Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease
PNEUMO
Pneumococcal Vaccine Response in COPD
2 other identifiers
interventional
181
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2007
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 5, 2007
CompletedFirst Posted
Study publicly available on registry
April 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
May 12, 2015
CompletedMay 12, 2015
April 1, 2015
4.2 years
April 5, 2007
March 27, 2014
April 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serotype Opsonization Titers
Opsonophagocytosis activity (OPK) serotype specific geometric means
Measured at Baseline, Months 1, 12, and 24
Secondary Outcomes (1)
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Measured at Baseline, Months 1, 12, and 24
Study Arms (2)
Pneumovax (PPSV23)
ACTIVE COMPARATORpneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
Prevnar (PCV7)
ACTIVE COMPARATORdiphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
Interventions
Injection
Injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Veteran's Administration Medical Center
Birmingham, Alabama, 35294-0006, United States
LA BioMed at Harbor, University of California
Los Angeles, California, 90502, United States
University of California San Francisco-Airway Clinical Research Center
San Francisco, California, 94143, United States
Denver Health Medical Center
Denver, Colorado, 80204-4507, United States
National Jewish Medical and Research Center
Denver, Colorado, 80204-4507, United States
Veteran's Administration Medical Center
Denver, Colorado, 80220, United States
University of Maryland Hospital
Baltimore, Maryland, 21201, United States
Fallon Clinic
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02132, United States
Veteran's Administration Medical Center
Boston, Massachusetts, 02132, United States
Veteran's Administration Medical Center
Ann Arbor, Michigan, 48105, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0360, United States
Veteran's Administration Medical Center
Minneapolis, Minnesota, 55417, United States
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Temple University Lung Center
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Emphysema Research Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (2)
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.
PMID: 22652582DERIVEDDransfield 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.
PMID: 19556517DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sarah Harnden
- Organization
- University of Minnesota
Study Officials
- STUDY DIRECTOR
Antonello Punturieri, MD
National Heart, Lung, and Blood Institute (NHLBI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2007
First Posted
April 9, 2007
Study Start
March 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 12, 2015
Results First Posted
May 12, 2015
Record last verified: 2015-04