Vaccine Adjuvants: Preparation Methods and Research Protocols (Methods in Molecular Medicine)

354 Pages·2000·1.826 MB·English

by  Derek T. O’Hagan

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Vaccine Adjuvants
M E T H O D S I N M O L E C U L A R M E D I C I N ETM
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M E T H O D S I N M O L E C U L A R M ED I C I N ETM
Vaccine Adjuvants
Preparation Methods and
Research Protocols
Edited by
Derek T. O'Hagan
Chiron Corporation
Emeryville, CA
Humana Press Totowa, New Jersey
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Library of Congress Cataloging-in-Publication Data
Vaccine adjuvants: preparation methods and research protocols / edited by
Derek T. O'Hagan.
p. ; cm. -- (Methods in molecular medicine ; 42)
Includses bibliographical references and index.
ISBN 0-89603-735-5 (alk. paper)
1. Immunological adjuvants. 2. Vaccines. I. O'Hagan, Derek T. II.
Series.
[DNLM: Vaccines--immunology. 2. Adjuvants, Immunologic. QW
805 V1154 2000]
QR187.3. .V33 2000
615(cid:1).372--dc21
99-088373
Preface
Vaccine Adjuvants: Preparation Methods and Research Protocols was
developed to promote the optimal use of immunological adjuvants in preclinical
studies. The book’s primary focus is on the use of adjuvants in vaccination
studies in order to induce potent immune responses against either antigens
derived from infectious organisms or cancer-associated antigens. In general,
our work should be of interest and significant value to researchers who need to
induce potent immune responses against their respective antigens, including those
involved in the development of vaccines for infectious diseases, cancers, fer-
tility regulation, and autoimmune disorders. In addition, the book should
also be valuable for those involved in the selective manipulation of the
immune response, including virologists, bacteriologists, parasitologists, and
immunologists. Each chapter describes a single approach, but includes sugges-
tions as to why the specific adjuvant might be preferred for a given antigen,
depending on which type of immune response is desired. Alternative adjuvant
approaches are presented in detail in such a manner as to permit researchers to
choose those most efficacious for their specific indications.
The main focus of Vaccine Adjuvants: Preparation Methods and
Research Protocols is on the use of adjuvants in vaccines, since it is already
clear that the new generation of vaccines—based on recombinant proteins,
synthetic peptides, or DNA— will require adjuvants for optimal efficacy. Each
chapter describes in detail the preparation and characterization of an adjuvant
or an adjuvant formulation, including recommended protocols for its in vivo
evaluation in preclinical studies. Whenever possible, detailed adjuvant prepa-
ration and characterization methods are presented in each chapter by the indi-
viduals who originally invented or developed the approaches, including specific
examples for guidance. The preparation methods described range from simple
mixing of an antigen with a preformed adjuvant, to a complex formulation
process requiring the antigen to be physically associated within, or entrapped
within, an adjuvant formulation. In all chapters, practical advice and guidance
is provided to allow optimal adjuvant preparation. Each chapter also includes
detailed notes, which highlight important practical points, and warns against
potential pitfalls and problems. Following adjuvant preparation, steps are of-
v
vi Preface
ten necessary to characterize the vaccine/adjuvant formulation, to ensure that
the preparation was successful, and to allow quantitative estimation of impor-
tant parameters, including antigen incorporation or association, and antigen
integrity. Whenever necessary, these steps are described in detail, with full
practical guidance and examples of the expected results. In addition, an over-
view chapter describing the evaluation of novel adjuvants in clinical studies is
included. Also included is a chapter describing recommended guidelines to
evaluate the safety of novel adjuvants and adjuvant formulations.
Derek T. O’Hagan
Contents
Preface ............................................................................................................v
Contributors....................................................................................................ix
