Free Content Epidemiological studies of the `non-specific effects' of vaccines: I - data collection in observational studies

Authors: Fine, Paul E. M.1; Williams, Thomas N.; Aaby, Peter; Källander, Karin; Moulton, Lawrence H.2; Flanagan, Katie L.3; Smith, Peter G.1; Benn, Christine S.

Source: Tropical Medicine & International Health, Volume 14, Number 9, September 2009 , pp. 969-976(8)

Publisher: Wiley-Blackwell

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Abstract:

Summary

Routine vaccination programmes have led to substantial declines in the incidence of most of the target diseases. In these circumstances, vaccine effects beyond those on the target diseases may become evident. Several studies have suggested that certain vaccines may influence mortality in low income settings in ways that cannot be attributed to effects on target diseases. Trials of such `non-specific' effects are difficult if not impossible to organise; and observational studies of them are prone to serious confounding, because those who do or do not receive vaccines are likely to differ in many ways, some of which relate to their subsequent risk of early death, independent of vaccination. They are also prone to other biases, including the selective loss of vaccination records for children who die. We review these potential sources of bias and suggest what and how data may be collected to optimise the validity of such studies.

French
Les programmes de vaccination de routine ont conduit à d'importantes baisses de l'incidence de la plupart des maladies cibles. Dans ces circonstances, les effets du vaccin en dehors de ceux sur les maladies cibles peuvent devenir évidents. Plusieurs études ont suggéré que certains vaccins peuvent influencer la mortalité dans les régions à faibles revenus, par des moyens qui ne peuvent être attribués aux effets sur les maladies cibles. Les investigations de ces effets «non-spécifiques” sont difficiles, voire impossibles à concevoir et les études d'observation sur ces effets sont sujettes à de sérieux variables confusionnels car ceux qui reçoivent ou non les vaccins sont susceptibles de varier de diverses manières, dont certaines se rapportent à leur risque de décès prématuré, indépendamment de la vaccination. Elles sont également sujettes à d'autres biais, y compris la perte sélective des registres de vaccination pour les enfants qui décèdent. Nous passons ici en revue ces sources potentielles de biais et suggérons qu'elles données et de quelle manière elles devraient être collectées afin d'optimiser la validité de ces études.

Keywords: vaccines; mortality; non-specific effects; study design; vaccins; mortalité; effets non spécifiques; conception d'étude; Vacunas; mortalidad; efectos no específicos; diseño de estudio

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-3156.2009.02301.x

Affiliations: 1:  London School of Hygiene & Tropical Medicine, London, UK 2:  Department of International Health, Johns Hopkins University, Baltimore, MD, USA 3:  Medical Research Council Laboratories, Fajara, The Gambia

Publication date: 2009-09-01

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