Limits...
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

Number of clinical trials using each vector.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4494244&req=5

vaccines-03-00186-f003: Number of clinical trials using each vector.

Mentions: Of the 234 clinical trials, naked/plasmid DNA is the most-used as the vaccine antigen vector (101 trials). Next, vaccinia virus (76 trials) and adenovirus (75 trials) are the most often-used vectors (Figure 3). They are often used in combination as prime-boost vaccinations to induce high antibody titres, CD4+ T cell frequencies and protective CD8+ T cell responses. In about 85% of clinical trials (201 trials), one or more of these three vectors are applied.


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

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

Number of clinical trials using each vector.
© Copyright Policy
Related In: Results  -  Collection

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

vaccines-03-00186-f003: Number of clinical trials using each vector.
Mentions: Of the 234 clinical trials, naked/plasmid DNA is the most-used as the vaccine antigen vector (101 trials). Next, vaccinia virus (76 trials) and adenovirus (75 trials) are the most often-used vectors (Figure 3). They are often used in combination as prime-boost vaccinations to induce high antibody titres, CD4+ T cell frequencies and protective CD8+ T cell responses. In about 85% of clinical trials (201 trials), one or more of these three vectors are applied.

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