Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

— PNEUMO  

Official title:

Pneumococcal Vaccine Response in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457977
• Other study ID #: 477
• Secondary ID: U10HL074424
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2007
• Last updated: April 22, 2015
• Start date: March 2007
• Est. completion date: May 2011

Study information

• Verified date: April 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• Pneumovax (PPSV23)
Injection
• Prevnar (PCV7)
Injection

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Veteran's Administration Medical Center	Ann Arbor	Michigan
United States	University of Maryland Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Veteran's Administration Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Fallon Clinic	Boston	Massachusetts
United States	Veteran's Administration Medical Center	Boston	Massachusetts
United States	Denver Health Medical Center	Denver	Colorado
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Veteran's Administration Medical Center	Denver	Colorado
United States	LA BioMed at Harbor, University of California	Los Angeles	California
United States	HealthPartners Research Foundation	Minneapolis	Minnesota
United States	Veteran's Administration Medical Center	Minneapolis	Minnesota
United States	Temple University Lung Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Emphysema Research Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Francisco-Airway Clinical Research Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotype Opsonization Titers	Opsonophagocytosis activity (OPK) serotype specific geometric means	Measured at Baseline, Months 1, 12, and 24	No
Secondary	Serotype-specific Immunoglobulin G (IgG) Antibody Levels	Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)	Measured at Baseline, Months 1, 12, and 24	No

External Links

•   Click here for the National Institutes of Health Web site.