people in the general US population. We don't know why pneumococcus disproportionately afflicts these communities, but we know this health disparity can be significantly reduced through vaccination. In 2000, for the first time a pneumococcal vaccine designed specifically for infants, called PCV7, became available and was put into routine use among Navajo and Apache as well as the general US population. PCV7 contains the 7 most common of the >90 pneumococcal strains that exist. Although PCV7 is only given to infants and toddlers, it impacts pneumococcal disease throughout the community because it not only protects vaccinated infants from disease it also protects them against NP colonization. Infants and children are the main transmitters of pneumococcal colonization in the community so any change in their carriage affects the whole population of pneumococcal germs circulating within the family and community. Reductions in pneumococcal disease caused by the 7 types in PCV7 have exceeded expectations, especially among Navajo and Apache where we have seen virtually no cases in over 5 years. But, PCV7 has had the unintended consequence of increasing the amount of pneumococcal disease from some pneumococcal types that are not in PCV7. Therefore a new vaccine to protect against 13 pneumococcal strains, called PCV13, has been developed and is about to be licensed and used (expected licensure Q4/2009). This project aims to reveal the impact of PCV13 on pneumococcal disease and carriage of strains which move from person to person within the Navajo community. We specifically intend to find out if use of PCV13 has an effect on disease and carriage of the 6 additional strains in the vaccine and to find out if PCV13 will result in the emergence of new pneumococcal serotypes within the community, like PCV7 did. This information will allow us to design vaccine strategies to meet these new patterns of pneumococcal disease and stay at least one step ahead of the organism changes. It will also provide the evidence on which rational policies for PCV13 use among Navajo can be made. This has been essential information in past experiences of vaccine shortages, where Navajo communities were given priority for vaccine use. We also propose to explore the correlations between pneumococcal colonization and viral infection of the nasopharynx to establish if there is enhanced risk of pneumococcal colonization in the setting of viral co-infection and if that enhances the risk of developing disease. To achieve the overall objectives we propose pulling together three types of information (1) effect of PCV13 on nasopharyngeal colonization with pneumococcus and viral pathogens (2) effect of PCV13 on disease and (3) use of PCV13 in the community.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Whiteriver, Arizona, United States
        • White Mountain Apache reservation
    • New Mexico
      • Gallup, New Mexico, United States
        • Navajo reservation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population for the nasopharyngeal study is American Indian children 7-24 months of age (index child) and their adult and child household members who reside in the Whiteriver, Shiprock, Chinle, Fort Defiance and Gallup service units on the White Mountain Apache and Navajo reservations. In addition those children and adults who have close contact with the index child but may not live in the same household as the child are eligible to participate. This may be relatives or close contacts of the index child who reside in the same family compound (a compound is a group of homes in close proximity to each other) but do not live in the same household as the index child.

Description

Inclusion Criteria:

  • American Indian children and their families (i.e. people of all ages) who live in the Whiteriver, Fort Defiance, Chinle, Gallup, Shiprock Service Units are eligible to participate in the carriage portion of the study.

Exclusion Criteria:

  • Anyone with a congenital anomaly of the nasopharynx would not be eligible to participate in the carriage portion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
PCV13 immunized
Children who receive the 13-valent pneumococcal conjugate vaccine
PCV13 unimmunized
PCV13 unimmunized Household members of PCV13 immunized children

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Nasopharyngeal carriage or Invasive Pneumococcal Disease caused by a PCV13 serotype
Time Frame: Before PCV13 introduction and after 1 and 2 years of PCV13 use
Before PCV13 introduction and after 1 and 2 years of PCV13 use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer
National Institutes of Health (NIH)
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine L O'Brien, MD, Johns Hopkins Bloomberg School of Public Health
  • Principal Investigator: Lindsay R Grant, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MD004011-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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