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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00457977
First received: April 5, 2007
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Biological: Pneumovax (CPS)
Biological: Prevnar (PCV7)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pneumococcal Vaccine Response in COPD

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Serotype-specific opsonization titers [ Time Frame: Measured at Months 1, 12, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serotype-specific antibody levels [ Time Frame: Measured at Months 1, 12, and 24 ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: March 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pneumovax (CPS)
pneumococcal capsular polysaccharide vaccine (CPS) (Pneumovax)
Biological: Pneumovax (CPS)
Injection
Other Names:
  • 23-valent pneumococcal capsular polysaccharide vaccine
  • CPS
  • Pneumovax
Active Comparator: Prevnar (PCV7)
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
Biological: Prevnar (PCV7)
Injection
Other Names:
  • 7-valent pneumococcal conjugate vaccine
  • PCV7
  • Prevnar

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • Post-bronchodilator 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457977

Locations
United States, Alabama
Veteran's Administration Medical Center
Birmingham, Alabama, United States, 35294-0006
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
LA BioMed at Harbor, University of California
Los Angeles, California, United States, 90502
University of California San Francisco-Airway Clinical Research Center
San Francisco, California, United States, 94143
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204-4507
National Jewish Medical and Research Center
Denver, Colorado, United States, 80204-4507
Veteran's Administration Medical Center
Denver, Colorado, United States, 80220
United States, Maryland
University of Maryland Hospital
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02132
Fallon Clinic
Boston, Massachusetts, United States, 02115
Veteran's Administration Medical Center
Boston, Massachusetts, United States, 02132
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0360
Veteran's Administration Medical Center
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Veteran's Administration Medical Center
Minneapolis, Minnesota, United States, 55417
HealthPartners Research Foundation
Minneapolis, Minnesota, United States, 55440
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Emphysema Research Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Study Director: Antonello Punturieri, MD National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00457977     History of Changes
Other Study ID Numbers: 477, U10HL074424
Study First Received: April 5, 2007
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Chronic Obstructive Pulmonary Disease
COPD
Pneumococcal
Vaccine
Opsonization
Antibodies

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014