Guidelines for assuring the quality and non clinical safety evaluation of DNA vaccines, Annex 1, TRS 941

Overview

These guidelines concentrate on the quality control and on nonclinical testing of vaccines based on bacterial plasmid DNA intended for use in humans. The purpose of this document is to provide guidance on:

• appropriate methods for the control of the manufacture and characterization of plasmid DNA vaccines;
• appropriate approaches for the nonclinical testing of plasmid DNA vaccines; and
• information specifi c to plasmid DNA vaccines that should be included in submissions by manufacturers to national regulatory authorities in support of applications for the authorization of clinical trials and for marketing.

The development and application of DNA vaccines continues to evolve. Since these guidelines were fi rst adopted in 1996, many clinical trials of DNA vaccines have taken place and much experience in their manufacture and control has accrued. This revision refl ects the experience gained, especially in relation to the data derived from nonclinical safety testing and the concerns expressed in the fi rst version of these guidelines. The control of these vaccines should continue to be approached in a fl exible manner to enable further modifi cations as more experience is gained in their production and use. The intention is to provide a scientifi cally sound basis for the manufacture and control of these vaccines for use in humans so as to ensure their consistent safety and effi cacy. Individual countries may wish to use this document to develop their own national guidelines for DNA vaccines.

Full version of  WHO Technical Report Series No. 941