Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults
Open accessAbstract
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-to-treat 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. (Funded by Pfizer; CAPITA ClinicalTrials.gov number NCT00744263.).
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The 13-valent conjugate vaccine has clinical efficacy of 45.6% for confirmed vaccine-type community-acquired pneumonia and 75.0% for vaccine-type invasive disease in elderly persons.
“Recently, a 13-valent conjugate vaccine has been licensed for adults and its clinical efficacy was 45.6% (95.2% CI 21.8–62.5, p<0.001) for confirmed vaccine-type community-acquired pneumonia and 75.0% (95% CI 41.4–90.8, p<0.001) for vaccine-type invasive disease in a large randomized placebo-controlled study enrolling more than 84,000 elderly persons [168].”
From Aging of the immune system: Focus on inflammation and vaccination (2016) · cites this paper as [168]
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- Authors
- Bonten, M. J. M., Huijts, S. M., Bolkenbaas, M., Webber, C., Patterson, S., Gault, S., van Werkhoven, C. H., van Deursen, A. M. M., Sanders, E. A. M., Verheij, T. J. M., Patton, M., McDonough, A., Moradoghli-Haftvani, A., Smith, H., Mellelieu, T., Pride, M. W., Crowther, G., Schmoele-Thoma, B., Scott, D. A., Jansen, K. U., Lobatto, R., Oosterman, B., Visser, N., Caspers, E., Smorenburg, A., Emini, E. A., Gruber, W. C., & Grobbee, D. E.
- Affiliations
- University Medical Center Utrecht (NL)
- Pfizer (United States) (US)
- Julius Clinical Research BV (Netherlands) (NL)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-03-19
- Volume
- 372
- Issue
- 12
- Pages
- 1114-1125
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2092545077
- Cited by
- 1,248
- References
- 37
- Citations by year
- 2026: 76 · 2025: 97 · 2024: 82 · 2023: 80 · 2022: 95 · 2021: 109 · 2020: 103 · 2019: 115 · 2018: 123 · 2017: 123 · 2016: 151 · 2015: 92 · 2014: 2
- FWCI
- 127.89
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Epidemiology › Pneumonia and Respiratory Infections
- Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
- Life Sciences › Immunology and Microbiology › Microbiology › Microbial infections and disease research
- Keywords
- PCV13, Streptococcus pneumoniae, invasive pneumococcal disease, older adults, vaccine efficacy, urine antigen detection, vaccine safety, local reactions, serotype-specific antibodies, serotype replacement, serotype 19A
- MeSH terms
- Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Male, Pneumonia, Pneumonia, Pneumococcal, Community-Acquired Infections, Vaccines, Conjugate, Pneumococcal Vaccines
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