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