Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00457977

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-05-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pneumovax (PPSV23)

pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)

Group Type: ACTIVE_COMPARATOR

Pneumovax (PPSV23)

Intervention Type: BIOLOGICAL

Injection

Prevnar (PCV7)

diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose

Group Type: ACTIVE_COMPARATOR

Prevnar (PCV7)

Intervention Type: BIOLOGICAL

Injection

Interventions

Pneumovax (PPSV23)

Injection

Intervention Type: BIOLOGICAL

Prevnar (PCV7)

Injection

Intervention Type: BIOLOGICAL

Other Intervention Names

23-valent pneumococcal capsular polysaccharide vaccine; PPSV23; Pneumovax; 7-valent pneumococcal conjugate vaccine; PCV7; Prevnar

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonello Punturieri, MD

Role: STUDY_DIRECTOR

National Heart, Lung, and Blood Institute (NHLBI)

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Veteran's Administration Medical Center

Birmingham, Alabama, United States

LA BioMed at Harbor, University of California

Los Angeles, California, United States

University of California San Francisco-Airway Clinical Research Center

San Francisco, California, 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

University of Maryland Hospital

Baltimore, Maryland, United States

Fallon Clinic

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Veteran's Administration Medical Center

Boston, Massachusetts, United States

Veteran's Administration Medical Center

Ann Arbor, Michigan, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Veteran's Administration Medical Center

Minneapolis, Minnesota, United States

HealthPartners Research Foundation

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Temple University Lung Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Emphysema Research Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22652582 (View on PubMed)

Dransfield 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.

Reference Type: DERIVED

PMID: 19556517 (View on PubMed)

Related Links

http://www.nih.gov/

Click here for the National Institutes of Health Web site.

Other Identifiers

U10HL074424

Identifier Type: NIH

Identifier Source: secondary_id

View Link

477

Identifier Type: -

Identifier Source: org_study_id