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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

Diseases targeted by prophylactic gene-based vaccines.
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vaccines-03-00186-f002: Diseases targeted by prophylactic gene-based vaccines.

Mentions: Of the 234 clinical trials, the vast majority (141 trials; 60.3%) of clinical trials have addressed HIV infection. Influenza infection, malaria and tuberculosis are the next popular applications for gene-based vaccines, at 12.4% (29 trials), 8.5% (20 trials) and 8.5% (20 trials) of all clinical trials respectively (Figure 2). These infectious diseases own about 90% of all clinical trials. The fifth most common targeted disease is Ebola virus disease and three clinical trials were newly registered in 2014.


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

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

Diseases targeted by prophylactic gene-based vaccines.
© Copyright Policy
Related In: Results  -  Collection

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

vaccines-03-00186-f002: Diseases targeted by prophylactic gene-based vaccines.
Mentions: Of the 234 clinical trials, the vast majority (141 trials; 60.3%) of clinical trials have addressed HIV infection. Influenza infection, malaria and tuberculosis are the next popular applications for gene-based vaccines, at 12.4% (29 trials), 8.5% (20 trials) and 8.5% (20 trials) of all clinical trials respectively (Figure 2). These infectious diseases own about 90% of all clinical trials. The fifth most common targeted disease is Ebola virus disease and three clinical trials were newly registered in 2014.

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