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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

Number of clinical trials registered per year.
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vaccines-03-00186-f001: Number of clinical trials registered per year.

Mentions: ClinicalTrial.gov yielded more than 1200 clinical programs as of November 7, 2014. Many of which did not satisfy our inclusion criteria and 234 clinical trials were extracted definitely. Figure 1 shows number of trials registered per year. ClinicalTrial.gov started registration in 1999 therefore it included the trials which had started before 1999. Since 2005, from 15 to 25 trials are registered per year. More than three quarters of selected clinical trials are phase 1 and they account for 78.2% (183 trials) of all clinical trials. Phase 1/2 and 2 trials make up 9.0% (21 trials) and 12.0% (28 trials) of the total respectively, and phase 3 represent only 1.0% (2 trials) of all trials (Figure 1). Most of the clinical trials are conducted in the U.S. and Europe, and no clinical trial is conducted in Japan. In Japan, single clinical trial for plasmid DNA vaccine on cytomegalovirus-seropositive recipients undergoing allogeneic, hematopoietic cell transplant was registered in ClinicalTrials.gov [1]; however, it does not meet our inclusion criteria (intending to prophylaxis of infection) and was excluded from 234 clinical trials selected finally.


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 registered per year.
© Copyright Policy
Related In: Results  -  Collection

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

vaccines-03-00186-f001: Number of clinical trials registered per year.
Mentions: ClinicalTrial.gov yielded more than 1200 clinical programs as of November 7, 2014. Many of which did not satisfy our inclusion criteria and 234 clinical trials were extracted definitely. Figure 1 shows number of trials registered per year. ClinicalTrial.gov started registration in 1999 therefore it included the trials which had started before 1999. Since 2005, from 15 to 25 trials are registered per year. More than three quarters of selected clinical trials are phase 1 and they account for 78.2% (183 trials) of all clinical trials. Phase 1/2 and 2 trials make up 9.0% (21 trials) and 12.0% (28 trials) of the total respectively, and phase 3 represent only 1.0% (2 trials) of all trials (Figure 1). Most of the clinical trials are conducted in the U.S. and Europe, and no clinical trial is conducted in Japan. In Japan, single clinical trial for plasmid DNA vaccine on cytomegalovirus-seropositive recipients undergoing allogeneic, hematopoietic cell transplant was registered in ClinicalTrials.gov [1]; however, it does not meet our inclusion criteria (intending to prophylaxis of infection) and was excluded from 234 clinical trials selected finally.

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