DNA vaccines: Development, standardization and regulation

被引：26

作者：

Cichutek, K ^{[1
]}

机构：

[1] Paul Ehrlich Inst, Dept Med Biotechnol, D-63225 Langen, Germany

来源：

INTERVIROLOGY | 2000年 / 43卷 / 4-6期

关键词：

naked DNA; DNA vaccination; gene therapy regulations; theoretical risks;

D O I：

10.1159/000054001

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

Nucleic acid vaccines contain nonvectored nucleic acids intended to be used as prophylactic vaccines in humans or animals. In addition to the Guidelines Assuring the Quality of DNA Vaccines published by the WHO, further standards for the manufacture and preclinical testing are being developed. Theoretical risks have been taken into account and assessed before human use has been considered. Legal requirements for clinical trials and licensing of nucleic vaccines are in place in Germany and other European member states which al low further testing and development of proprietary medicinal products based on nucleic acids and intended for prophylactic vaccination. Copyright (C) 2001 S. Karger AG, Basel.

引用

页码：331 / 338

页数：8

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