1 An Overview of Adjuvant Use .................................................................1
Robert Edelman
2 Harmful and Beneficial Activities of Immunological Adjuvants ............29
Duncan E. S. Stewart-Tull
3 Freund’s Adjuvants................................................................................49
Erik B. Lindblad
4 Aluminum Compounds as Vaccine Adjuvants......................................65
Rajesh K. Gupta and Bradford E. Rost
5 Poly(Lactide-Coglycolide) Microparticles As Vaccine Adjuvants.........91
Derek T. O’Hagan and Manmohan Singh
6 Poly(Methyl Methacrylate) Nanoparticles as Vaccine Adjuvants.......105
Jörg Kreuter
7 Aqueous Formulation of Adjuvant-Active
Nonionic Block Copolymers............................................................121
Charles W. Todd and Mark J. Newman
8 Liposomes As Immunological Adjuvants and Vaccine Carriers.........137
Gregory Gregoriadis, Brenda McCormack,
Mia Obrenovic, Yvonne Perrie, and Roghieh Saffie
9 Immunopotentiating Reconstituted Influenza Virosomes (IRIVs) ......151
Reinhard Glück
10 Cochleates for Induction of Mucosal
and Systemic Immune Responses .................................................179
Susan Gould-Fogerite and Raphael J. Mannino
11 Virus-like Particles As Vaccine Adjuvants..........................................197
Sarah C. Gilbert
12 The Adjuvant MF59: A 10-Year Perspective......................................211
Gary Ott, Ramachandran Radhakrishnan, Jia-Hwa Fang,
and Maninder Hora
vii
viii Contents
13 Preparation of the Syntex Adjuvant Formulation
(SAF, SAF-m, and SAF-1) ..............................................................229
Deborah M. Lidgate
14 The ISCOM™ Technology ..................................................................239
Karin Lövgren-Bengtsson and Bror Morein
15 QS-21 Adjuvant....................................................................................259
Charlotte Read Kensil
16 MPL®Immunostimulant:Adjuvant Formulations.................................273
J. Terry Ulrich
17 Cytokines As Vaccine Adjuvants: The Use of Interleukin-2...............283
Martin A. Giedlin
18 DNA As an Adjuvant............................................................................299
David C. Neujahr and David S. Pisetsky
19 Transcutaneous Immunization............................................................315
Gregory M. Glenn, Tanya Scharton-Kersten,
and Russell Vassell
20 Mutant Heat-Labile Entertoxins As Adjuvants for CTL Induction.......327
Jason A. Neidleman, Gary Ott, and Derek O’Hagan
Index............................................................................................................337
Contributors
ROBERT EDELMAN• Center for Vaccine Development,
Department of Medicine (Geographic Medicine), University of Maryland
School of Medicine, Baltimore, MD
JIA-HWA FANG• Chiron Corporation, Emeryville, CA
MARTIN A. GIEDLIN • Chiron Corporation, Emeryville, CA
SARAH C. GILBERT • The Wellcome Trust Centre for Human Genetics,
University of Oxford, Oxford, UK
GERGORY M. GLENN • Department of Membrane Biochemistry, Walter Reed
Army Institute of Research, Washington, DC
SUSAN GOULD-FOGERITE • Department of Laboratory Medicine
and Pathology, University of Medicine and Dentistry–New Jersey
Medical School, Newark, NJ; BioDelivery Sciences, Inc.
REINHARD GLÜCK • Head, Virology, Swiss Serum and Vaccine Institute
Berne, Berne Switzerland
GREGORY GREGORIADIS • Center for Drug Delivery Research, The School
of Pharmacy, University of London, London, UK
RAJESH K. GUPTA • Wyeth Lederle Laboratories, Vaccines, Pearl River, NY
MANINDER HORA • Chiron Corporation, Emeryville, CA
CHARLOTTE READ KENSIL • Adjuvant and Drug Delivery Research, Aquila
Biopharmaceuticals, Inc., Framingham, MA
JÖRG KREUTER • Institut für Pharmazeutische Technologie, Johann Wolfgang
Goethe-Universität, Biozentrum, Frankfurt am Main, Germany
DEBORAH M. LIDGATE • Roche, Palo Alto, CA
ERIK B. LINDBLAD • Superfos Biosector, Production, Frederikasund,
Denmark
KARIN LÖVGREN-BENGTSSON • Section of Virology, Department
of Veterinary Microbiology, Swedish University of Agricultural
Sciences, Uppsala, Sweden
RAPHAEL J. MANNINO • University of Medicine and Dentistry—New Jersey
Medical School, Newark, NJ; and BioDelivery Sciences, Inc.
BRENDA MCCORMACK • Center for Drug Delivery Research, The School
of Pharmacy, University of London, London, United Kingdom
ix