Long-term Comparative Immunogenicity of Protein Conjugate and Free Polysaccharide Pneumococcal Vaccines in Chronic Obstructive Pulmonary Disease
Year: 2012
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Although the 23-valent pneumococcal polysaccharide vaccine (PPSV23) protects against invasive disease in young healthy persons, randomized controlled trials in chronic obstructive pulmonary disease (COPD) have demonstrated no benefit in the intention-to-treat population. We previously reported that the 7-valent diphtheria-conjugated pneumococcal polysaccharide vaccine (PCV7) is safe and induced greater serotype-specific immunoglobulin G (IgG) and functional antibody than did PPSV23 1 month after vaccination. We hypothesized that these advantages would persist at 1 and 2 years. METHODS: One hundred eighty-one patients with moderate to severe COPD were randomized to receive PPSV23 (n = 90) or PCV7 (1.0 mL; n = 91). We measured IgG by enzyme-linked immunosorbent assay and assessed functional antibody activity by a standardized opsonophagocytosis assay, reported as a killing index (OPK). We determined differences in IgG and OPK between vaccine groups at 1 and 2 years. RESULTS: Relative to PPSV23, PCV7 induced greater OPK at both 1 and 2 years for 6 of 7 serotypes (not 19F). This response was statistically greater for 5 of 7 serotypes at 1 year and 4 of 7 at 2 years. Comparable differences in IgG were observed but were less often statistically significant. Despite meeting Centers for Disease Control and Prevention criteria for PPSV23 administration, almost 50% of individuals had never been vaccinated. No differences in the frequency of acute exacerbations, pneumonia, or hospitalization were observed. CONCLUSIONS: PCV7 induces a greater functional antibody response than PPSV23 in patients with COPD that persists for 2 years after vaccination. This superior functional response supports testing of conjugate vaccination in studies examining clinical end points. CLINICAL TRIALS REGISTRATION: NCT00457977.
Source: Clinical Infectious Diseases
DOI: 10.1093/cid/cis513
Authors: Mark T. Dransfield, Sarah Harnden, Robert L. Burton, Richard K. Albert, William C. Bailey, Richard Casaburi, John Connett, J. Allen D. Cooper, Gerard J. Criner, Jeffrey L. Curtis, MeiLan K. Han, Barry Make, Nathaniel Marchetti, Fernando J. Martinez, Charlene McEvoy, Moon H. Nahm, Dennis E. Niewoehner, Janos Porszasz, John Reilly, Paul D. Scanlon, Steven M. Scharf, Frank C. Sciurba, George R. Washko, Prescott G. Woodruff, Stephen C. Lazarus
Institutions: University of Alabama at Birmingham, Birmingham VA Medical Center, UAB Medicine, University of Minnesota, Denver Health Medical Center, Harbor–UCLA Medical Center, Temple University, University of Michigan, Michigan Medicine, National Jewish Health, University of Colorado Denver, Minneapolis VA Health Care System, Minneapolis VA Medical Center, University of Pittsburgh, Mayo Clinic, University of Maryland, Baltimore, Brigham and Women's Hospital, University of California, San Francisco
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G101757908, UAB/BVAMC Clinical Center in COPD, Strategies to Improve COPD Management, G1840998190, COPD Clinical Research Network, G2393016743, G310026855, G3267981878, UCLA Clinical and Translational Science Institute, G3316890418, COPD Clinical Research Network - Data Coordinating Center, General Clinical Research Center, G3400784651, General Clinical Research Center, Strategies to Prevent COPD Exacerbation, General Clinical Research Center, G3608845658, G3696205570, General Clinical Research Center, G4421901568, Drug therapy for preventing COPD exacerbations, Novel Strategies Targeting Acute Exacerbation of COPD, G5755355501, G6176523275, G6377884426, G6651018489, COPD Clinical Research Network, General Clinical Research Center, Clinical Center-COPD Clinical Research Network, G804289606, COPD Exacerbations: Pharmacogenetic Approaches to Therapy, G8557107427, COPD Clinical Research Network & Clinical Research Skills Core Development
OpenAlex ID: W2123476108