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British Medical Bulletin 44:679-690 (1988)
© 1988 The British Council


research-article

Epidemiological methods to evaluate vaccine efficacy

P G Smith

Tropical Epidemiological Unit, London School of Hygiene and Tropical Medicine London

Abstract

The proper way to measure the protective efficacy of a new vaccine is in a randomised controlled trial. About 10 such trials have been conducted to assess the protection that BCG confers against tuberculosis and four to assess the protective efficacy of this vaccine against leprosy. For both diseases, great variations in efficacy have been observed in different parts of the world. Because of this variation there is a need for evaluation methods which can be used by disease control programmes to estimate vaccine efficacy locally at a national or regional level. In these circumstances, randomised controlled trials are usually ruled out on grounds of both cost and the time that such studies take to complete. Alternative methods, which are both quicker and cheaper, are required. It is suggested that case-control studies provide an acceptable, though methodologically inferior, approach to estimate vaccine efficacy. Some of the strengths and weaknesses of this approach are discussed and guidelines are outlined for the conduct of such studies.


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