Pulmonary Disease, Chronic ObstructivePhase 3PNEUMONCT00457977
Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Pneumovax (PPSV23) and Prevnar (PCV7) in people with Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Pneumovax (PPSV23) and Prevnar (PCV7)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2007to May 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Veteran's Administration Medical Center
Ann Arbor, Michigan, 48105
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0360
University of Maryland Hospital
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Veteran's Administration Medical Center
Birmingham, Alabama, 35294-0006
Fallon Clinic
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02132
Veteran's Administration Medical Center
Boston, Massachusetts, 02132
Denver Health Medical Center
Denver, Colorado, 80204-4507
National Jewish Medical and Research Center
Denver, Colorado, 80204-4507
Veteran's Administration Medical Center
Denver, Colorado, 80220
LA BioMed at Harbor, University of California
Los Angeles, California, 90502
Veteran's Administration Medical Center
Minneapolis, Minnesota, 55417
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440
Temple University Lung Center
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Emphysema Research Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco-Airway Clinical Research Center
San Francisco, California, 94143
About this study
Official title: Pneumococcal Vaccine Response in COPD
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Pneumovax (PPSV23), Prevnar (PCV7)
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Pneumococcal, Vaccine, Opsonization, Antibodies
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumovax (PPSV23)Biological
Also called 23-valent pneumococcal capsular polysaccharide vaccine, PPSV23, Pneumovax
Injection
Prevnar (PCV7)Biological
Also called 7-valent pneumococcal conjugate vaccine, PCV7, Prevnar
Injection
| Study group | Role | What they receive |
|---|---|---|
| Pneumovax (PPSV23) | Active comparator | pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) Receives: Biological: Pneumovax (PPSV23) |
| Prevnar (PCV7) | Active comparator | diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose Receives: Biological: Prevnar (PCV7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotype Opsonization Titers
Opsonophagocytosis activity (OPK) serotype specific geometric means
Measured: Measured at Baseline, Months 1, 12, and 24
Secondary outcomes (1)
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)
Measured: Measured at Baseline, Months 1, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Antonello Punturieri, MD, Study director, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457977
- Sponsor's protocol ID
- 477
- Other IDs
- U10HL074424
- Acronym
- PNEUMO
- Status last verified
- Apr 2015
- First submitted
- 5 Apr 2007
- Last updated
- 12 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dransfield MT, Harnden S, Burton RL, Albert RK, Bailey WC, Casaburi R, Connett J, Cooper JA, Criner GJ, Curtis JL, Han MK, Make B, Marchetti N, Martinez FJ, McEvoy C, Nahm MH, Niewoehner DE, Porszasz J, Reilly J, Scanlon PD, Scharf SM, Sciurba FC, Washko GR, Woodruff PG, Lazarus SC; NIH COPD Clinical Research Network. Long-term comparative immunogenicity of protein conjugate and free polysaccharide pneumococcal vaccines in chronic obstructive pulmonary disease. Clin Infect Dis. 2012 Sep;55(5):e35-44. doi: 10.1093/cid/cis513. Epub 2012 May 31.
PubMed 22652582Dransfield MT, Nahm MH, Han MK, Harnden S, Criner GJ, Martinez FJ, Scanlon PD, Woodruff PG, Washko GR, Connett JE, Anthonisen NR, Bailey WC; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Sep 15;180(6):499-505. doi: 10.1164/rccm.200903-0488OC. Epub 2009 Jun 25.
PubMed 19556517
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumococcal Vaccine Response in COPD
- ClinicalTrials.gov ID
- NCT00457977
- Acronym / sponsor ID
- PNEUMO / 477
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Pneumococcal, Vaccine, Opsonization, Antibodies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Apr 2007 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumovax (PPSV23) | Active comparator | Biological: Pneumovax (PPSV23)pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax) |
| Prevnar (PCV7) | Active comparator | Biological: Prevnar (PCV7)diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumovax (PPSV23)Also: 23-valent pneumococcal capsular polysaccharide vaccine, PPSV23, PneumovaxInjection | Biological | Pneumovax (PPSV23) |
| Prevnar (PCV7)Also: 7-valent pneumococcal conjugate vaccine, PCV7, PrevnarInjection | Biological | Prevnar (PCV7) |
Primary outcome
Serotype Opsonization Titers
Time frame: Measured at Baseline, Months 1, 12, and 24
Opsonophagocytosis activity (OPK) serotype specific geometric means
1 secondary outcome
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Time frame: Measured at Baseline, Months 1, 12, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22652582Dransfield MT, Harnden S, Burton RL, Albert RK, Bailey WC, Casaburi R, Connett J, Cooper JA, Criner GJ, Curtis JL, Han MK, Make B, Marchetti N, Martinez FJ, McEvoy C, Nahm MH, Niewoehner DE, Porszasz J, Reilly J, Scanlon PD, Scharf SM, Sciurba FC, Washko GR, Woodruff PG, Lazarus SC; NIH COPD Clinical Research Network. Long-term comparative immunogenicity of protein conjugate and free polysaccharide pneumococcal vaccines in chronic obstructive pulmonary disease. Clin Infect Dis. 2012 Sep;55(5):e35-44. doi: 10.1093/cid/cis513. Epub 2012 May 31.
- Derived from this study: PubMed 19556517Dransfield MT, Nahm MH, Han MK, Harnden S, Criner GJ, Martinez FJ, Scanlon PD, Woodruff PG, Washko GR, Connett JE, Anthonisen NR, Bailey WC; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Sep 15;180(6):499-505. doi: 10.1164/rccm.200903-0488OC. Epub 2009 Jun 25.
- Click here for the National Institutes of Health Web site.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonello Punturieri, MD study director
National Heart, Lung, and Blood Institute (NHLBI)
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pneumovax (PPSV23) and Prevnar (PCV7) in people with Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotype Opsonization Titers (time frame: Measured at Baseline, Months 1, 12, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457977, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.