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Immunization of Adult Zebrafish for the Preclinical Screening of DNA-based Vaccines
Published on: October 30, 2018
Human clinical trials of plasmid DNA vaccines
Margaret A Liu1, Jeffrey B Ulmer
1Transgene S.A., 11 rue de Molsheim, 67082 Strasbourg Cedex, France.
Abstract:
This article gives an overview of DNA vaccines with specific emphasis on the development of DNA vaccines for clinical trials and an overview of those trials. It describes the preclinical research that demonstrated the efficacy of DNA vaccines as well as an explication of the immunologic mechanisms of action. These include the induction of cognate immune responses, such as the generation of cytolytic T lymphocytes (CTL) as well as the effect of the plasmid DNA upon the innate immune system. Specific issues related to the development of DNA as a product candidate are then discussed, including the manufacture of plasmid, the qualification of the plasmid DNA product, and the safety testing necessary for initiating clinical trials. Various human clinical trials for infectious diseases and cancer have been initiated or completed, and an overview of these trials is given. Finally, because the early clinical trials have shown less than optimal immunogenicity, methods to increase the potency of the vaccines are described.
Insights
DNA vaccines show promise in preclinical studies by activating immune responses. Clinical trials are underway for infectious diseases and cancer, with ongoing research to improve vaccine potency.
Area of Science:
- Immunology
- Vaccinology
- Molecular Biology
Background:
- DNA vaccines represent a novel approach to immunization, utilizing plasmid DNA to elicit immune responses.
- Preclinical research has established the efficacy of DNA vaccines, demonstrating their ability to induce specific immune responses.
Purpose of the Study:
- To provide an overview of DNA vaccine development for clinical trials.
- To discuss the immunologic mechanisms underlying DNA vaccine action.
- To examine product development, manufacturing, and safety considerations for DNA vaccines.
Main Methods:
- Review of preclinical data demonstrating DNA vaccine efficacy.
- Explication of immunologic mechanisms, including innate and adaptive immune system activation.
- Analysis of clinical trial data for infectious diseases and cancer.
Main Results:
- DNA vaccines effectively induce cognate immune responses, including cytolytic T lymphocytes (CTLs).
- Plasmid DNA influences the innate immune system, contributing to vaccine efficacy.
- Clinical trials have been initiated and completed for various applications, including infectious diseases and cancer.
Conclusions:
- DNA vaccines have demonstrated potential in preclinical and early clinical studies.
- Challenges in manufacturing, product qualification, and safety testing have been addressed.
- Enhancing immunogenicity remains a key focus for improving DNA vaccine potency and clinical success.
