Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease (PNEUMO)

April 22, 2015 updated by: University of Minnesota

Pneumococcal Vaccine Response in COPD

Pneumococcal disease is a serious bacterial infection that can affect different parts of the body, including the lungs. People with chronic illnesses, such as chronic obstructive pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a result of pneumococcal disease. This study will compare the immune response to two types of pneumococcal vaccines in adults with COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals who are infected with the Streptococcus pneumoniae bacteria may develop pneumococcal disease, a serious disease that kills more people in the United States than all other vaccine-preventable diseases combined. Individuals with COPD, characterized by breathing difficulties due to damaged and obstructed lung airways, may have an increased risk of developing serious complications from pneumococcal disease, including pneumonia and meningitis. Currently, there are two types of pneumococcal vaccines available. The pneumococcal capsular polysaccharide (CPS) vaccine, known as Pneumovax, is typically given to adults 65 years of age or older and to any individuals with a serious health condition, including heart disease, lung disease, and diabetes. The diphtheria protein-conjugated vaccine (PCV7), known as Prevnar, is typically given to infants; however, adults who receive this vaccine may also have a favorable response. The purpose of this study is to compare the immune response to the Pneumovax and Prevnar vaccines in adults with COPD.

This study will enroll adults with mild to moderate COPD. Participants will be randomly assigned to receive either the Pneumovax or Prevnar vaccine. This will involve one or two injections. Blood collection will occur during study visits at Months 1, 12, and 24. Study researchers will contact participants by telephone at Months 6 and 18 to document any pneumococcal infections and any additional pneumococcal vaccinations.

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35294-0006
        • Veteran's Administration Medical Center
    • California
      • Los Angeles, California, United States, 90502
        • LA BioMed at Harbor, University of California
      • San Francisco, California, United States, 94143
        • University of California San Francisco-Airway Clinical Research Center
    • Colorado
      • Denver, Colorado, United States, 80204-4507
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80220
        • Veteran's Administration Medical Center
      • Denver, Colorado, United States, 80204-4507
        • National Jewish Medical and Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02132
        • Veteran's Administration Medical Center
      • Boston, Massachusetts, United States, 02115
        • Fallon Clinic
      • Boston, Massachusetts, United States, 02132
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Veteran's Administration Medical Center
      • Ann Arbor, Michigan, United States, 48109-0360
        • University of Michigan Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55440
        • HealthPartners Research Foundation
      • Minneapolis, Minnesota, United States, 55417
        • Veteran's Administration Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Lung Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Emphysema Research Center

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

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

  • Post-bronchodilator forced expiratory volume at one second

    /forced vital capacity (FEV1/FVC) level less than 70%

  • Ten or more pack-years of smoking
  • Willing to make return visits to the study clinic and accept telephone contact
  • Last pneumococcal vaccination occured at least 5 years prior to study entry

Exclusion Criteria:

  • Asthma
  • Sensitivity to pneumococcal vaccine
  • Known bleeding disorder, or requires long-term anticoagulation therapy
  • Presence of chronic disease that may impair pneumococcal vaccine response
  • Acute illness requiring antibiotics in the month prior to study entry
  • Medical condition that makes survival for 24 months following study entry unlikely
  • Pregnant

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pneumovax (PPSV23)
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
Biological: Pneumovax (PPSV23)
Injection
Other Names:
  • Pneumovax
  • PPSV23
  • 23-valent pneumococcal capsular polysaccharide vaccine
Active Comparator: Prevnar (PCV7)
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
Biological: Prevnar (PCV7)
Injection
Other Names:
  • Prevnar
  • PCV7
  • 7-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype Opsonization Titers
Time Frame: Measured at Baseline, Months 1, 12, and 24
Opsonophagocytosis activity (OPK) serotype specific geometric means
Measured at Baseline, Months 1, 12, and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Time Frame: Measured at Baseline, Months 1, 12, and 24
Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)
Measured at Baseline, Months 1, 12, and 24

Collaborators and Investigators

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

Sponsor

University of Minnesota

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Study Director: Antonello Punturieri, MD, National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 5, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 9, 2007

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 477
  • U10HL074424 (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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