Ronald W. Ellis - Combination Vaccines: Development, Clinical Research and Approval

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title	:	Combination Vaccines : Development, Clinical Research, and Approval
author	:	Ellis, Ronald W.
publisher	:	Humana Press
isbn10 | asin	:	0896037177
print isbn13	:	9780896037175
ebook isbn13	:	9780585262291
language	:	English
subject	Combined vaccines, Vaccines, Combined.
publication date	:	1999
lcc	:	RM281.C65 1999eb
ddc	:	615/.372
subject	:	Combined vaccines, Vaccines, Combined.

Page iii Combination Vaccines Development, Clinical Research, And Approval Edited by Ronald W. Ellis BioChem Pharma, Inc., Northborough, MA HUMANA PRESS TOTOWA, NEW JERSEY

Page iv 1999 Humana Press Inc. 999 Riverview Drive, Suite 208 Totowa, New Jersey 07512 All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise without written permission from the Publisher. All articles, comments, opinions, conclusions, or recommendations are those of the author(s), and do not necessarily reflect the views of the publisher. This publication is printed on acid-free paper. ANSI Z39.48-1984 (American National Standards Institute) Permanence of Paper for Printed Library Materials. Cover design by Patricia F. Cleary. For additional copies, pricing for bulk purchases, and/or information about other Humana titles, contact Humana at the above address or at any of the following numbers: Tel: 973-256-1699; Fax: 973-256-8341; E-mail: humana@humanapr.com or visit our website at http://humanapress.com Photocopy Authorization Policy: Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Humana Press Inc., provided that the base fee of US $10.00 per copy, plus US $00.25 per page, is paid directly to the Copyright Clearance Center at 222 Rosewood Drive, Danvers, MA 01923. For those organizations that have been granted a photocopy license from the CCC, a separate system of payment has been arranged and is acceptable to Humana Press Inc. The fee code for users of the Transactional Reporting Service is: [0-89603-717-7/99 $10.00 + $00.25]. Printed in the United States of America. 10 9 8 7 6 5 4 3 2 1 Combination vaccines: development, clinical research, and approval / edited by Ronald W. Ellis. p. cm. Includes index. ISBN 0-89603-717-7 (alk. paper) 1. Combined vaccines.I. Ellis, Ronald W. [DNLM: 1. Vaccines, Combined. QW 805 C7308 1999] RM281.C65 1999 615'.372-dc21 DNLM/DLC for Library of Congress 98-55262 CIP

Page v To my wife, Danielle, and children, Jacob and Miriam, for their love, patience, and support.

Page vii Preface Breakthroughs in immunology, molecular biology, biochemistry, and other related fields coupled with a greater understanding of pathogenesis have resulted in the research and development (R&D) of many new vaccines as well as improvements in several existing ones. If such vaccines are widely used in at-risk populations, then it should be possible to prevent much morbidity and mortality. Combination vaccines (defined as two or more vaccines in a physically mixed preparation) provide a way in which to encourage increased use of a wide range of vaccines in a broad population. The combination vaccine usually is mixed at the time of manufacture, but also may be mixed immediately before being given to the subject. The schedule for routine pediatric immunization used to be relatively simple, consisting of four doses of diphtheria-tetanus-pertussis (DTP) and one of measles-mumps-rubella (MMR) as injected vaccines as well as oral polio vaccine (OPV). This schedule had remained unchanged until about the last 10 years. During the 1990s, several new vaccines have been introduced into the routine immunization schedule for the first two years of life and are becoming more widely used. Conjugated polysaccharide vaccines for Haemophilus influenzae type b (Hib), given in three to four doses, were demonstrated effective for preventing disease in young infants. Immunization with recombinant hepatitis B (HB) vaccines (three doses) also became recommended during the first year of life, since immunization of high-risk adult populations had failed to reduce the rate of new HB infections. More recently inactivated polio vaccine (IPV), another injected vaccine, has been recommended in the US to replace the first two doses of OPV in order to reduce the incidence of already rare cases of vaccine-associated polio following the initial dose(s) of OPV. Finally, varicella (V) vaccine, now given as a single dose in the second year of life, was introduced to prevent chickenpox. As a consequence, what started as five injections in the first two years of life has become as high as 15, leading parents and health-care practitioners to become concerned that young children could become like pincushions! This plethora of vaccines creates increased needs for recordkeeping and storage that could discourage health-care providers from administering the full range of indicated vaccines. These issues have stimulated major efforts toward the development of multidisease combination vaccines that could reduce the number of injections in children.

Page viii The foregoing individual vaccines are monovalent, i.e., each one is directed against a viral or bacterial pathogen that has a single antigenic type, meaning that its major antigenic determinants are group-common. However, there are many significant pathogens that have multiple serotypes or serogroups. There are multivalent combination vaccines available for several such pathogens, including poliovirus (3 types), influenza virus (3 types),

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