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Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan.

Nakayama Y, Aruga A - Vaccines (Basel) (2015)

Bottom Line: Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus.In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan.We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

View Article: PubMed Central - PubMed

Affiliation: Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan. yoshi-nakayama@fuji.waseda.jp.

ABSTRACT
Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

No MeSH data available.


Related in: MedlinePlus

Relationship between gene therapy and gene-based vaccines.
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vaccines-03-00186-f004: Relationship between gene therapy and gene-based vaccines.

Mentions: In the guidance for industry entitled “Guidance for human somatic cell therapy and gene therapy” [11] released in 1998 by the center for biologics evaluation and research (CBER), which is the center within the FDA that regulates biological products, gene therapy is defined as “a medical intervention based on modification of the genetic material of living cells”; this publication specifically stipulates that virus or DNA preparations used as preventive vaccines are not covered (Figure 4). In addition, “cells” refer to those modified ex vivo for subsequent administration to humans or those given directly to the subject to be altered in vivo. Genetic manipulations include those intended for therapeutic or prophylactic purposes, or for cell labeling.


Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan.

Nakayama Y, Aruga A - Vaccines (Basel) (2015)

Relationship between gene therapy and gene-based vaccines.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4494244&req=5

vaccines-03-00186-f004: Relationship between gene therapy and gene-based vaccines.
Mentions: In the guidance for industry entitled “Guidance for human somatic cell therapy and gene therapy” [11] released in 1998 by the center for biologics evaluation and research (CBER), which is the center within the FDA that regulates biological products, gene therapy is defined as “a medical intervention based on modification of the genetic material of living cells”; this publication specifically stipulates that virus or DNA preparations used as preventive vaccines are not covered (Figure 4). In addition, “cells” refer to those modified ex vivo for subsequent administration to humans or those given directly to the subject to be altered in vivo. Genetic manipulations include those intended for therapeutic or prophylactic purposes, or for cell labeling.

Bottom Line: Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus.In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan.We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

View Article: PubMed Central - PubMed

Affiliation: Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University and Waseda University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan. yoshi-nakayama@fuji.waseda.jp.

ABSTRACT
Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

No MeSH data available.


Related in: MedlinePlus