Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00457977
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2014-03-27
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-22
• Last Update Submitted: 2015-04-22
• Results First Posted: 2015-05-12
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serotype Opsonization Titers	Measured at Baseline, Months 1, 12, and 24	Opsonophagocytosis activity (OPK) serotype specific geometric means

Secondary Outcome Measures

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

Trial Locations

Locations (14)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Veteran's Administration Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

LA BioMed at Harbor, University of California; 🇺🇸 Los Angeles, California, United States

University of California San Francisco-Airway Clinical Research Center; 🇺🇸 San Francisco, California, United States

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States

National Jewish Medical and Research Center; 🇺🇸 Denver, Colorado, United States

University of Maryland Hospital; 🇺🇸 Baltimore, Maryland, United States

Fallon Clinic; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

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