Vaccines: From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use, 1st Edition (Hardback) book cover


From Concept to Clinic: A Guide to the Development and Clinical Testing of Vaccines for Human Use, 1st Edition

Edited by Lawrence C. Paoletti, Pamela McInnes

CRC Press

224 pages

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Hardback: 9780849311680
pub: 1998-07-29

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Designed with academic vaccine researchers in mind, this book presents a road map of how a vaccine develops from an idea in a researcher's imagination, to the lab bench, through preclinical evaluation, and into the clinic for safety and immunogenicity. The result of the editors' own efforts to glean practical information on the steps necessary to manufacture, bottle, and test their vaccines for clinical trials, this book provides answers to researcher questions such as:

  • How do I identify antigens that would produce effective vaccines?

  • Can I produce a clinical lot of vaccine in my laboratory?

  • How should a vaccine be bottled?

  • Which FDA expectations must I meet?

  • What is an IND application and how do I file it?

  • Which CFRs apply to production of a vaccine?
  • Table of Contents

    Foreword, G. Siber

    Identification of Vaccine Targets, R. Rappuoli and G. Del Giudice

    Use of Animals for Vaccine Development, A.B. Onderdonk and R.C. Kennedy

    Validation and Standardization of Serologic Methods for Evaluation of Clinical Immune Response to Vaccines, D.V. Madore, N.M. Strong, and S.A. Quataert

    Considerations in the Production of Vaccines for Use in Phase 1 Clinical Trials and Preparation of the Manufacturer's Protocol, L.C. Paoletti

    Helpful Hints for Preparing an IND Application, M.J. Mattheis and P.M. McInnes

    IND Application Submissions for Vaccines: Perspectives of IND Reviewers, D.K.F. Chandler, L.D. McVittie, and J.M. Novack

    Technology Transfer: What You Always Wanted to Know But Were Afraid to Ask, J.A. Biddle

    Development of a Transmission-Blocking Vaccine: Malaria, Mosquitoes, and Medicine, D.C. Kaslow

    The Victories and Vexations of Vaccine Production -The Varicella Vaccine, M. Takahashi

    Subject Categories

    BISAC Subject Codes/Headings:
    MEDICAL / Pharmacology