Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial.

Abstract

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.

• Authors: Takaya Maruyama, Osamu Taguchi, Michael S Niederman, John Morser, Hiroyasu Kobayashi, Tetsu Kobayashi, Corina D'Alessandro-Gabazza, Sei Nakayama, Kimiaki Nishikubo, Takashi Noguchi, Yoshiyuki Takei, Esteban C Gabazza
• Journal: BMJ (Clinical research ed.) (BMJ) Vol. 340 Pg. c1004 (Mar 08 2010) ISSN: 1756-1833 [Electronic] England
• PMID: 20211953 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 23-valent pneumococcal capsular polysaccharide vaccine
• Pneumococcal Vaccines

Topics

• Aged
• Aged, 80 and over
• Double-Blind Method
• Homes for the Aged
• Humans
• Institutionalization (statistics & numerical data)
• Japan (epidemiology)
• Kaplan-Meier Estimate
• Middle Aged
• Nursing Homes
• Pneumococcal Vaccines (therapeutic use)
• Pneumonia, Pneumococcal (mortality, prevention & control)
• Treatment Outcome