Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease (PNEUMO)
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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 |
- Serotype-specific opsonization titers [ Time Frame: Measured at Months 1, 12, and 24 ] [ Designated as safety issue: No ]
- 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:
|
|
Active Comparator: Prevnar (PCV7)
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
|
Biological: Prevnar (PCV7)
Injection
Other Names:
|
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 |
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| 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 | |
| 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 June 18, 2013