Clinical trial NCT00457977: Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease
Official title: Pneumococcal Vaccine Response in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Pneumococcal
Vaccine
Opsonization
Antibodies
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-04-09
Enrollment: 181
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Serotype Opsonization Titers
timeFrame: Measured at Baseline, Months 1, 12, and 24
Secondary outcomes:
measure: Serotype-specific Immunoglobulin G (IgG) Antibody Levels
timeFrame: Measured at Baseline, Months 1, 12, and 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Veteran's Administration Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: LA BioMed at Harbor, University of California
state: California
city: San Francisco
country: United States
facility: University of California San Francisco-Airway Clinical Research Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Denver
country: United States
facility: Veteran's Administration Medical Center
state: Colorado
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: Boston
country: United States
facility: Fallon Clinic
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Veteran's Administration Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Veteran's Administration Medical Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Veteran's Administration Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: HealthPartners Research Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Temple University Lung Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Emphysema Research Center
state: Pennsylvania
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Antonello Punturieri, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.