Initiative for Vaccine Research (IVR)

WHO informal consultation on characterization and quality aspect of vaccines based on live viral vectors, December 2003

References

  • WHO Technical Report Series (in press). Guidelines for nonclinical evaluation of vaccines. Adopted by the Expert Committee on Biological Standardisation at it's 54th meeting, November 2003
  • WHO Technical Report Series 924 (2004), annex 1. Guidelines for clinical evaluation of vaccines: regulatory expectations.
  • Note for Guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products. CPMP/BWP/3088/99.London. 2001.
  • Requirements for the Use of Animal Cells as in vitro Substrates for the production of Biologicals. Annex 1. WHO TRS 878, 1998.
  • Guidelines for assuring quality of DNA vaccines. Annex 3. WHO TRS 878, 1998.
  • Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. Annex 3. WHO TRS 814, 1991.
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Table of contents

  1. Meeting Report Content
  2. Meeting Summary
  3. Introduction
  4. Meeting Objectives
  5. Scope of the Consultation
  6. Characterization of vaccine candidates and nonclinical testing
  7. Reference materials and standardization
  8. Review of vectored vaccines in clinical trials
  9. Regulatory issues for live viral-vectored vaccines
  10. Recommendations to WHO and priorities for future work
  11. References
  12. List of Participants