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Design and Analysis of Vaccine Studies

Part of the Statistics for Biology and Health Book Series

DOI: 10.1007/978-0-387-68636-3

ISBN: 978-0-387-40313-7

Publisher: Springer New York - Springer Journals

Sep 26, 2009

1 - 10 of 15 Chapters

Available

Introduction and Examples

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 1 –18

[Vaccine efficacy and vaccine effectiveness, VE, are generally estimated as one minus some measure of relative risk, RR, in the vaccinated group compared to the unvaccinated group: 1.1\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts}...
Available

Overview of Vaccine Effects and Study Designs

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 19 –45

[In this chapter, we present a systematic framework showing the relation among many of the different vaccination effects and the parameters and study designs to estimate them. This framework provides a structure for thinking about the different vaccine effects of interest and how they are related...
Available

Immunology and Early Phase Trials

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 47 –62

[The biological basis of successful vaccination is our own complex immune system and its response to pathogens. Vaccination can induce an immune response that mimics natural infection or tries to do even better than our response to a pathogen. Vaccination induces an immune response in the...
Available

Binomial and Stochastic Transmission Models

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 63 –84

[How we think about the transmission dynamics of an infectious agent within a host population influences how we design, analyze, and interpret vaccine studies. It can influence our choice of interventions. In this chapter and the next we introduce transmission models necessary for estimating and...
Available

R0 and Deterministic Models

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 85 –102

[The basic reproductive number, R0, is defined as the expected number of new infectious hosts that one typical infectious host will produce during his or her infectious period in a large, completely susceptible population. For example, if R0 = 5 for mumps in a human population, then one...
Available

Evaluating Protective Effects of Vaccination

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 103 –129

[Evaluating the direct protective effects of vaccines in the individuals who were vaccinated has been the focus of vaccine studies over the past century. Generally, interest has been in the ability of vaccination to prevent or to ameliorate disease rather than to prevent infection (Clements-Mann...
Available

Modes of Action and Time-Varying VES

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 131 –151

[Suppose you have just been vaccinated against an infectious agent. Your physician or health practitioner tells you that the protective efficacy of the vaccine is 90%. You might then wonder if that means that the vaccine reduces your probability of contracting the infection (or disease) by 0.90...
Available

Further Evaluation of Protective Effects

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 153 –175

[Case-control studies can be used to estimate the relative risk measures in VES,CI and VES,IR (VES,λ ). In a case-control study, cases of the disease are ascertained, and information on various covariates collected. A covariate of particular interest here is vaccination status. Then controls are...
Available

Vaccine Effects on Post-Infection Outcomes

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 177 –203

[A common question of interest is whether clinical cases in infected vaccinated people are less severe than clinical cases in infected unvaccinated people. As early as 1939, Kendrick and Eldering described less severe disease in children with pertussis who had been inoculated with pertussis...
Available

Household-Based Studies

Halloran, M. Elizabeth; Longini, Ira M.; Struchiner, Claudio J.

Pages: 205 –234

[In Chapter 2 we introduced vaccine efficacy parameters that require conditioning on exposure to infection. Household studies were used as the basis for defining exposure to infection in vaccine studies as early as the 1930s in evaluating the efficacy of pertussis vaccines (Kendrick and Eldering...

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