Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Pneumococcal, Vaccine, Opsonization, Antibodies
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.
Interventions
BIOLOGICALPneumovax (PPSV23)
Injection
BIOLOGICALPrevnar (PCV7)
Injection
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotype Opsonization Titers | Measured at Baseline, Months 1, 12, and 24 | Opsonophagocytosis activity (OPK) serotype specific geometric means |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Recruitment details
Participant's were recruited from 10 medical centers across the US from April 9, 2007 to May 7, 2009.
Participants by arm
| Arm | Count |
|---|---|
| Pneumovax (PPSV23) pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) | 90 |
| Prevnar (PCV7) diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose | 91 |
| Total | 181 |
Baseline characteristics
| Characteristic | Pneumovax (PPSV23) | Total | Prevnar (PCV7) |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 9 | 63 years STANDARD_DEVIATION 9 |
| Current Smoker Current Smoker | 32 participants | 65 participants | 33 participants |
| Current Smoker Non-Current Smoker | 58 participants | 116 participants | 58 participants |
| FEV1 (% Predicted) | 44.8 percent predicted STANDARD_DEVIATION 15.1 | 44.8 percent predicted STANDARD_DEVIATION 14.9 | 44.9 percent predicted STANDARD_DEVIATION 14.7 |
| Forced expiratory volume at one second (FEV1) | 1.27 LIters (L) STANDARD_DEVIATION 0.5 | 1.30 LIters (L) STANDARD_DEVIATION 0.51 | 1.33 LIters (L) STANDARD_DEVIATION 0.53 |
| forced expiratory volume at one second/forced vital capacity (FEV1/FVC) | 45.0 percentage of FEV1/FVC STANDARD_DEVIATION 12.5 | 45.4 percentage of FEV1/FVC STANDARD_DEVIATION 12.5 | 45.8 percentage of FEV1/FVC STANDARD_DEVIATION 12.6 |
| Oxygen use at baseline Non-oxygen user | 61 participants | 131 participants | 70 participants |
| Oxygen use at baseline Oxygen User | 29 participants | 50 participants | 21 participants |
| Pack years smoking | 54.9 pack years STANDARD_DEVIATION 27.1 | 53.4 pack years STANDARD_DEVIATION 27.3 | 52.0 pack years STANDARD_DEVIATION 27.6 |
| Race African American | 18 participants | 36 participants | 18 participants |
| Race Asian | 0 participants | 2 participants | 2 participants |
| Race Caucasian | 68 participants | 138 participants | 70 participants |
| Race More than one | 3 participants | 3 participants | 0 participants |
| Race Native American | 0 participants | 1 participants | 1 participants |
| Race Pacific Islander | 1 participants | 1 participants | 0 participants |
| Region of Enrollment United States | 90 participants | 181 participants | 91 participants |
| Sex: Female, Male Female | 38 Participants | 70 Participants | 32 Participants |
| Sex: Female, Male Male | 52 Participants | 111 Participants | 59 Participants |
| Vaccine Naive Previously Vaccinated | 48 participants | 94 participants | 46 participants |
| Vaccine Naive Vaccine Naive | 42 participants | 87 participants | 45 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 58 / 90 | 54 / 91 |
| serious Total, serious adverse events | 27 / 90 | 32 / 91 |
Outcome results
Primary
Serotype Opsonization Titers
Opsonophagocytosis activity (OPK) serotype specific geometric means
Time frame: Measured at Baseline, Months 1, 12, and 24
Population: All participants with blood samples were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 6B 1-Year | 293.06 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 4 2-Year | 69.12 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 14 2-Year | 594.09 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 6B 2-Year | 240.32 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 18C Baseline | 42.32 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 4 Baseline | 10.85 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 18C 1-Month | 544.49 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 9V Baseline | 37.17 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 18C 1-Year | 284.41 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 6B Baseline | 33.26 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 18C 2-Year | 267.94 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 9V 1-Month | 267.34 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 19F Baseline | 13.71 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 4 1-Year | 61.79 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 19F 1-Month | 266.49 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 9V 1-Year | 142.22 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 19F 1-year | 116.35 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 6B 1-Month | 388.08 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 19F 2-Year | 134.21 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 9V 2-Year | 219.35 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 23F Baseline | 11.79 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 14 Baseline | 138.61 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 23F 1-Month | 114.86 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 4 1-Month | 132.51 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 23F 1-Year | 47.75 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 14 1-Month | 1895.17 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 23F 2-Year | 39.97 titers |
