UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

Methodological challenges in measuring vaccine effectiveness using population cohorts in low resource settings

King, C; Beard, J; Crampin, AC; Costello, A; Mwansambo, C; Cunliffe, NA; Heyderman, RS; ... VacSurv Consortium; + view all (2015) Methodological challenges in measuring vaccine effectiveness using population cohorts in low resource settings. Vaccine , 33 (38) pp. 4748-4755. 10.1016/j.vaccine.2015.07.062. Green open access

[thumbnail of Methodological challenges in measuring vaccine effectiveness using population cohorts in low resource settings.pdf]
Preview
Text
Methodological challenges in measuring vaccine effectiveness using population cohorts in low resource settings.pdf - Published Version

Download (868kB) | Preview

Abstract

Post-licensure real world evaluation of vaccine implementation is important for establishing evidence of vaccine effectiveness (VE) and programme impact, including indirect effects. Large cohort studies offer an important epidemiological approach for evaluating VE, but have inherent methodological challenges. Since March 2012, we have conducted an open prospective cohort study in two sites in rural Malawi to evaluate the post-introduction effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13) against all-cause post-neonatal infant mortality and monovalent rotavirus vaccine (RV1) against diarrhoea-related post-neonatal infant mortality. Our study sites cover a population of 500,000, with a baseline post-neonatal infant mortality of 25 per 1000 live births. We conducted a methodological review of cohort studies for vaccine effectiveness in a developing country setting, applied to our study context. Based on published literature, we outline key considerations when defining the denominator (study population), exposure (vaccination status) and outcome ascertainment (mortality and cause of death) of such studies. We assess various definitions in these three domains, in terms of their impact on power, effect size and potential biases and their direction, using our cohort study for illustration. Based on this iterative process, we discuss the pros and cons of our final per-protocol analysis plan. Since no single set of definitions or analytical approach accounts for all possible biases, we propose sensitivity analyses to interrogate our assumptions and methodological decisions. In the poorest regions of the world where routine vital birth and death surveillance are frequently unavailable and the burden of disease and death is greatest We conclude that provided the balance between definitions and their overall assumed impact on estimated VE are acknowledged, such large scale real-world cohort studies can provide crucial information to policymakers by providing robust and compelling evidence of total benefits of newly introduced vaccines on reducing child mortality.

Type: Article
Title: Methodological challenges in measuring vaccine effectiveness using population cohorts in low resource settings
Location: Netherlands
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.vaccine.2015.07.062
Publisher version: http://dx.doi.org/10.1016/j.vaccine.2015.07.062
Language: English
Additional information: © 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Children, Cohort, Diarrhoea, Methodology, PCV13, Pneumococcal disease, Pneumonia, RV1, Survival analysis, Vaccine effectiveness
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > VP: Research
URI: https://discovery.ucl.ac.uk/id/eprint/1477631
Downloads since deposit
133Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item