World Health Organization : Year 1995 ; World Health Organization Blg, No. 95.1, (Part S1-2): Manual of Laboratory Methods for Testing of Vaccines Used in the World Health Organization Expanded Programme on Immunization

By World Health Organization

Book Id: WPLBN0000047705
Format Type: PDF eBook:
File Size: 4.75 MB
Reproduction Date: 2005

Title:	World Health Organization : Year 1995 ; World Health Organization Blg, No. 95.1, (Part S1-2): Manual of Laboratory Methods for Testing of Vaccines Used in the World Health Organization Expanded Programme on Immunization
Author:	World Health Organization
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Health Organization, B. W. (n.d.). World Health Organization : Year 1995 ; World Health Organization Blg, No. 95.1, (Part S1-2). Retrieved from http://gutenberg.cc/

Description
Medical Reference Publication

Excerpt
PREFACE In 1982, with the aim of providing guidance for the standardization of tests needed to ensure the safety and efficacy of vaccines, the World Health Organization (WHO) issued a document entitled Manual of details of tests required on final vaccines used in the WHO Expanded Programme on Immunization (unpublished document BLGlUNDPl82.1 Rev. 1). This document was updated in 1985 (unpublished document BLGlUNDPl82.1 Rev. 1 Corr. 1). As a result of changes in some of the potency tests and the development of alternative techniques for testing the potency of bacterial vaccines, and in an attempt to present the information in a more useful way for testing laboratories, details of the potency tests for live viral vaccines and bacterial vaccines were revised and reissued provisionally in two documents, Laboratory methods for the titration of live virus vaccines using cell culture techniques (unpublished document BLGlEPIl89.1) and Laboratory methods for the testing for potency of diphtheria (D), tetanus (T), pertussis (P) and combined vaccines (unpublished document BLGl92.1).

Table of Contents
CONTENTS Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 PART 1 . GENERAL 1. General introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2 . Standardization in vaccine potency testing . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 3 . The use of laboratory animals in the quality control of vaccines . . . . . . . . . . . . 20 4 . General laboratory procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5 . Laboratory safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 6 . Preparation of hyperimmune animal sera . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 7 . Testing of antisera for use in vaccine potency testing . . . . . . . . . . . . . . . . . . . 48 8 . Preparation and preservation of cell cultures . . . . . . . . . . . . . . . . . . . . . . . . . 52 PART 2 . POTENCY CONTROL OF LIVE VIRAL VACCINES 9 . Live oral poliomyelitis vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 10 . Titration of human sera for neutralizing antibodies to poliovirus . . . . . . . . . . . 75 11 . Determination of measles antibody by haemagglutination inhibition . . . . . . . . . 83 12. Live measles vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 13. Live mumps virus vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 14. Live rubella virus vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 15 . Combined live viral vaccines against measles, mumps and rubella . . . . . . . . . 104 16. Yellow fever vaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 PART 3 . POTENCY CONTROL OF BACTERIAL VACCINES 17 . Introduction to potency control of bacterial vaccines . . . . . . . . . . . . . . . . . . 115 18 . Traditional methods for testing the potency of vaccines containing adsorbed diphtheria and tetanus toxoids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 19 . Assay for testing the potency of whole-cell pertussis vaccines in monovalent or combined form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 20 . Introduction to serological methods for testing the potency of vaccines containing diphtheria and tetanus toxoids . . . . . . . . . . . . . . . . . . . . . . . . . . 129