| Pneumovax (PPSV23) | Serotype Opsonization Titers | Serotype 14 1-Year | 839.72 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 23F 2-Year | 266.16 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 9V 2-Year | 432.85 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 4 Baseline | 12.63 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 4 1-Month | 908.23 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 4 1-Year | 268.52 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 4 2-Year | 236.89 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 6B Baseline | 49.76 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 6B 1-Month | 1003.30 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 6B 1-Year | 476.15 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 6B 2-Year | 322.98 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 9V Baseline | 31.44 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 9V 1-Month | 734.52 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 9V 1-Year | 443.55 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 14 Baseline | 116.90 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 14 1-Month | 2584.06 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 14 1-Year | 1801.11 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 14 2-Year | 1255.24 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 18C Baseline | 42.81 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 18C 1-Month | 1815.99 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 18C 1-Year | 665.09 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 18C 2-Year | 540.01 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 19F Baseline | 16.86 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 19F 1-Month | 193.62 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 19F 1-year | 85.87 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 19F 2-Year | 116.40 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 23F Baseline | 18.35 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 23F 1-Month | 1170.32 titers |
| Prevnar (PCV7) | Serotype Opsonization Titers | Serotype 23F 1-Year | 407.11 titers |
Secondary
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)
Time frame: Measured at Baseline, Months 1, 12, and 24
Population: All participants with blood samples were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F Baseline | 3.20 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 1-Month | 0.74 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 1-Year | 0.43 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 2-Year | 0.45 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B Baseline | 0.89 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B 1-Month | 2.26 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B 1-Year | 1.32 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B 2-Year | 1.27 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V Baseline | 0.83 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V 1-Month | 2.72 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V 1-Year | 1.53 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V 2-Year | 1.37 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 Baseline | 2.59 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 1-Month | 10.80 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 1-Year | 5.76 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 2-Year | 4.82 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C Baseline | 1.16 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C 1-Month | 4.25 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C 1-Year | 2.25 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C 2-Year | 1.94 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 Baseline | 0.30 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F 1-Month | 6.79 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F 1-year | 4.25 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F 2-Year | 3.85 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F Baseline | 0.58 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F 1-Month | 1.88 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F 1-Year | 1.12 ug/ml |
| Pneumovax (PPSV23) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F 2-Year | 1.00 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 1-Month | 15.73 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 Baseline | 0.28 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F Baseline | 0.74 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 1-Month | 1.95 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 1-Year | 7.47 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 1-Year | 0.70 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F 1-Month | 7.54 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 4 2-Year | 0.53 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 2-Year | 5.68 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B Baseline | 0.90 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F 1-Year | 2.73 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B 1-Month | 3.19 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C Baseline | 1.07 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B 1-Year | 1.77 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F 1-year | 4.32 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 6B 2-Year | 1.33 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C 1-Month | 9.65 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V Baseline | 0.78 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F 1-Month | 7.76 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V 1-Month | 4.87 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F Baseline | 3.01 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C 1-Year | 3.74 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V 1-Year | 2.15 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 19F 2-Year | 3.68 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 9V 2-Year | 1.65 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 18C 2-Year | 2.77 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 14 Baseline | 2.53 ug/ml |
| Prevnar (PCV7) | Serotype-specific Immunoglobulin G (IgG) Antibody Levels | Serotype 23F 2-Year | 1.99 ug/ml |