Clinical Efficacy of Pneumococcal Vaccine in the Elderly: A Randomized, Single-Blind Population-Based Trial

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Abstract

PURPOSE: To study the efficacy of pneumococcal capsular polysaccharide vaccine among the elderly by use of a population-based intervention in one township, Varkaus, Eastern Finland.

PATIENTS AND METHODS: A randomized, controlled trial in which elderly inhabitants (aged 60 years or older) of the catchment area were randomized to receive either pneumococcal and influenza vaccines (PI group = vaccinated) or influenza vaccine alone (I group = controls) and offered participation. The response rate was 67.4%. The PI group consisted of 1,364 persons and the I group of 1,473 persons. The vaccinations were performed in the municipal health center in the fall of 1982, and all elderly inhabitants were followed for 3 years for the development of radiologically confirmed pneumonia. Pneumococcal etiology was identified by serological methods.

RESULTS: The incidence of pneumonia was 18.8 per 1,000 person-years in the PI group (73 pneumonia episodes) and 16.6 per 1,000 person-years in the I group (69 episodes). Pneumococcal etiology was found in 27 episodes in the PI group (incidence 7.0 per 1,000 person-years) and in 36 episodes in the I group (incidence 8.6 per 1,000 person-years). In controls (I group) the incidence of pneumococcal pneumonia was significantly higher among persons with increased risk for contracting pneumonia (19 per 1,000 person-years) than among controls with low risk status (4 per 1,000 person-years). No significant protection from pneumococcal pneumonia was found in the study group as a whole (vaccine efficacy 15%, 95% CI −43% to 50%). However, in persons with medical risk factors for contracting pneumonia, there was a statistically significant protective efficacy of 59% (95% CI, 6% to 82%).

CONCLUSION: Pneumococcal vaccination significantly reduced the incidence of pneumococcal pneumonia in elderly persons at increased risk for contracting pneumonia. This increased/high-risk category comprised 34% of the population aged 60 years or older. Because targeted vaccination of this large group may be difficult to organize in an efficient manner, vaccinating all elderly persons may be the best strategy to prevent this rather common and often fatal disease.

Section snippets

Study Population

The study was conducted among the total elderly population of a small town, Varkaus, which also had participated in the pneumonia incidence study in the previous year, 1981 to 1982.[2]The population of the town was 24,716, of whom 17% were 60 years of age or older. Health care is provided by a municipal health center and a municipal district hospital. Private health care services are available at two practices. The study was approved by the Health Authorities of Varkaus and by the Ethics

Results

A total of 4,213 elderly inhabitants of Varkaus were randomized in either vaccination group and invited to participate to the study. A total of 2,837 inhabitants (67.4%) responded to the invitation letter; 1,364 of these received, according to the randomization, both pneumococcal and influenza vaccine (PI group = vaccinees) and 1,473 received influenza vaccine alone (I group = controls). Of the respondents, 47% were 70 years old or older; 37% were male; and 65% were classified in the low-risk

Discussion

This prospective, randomized trial was conducted among the total elderly population living in a defined geographic area. It showed that the 14-valent pneumococcal vaccine was 59% protective against pneumococcal pneumonia in a large segment of the population: elderly persons with increased risk for pneumonia (Table 3). This subgroup formed 34% of the total elderly population. The vaccination groups were similar with respect to comorbid illnesses, indicating successful randomization. This is very

Acknowledgements

We thank Professor Markku Laakso for advice with statistical methods; Dr Camilla Jokinen for help and advice during all stages of the work; Pirjo-Riitta Rönnberg, the study nurse, for her essential role in collecting data and samples; Dr Reijo Pyhälä for information concerning influenza epidemics during our study; and Dr Juhani Eskola and Dr Esa Läärä for their critical reading of the manuscript.

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    This work was supported by the Paulo Foundation, the Päivikki and Sakari Sohlberg Foundation, the Tampere Tuberculosis Foundation, the Väinö and Laina Kivi Foundation and the Orion Corporation Research Foundation. There is no conflict of interest.

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