Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00457977
Recruitment Status : Completed
First Posted : April 9, 2007
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Biological: Pneumovax (PPSV23) Biological: Prevnar (PCV7) Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pneumococcal Vaccine Response in COPD
Study Start Date : March 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Pneumovax (PPSV23)
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
Biological: Pneumovax (PPSV23)
Injection
Other Names:
  • 23-valent pneumococcal capsular polysaccharide vaccine
  • PPSV23
  • 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




Primary Outcome Measures :
  1. Serotype Opsonization Titers [ Time Frame: Measured at Baseline, Months 1, 12, and 24 ]
    Opsonophagocytosis activity (OPK) serotype specific geometric means


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457977


Locations
Show Show 18 study locations
Sponsors and Collaborators
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Study Director: Antonello Punturieri, MD National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00457977    
Other Study ID Numbers: 477
U10HL074424 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2007    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015
Last Verified: April 2015
Keywords provided by University of Minnesota:
Chronic Obstructive Pulmonary Disease
COPD
Pneumococcal
Vaccine
Opsonization
Antibodies
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs