Design and analysis of vaccine studies

Widespread immunization has many different kinds of effects in individuals and populations, including in the unvaccinated individuals. The challenge is in understanding and estimating all of these effects. This book presents a unified conceptual framework of the different effects of vaccination at the individual and at the population level. The book covers many different vaccine effects, including vaccine efficacy for susceptibility, for disease, for post-infection outcomes, and for infectiousness. The book includes methods for evaluating indirect, total and overall effects of vaccination programs in populations. Topics include household studies, evaluating correlates of immune protection, and applications of casual inference. Material on concepts of infectious disease epidemiology, transmission models, casual inference, and vaccines provides background for the reader. This is the first book to present vaccine evaluation in this comprehensive conceptual framework.^ This book is intended for colleagues and students in statistics, biostatistics, epidemiology, and infectious diseases. Most essential concepts are described in simple language accessible to epidemiologists, followed by technical material accessible to statisticians. M. Elizabeth Halloran and Ira Longini are professors of biostatistics at the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle. Claudio Struchiner is professor of epidemiology and biostatistics at the Brazilian School of Public Health of the Oswaldo Cruz Foundation in Rio de Janeiro. The authors are prominent researchers in the area. Halloran and Struchiner developed the study designs for dependent happenings to delineate indirect, total, and overall effects. Halloran has made contributions at the interface of epidemiological methods, causal inference, and transmission dynamics.^ Longini works in the area of stochastic processes applied to epidemiological infectious disease problems, specializing in the mathematical and statistical theory of epidemics. Struchiner has contributed to understanding the role of transmission in interpreting vaccine effects.