Cichutek K
Department of Medical Biotechnology, Paul-Ehrlich-Institute, Langen, Germany.
Ann N Y Acad Sci. 1995 Nov 27;772:178-85. doi: 10.1111/j.1749-6632.1995.tb44743.x.
Nucleic acid vaccines are promising candidates for easy-to-handle and cost-effective vaccines that combine the safety of subunit vaccines with the efficacy of live virus vaccines. In order to obtain marketing authorization for a nucleic acid vaccine in all member states of the European Union, a single application dossier has to be filed with the European Agency for the Evaluation of Medicinal Products. Notes for Guidance on the data necessary to support applications are available. The preclinical development of nucleic acid vaccines has to follow procedures of contained use according to the relevant EC directives which were translated into the German Gene Law. Clinical trials in Germany would follow the known procedures defined in the German Drug Law, whereas the Gene Law is not applicable. Clinical trials should be started only after having obtained consent of the Commission for Gene Therapy Trials formed under the auspices of the Federal Chamber of Physicians. Experience in intramuscular nucleic acid inoculation of animals has been gained using expression constructs comprising single and multiple genes of simian immunodeficiency virus. Specific antibodies were induced against multiple antigens. No adverse effects of nucleic acid inoculations were found, but more rigorous testing of specific safety problems will have to be performed.
核酸疫苗有望成为易于操作且具成本效益的疫苗，它结合了亚单位疫苗的安全性和活病毒疫苗的有效性。为了在欧盟所有成员国获得核酸疫苗的上市许可，必须向欧洲药品评估局提交一份单一的申请文件。现有关于支持申请所需数据的指导说明。核酸疫苗的临床前开发必须遵循根据相关欧盟指令制定的封闭使用程序，这些指令已被纳入德国《基因法》。德国的临床试验将遵循德国《药品法》规定的已知程序，而《基因法》不适用。只有在获得由联邦医师协会主持成立的基因治疗试验委员会的同意后，才能开始临床试验。使用包含猿猴免疫缺陷病毒单基因和多基因的表达构建体，已积累了动物肌肉内接种核酸的经验。诱导产生了针对多种抗原的特异性抗体。未发现核酸接种的不良反应，但必须对特定的安全性问题进行更严格的测试。
