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.
Highlights
Since the first success of the smallpox vaccine in the 18th century, various types of vaccines have been developed: the live-attenuated vaccines, inactivated vaccines, subunit vaccines, toxoid vaccines and conjugate vaccines
We provide the current status of the clinical development and the regulations related to the gene-based vaccines intended for use in the prophylaxis of infectious disease in humans in the U.S, Europe and Japan
In Japan, single clinical trial for plasmid DNA vaccine on cytomegalovirus-seropositive recipients undergoing allogeneic, hematopoietic cell transplant was registered in ClinicalTrials.gov [10]; it does not meet our inclusion criteria and was excluded from 234 clinical trials selected
Summary
Since the first success of the smallpox vaccine in the 18th century, various types of vaccines have been developed: the live-attenuated vaccines, inactivated vaccines, subunit vaccines, toxoid vaccines and conjugate vaccines. There is still a long list of infectious diseases for which no effective vaccines exist, such as HIV, dengue virus, Ebola virus and malaria, and for which improved vaccines are needed such as tuberculosis and influenza virus. Recent vaccine development has concentrated on a new alternative approach, gene-based vaccines such as plasmid DNA vaccines and viral-vectored vaccines [1]. DNA vaccines consist of a bacterial plasmid DNA backbone incorporating the antigen-encoding gene of the pathogens such as the viral envelope region. The plasmid DNA is taken up into the host cell and the antigen is expressed intracellularly. The antigenic protein is processed via the endogenous MHC class I pathway, resulting in the induction of the response of CD8+ cytotoxic T lymphocytes (CTLs)
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