Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trialBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1004 (Published 08 March 2010) Cite this as: BMJ 2010;340:c1004
- Takaya Maruyama, resident physician and researcher1,
- Osamu Taguchi, associate professor and vice chairman1,
- Michael S Niederman, professor of medicine and chairman6,
- John Morser, senior research scientist5,
- Hiroyasu Kobayashi, assistant professor and chief resident1,
- Tetsu Kobayashi, assistant professor1,
- Corina D’Alessandro-Gabazza, research assistant1,
- Sei Nakayama, resident physician4,
- Kimiaki Nishikubo, resident physician4,
- Takashi Noguchi, director4,
- Yoshiyuki Takei, professor and chairman2,
- Esteban C Gabazza, professor and chairman3
- 1Department of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Japan
- 2Department of Gastroenterology and Hepatology, Mie University Graduate School of Medicine, Japan
- 3Department of Immunology, Mie University Graduate School of Medicine, Edobashi 2-174, Tsu City, Mie Prefecture, Japan
- 4Kinan General Hospital, Minamimuro, Mie, Japan
- 5Division of Hematology, Stanford School of Medicine, Stanford, CA, USA
- 6Department of Medicine, Winthrop University Hospital, Mineola, NY, USA
- Correspondence to: E C Gabazza
- Accepted 27 December 2009
Objective To determine the efficacy of a 23-valent pneumococcal polysaccharide vaccine in people at high risk of pneumococcal pneumonia.
Design Prospective, randomised, placebo controlled double blind study.
Setting Nursing homes in Japan.
Participants 1006 nursing home residents.
Interventions Participants were randomly allocated to either 23-valent pneumococcal polysaccharide vaccine (n=502) or placebo (n=504).
Main outcome measures The primary end points were the incidence of all cause pneumonia and pneumococcal pneumonia. Secondary end points were deaths from pneumococcal pneumonia, all cause pneumonia, and other causes.
Results Pneumonia occurred in 63 (12.5%) participants in the vaccine group and 104 (20.6%) in the placebo group. Pneumococcal pneumonia was diagnosed in 14 (2.8%) participants in the vaccine group and 37 (7.3%) in the placebo group (P<0.001). All cause pneumonia and pneumococcal pneumonia were significantly more frequent in the placebo group than in the vaccine group: incidence per 1000 person years 55 v 91 (P<0.0006) and 12 v 32 (P<0.001), respectively. Death from pneumococcal pneumonia was significantly higher in the placebo group than in the vaccine group (35.1% (13/37) v 0% (0/14), P<0.01). The death rate from all cause pneumonia (vaccine group 20.6% (13/63) v placebo group 25.0% (26/104), P=0.5) and from other causes (vaccine group 17.7% (89/502) v placebo group (80/504) 15.9%, P=0.4) did not differ between the two study groups.
Conclusion The 23-valent pneumococcal polysaccharide vaccine prevented pneumococcal pneumonia and reduced mortality from pneumococcal pneumonia in nursing home residents.
Trial registration Japan Medical Association Center for Clinical Trials JMA-IIA00024.
We thank Hirokazu Toyoshima, Tomu Nakagawa, Takashi Kitade, Minori Itou, Tsutomu Sekoguchi, Naoyuki Nakase, Hiroshi Wada, Takashi Matsumoto, Suzue Kinoshita, Miho kijima, Chisato Yamamoto Kiichi Hine, Yoshiaki Nagai, Hideyo Yamamoto, Kyoko Nishida, Hiroko Uemoto, Mie Nakamura, Ikuyo Shiroyama, Mikako Matsuda, Yumi Shimizu, Fujiko Onishi, Keiko Sugioka, Emiko Funahashi, Takae Nishi, Shigeyo Hiraga, Kazuko Nakamura, Mariko Imai, Setsuko Takagaido, Kazumi Nakagawa, and Minako Hagino.
Contributors: TM, OT, and ECG designed the study. TM and HK coordinated the conduct of the study. CD’A-G collected the samples and data. TK, SK, KN, SN, KN, and TN coordinated the recruitment of participants and collection of samples. YT, OT, ECG, JM, and MSN interpreted the findings. TM, ECG, and JM drafted the paper. TM and ECG are the guarantors.
Funding: This study was funded by a grant in aid from the Ministry of Education, Culture, Sports, Science and Technology of Japan. The funder had no role in study design, data collection, data analysis, data interpretation, or writing of the manuscript. TM and ECG had full access to all the data and had final responsibility for the decision to publish the paper.
Competing interests: None declared.
Ethical approval: This study was approved by the ethical committee at each participating institution.
Data sharing: No additional data available.
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