Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults

M. J M Bonten*, S. M. Huijts, M. Bolkenbaas, C. Webber, S. Patterson, S. Gault, C. H. Van Werkhoven, A. M M Van Deursen, E. A M Sanders, T. J M Verheij, M. Patton, A. McDonough, A. Moradoghli-Haftvani, H. Smith, T. Mellelieu, M. W. Pride, G. Crowther, B. Schmoele-Thoma, D. A. Scott, K. U. JansenR. Lobatto, B. Oosterman, N. Visser, E. Caspers, A. Smorenburg, E. A. Emini, W. C. Gruber, D. E. Grobbee

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BACKGROUND

Pneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown.

METHODS

In a randomized, double-blind, placebo-controlled trial involving 84,496 adults 65 years of age or older, we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine (PCV13) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia, nonbacteremic and noninvasive pneumococcal community-acquired pneumonia, and invasive pneumococcal disease. Standard laboratory methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease.

RESULTS

In the per-protocol analysis of first episodes of infections due to vaccine-type strains, community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group (vaccine efficacy, 45.6%; 95.2% confidence interval [CI], 21.8 to 62.5), nonbacteremic and noninvasive community-acquired pneumonia occurred in 33 persons in the PCV13 group and 60 persons in the placebo group (vaccine efficacy, 45.0%; 95.2% CI, 14.2 to 65.3), and invasive pneumococcal disease occurred in 7 persons in the PCV13 group and 28 persons in the placebo group (vaccine efficacy, 75.0%; 95% CI, 41.4 to 90.8). Efficacy persisted throughout the trial (mean follow-up, 3.97 years). In the modified intention-totreat analysis, similar efficacy was observed (vaccine efficacy, 37.7%, 41.1%, and 75.8%, respectively), and community-acquired pneumonia occurred in 747 persons in the PCV13 group and 787 persons in placebo group (vaccine efficacy, 5.1%; 95% CI, -5.1 to 14.2). Numbers of serious adverse events and deaths were similar in the two groups, but there were more local reactions in the PCV13 group.

CONCLUSIONS

Among older adults, PCV13 was effective in preventing vaccine-type pneumococcal, bacteremic, and nonbacteremic community-acquired pneumonia and vaccine-type invasive pneumococcal disease but not in preventing community-acquired pneumonia from any cause.

Original languageEnglish
Pages (from-to)1114-1125
Number of pages12
JournalNew England Journal of Medicine
Volume372
Issue number12
DOIs
Publication statusPublished - 1 Jan 2015

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