[转移贴]2010年新书：Statistics in Clinical Vaccine Trials

cao1976

原贴由wwwkkk83 发表于 2010-10-14 13:03

书名：Statistics in Clinical Vaccine Trials
作者 Jozef Nauta
出版社：   Springer
页码:   160
出版日期:   2010-11-29
  简介
This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

部分目录：
1 Basic Concepts of Vaccine Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Vaccination and Preventing Infectious Diseases . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Microorganisms: Bacteria, Yeasts, Protozoa and Viruses . . . . . . . . . . . . . . . 2
1.3 The Immune System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.1 Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.2 Microbial Clearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.3 Active and Passive Protection from Infectious Diseases . . . . . . . 5
1.3.4 Antigenic Variation .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.5 Tumour Immunology .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Prevention of Infectious Diseases by Vaccination.. . . . . . . . . . . . . . . . . . . . . . 6
1.4.1 Viral and Bacterial Vaccines Currently in Use . . . . . . . . . . . . . . . . . . 8
1.4.2 Routes of Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4.3 Malaria Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.4.4 Experimental Prophylactic and Therapeutic Vaccines . . . . . . . . . . 11
2 Humoral and Cellular Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1 Humoral Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.1.1 Antibody Titres and Antibody Concentrations .. . . . . . . . . . . . . . . . . 14
2.1.2 Two Assays for Humoral Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2 Cellular Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.2.1 Assays for Cellular Immunity.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3 Standard Statistical Methods for the Analysis
of Immunogenicity Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.2 Geometric Mean Titres and Concentrations .. . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.2.1 Single Vaccine Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.2 Two Vaccine Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.3 Geometric Mean Fold Increase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.3.1 Analysis of a Single Geometric Mean Fold Increase . . . . . . . . . . . 25
3.3.2 Analysis of Two Geometric Mean Fold Increases . . . . . . . . . . . . . . 25
3.3.3 A Misconception about Fold Increases
and Baseline Imbalance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
后面目录略。。。

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