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Published on: April 10, 2018
Identifying protective dengue vaccines: guide to mastering an empirical process
1Department of Preventive Medicine and Biometrics, Uniformed University of the Health Sciences, Bethesda, MD, USA.
Vaccine
|July 31, 2013
Summary
A new dengue vaccine failed to protect against Dengue 2 virus, despite prior antibody responses. Preclinical testing needs stricter criteria to ensure vaccine effectiveness against each dengue serotype.
Area of Science:
- Virology and Immunology
- Vaccine Development
- Infectious Diseases
Background:
- A live-attenuated tetravalent chimeric yellow fever-dengue vaccine trial showed no protection against Dengue 2 virus (DENV-2).
- This was unexpected given that prior doses induced broad neutralizing antibodies.
- Preclinical studies indicated the monotypic DENV-2 vaccine component did not meet solid protection criteria against live virus challenge.
Purpose of the Study:
- To re-evaluate preclinical testing criteria for dengue vaccines.
- To suggest enhanced Phase I and Phase II clinical trial designs for tetravalent dengue vaccines.
- To investigate the role of Dengue virus non-structural protein 1 (NS1) in severe dengue pathogenesis.
Main Methods:
- Review of clinical trial data for a live-attenuated tetravalent chimeric yellow fever-dengue vaccine.
- Analysis of pre-clinical subhuman primate study data for monotypic DENV-2 vaccine components.
- Proposed modifications to Phase I and Phase II clinical trial protocols, including monotypic challenge and immune response studies.
Main Results:
- The tetravalent vaccine failed to provide protection against DENV-2.
- Monotypic DENV-2 vaccine components in preclinical studies did not meet established protection criteria.
- Immunological interference phenomena are suggested as a potential issue with tetravalent dengue vaccines.
Conclusions:
- Preclinical testing for dengue vaccines requires more rigorous criteria for solid homotypic immunity.
- Phase I and Phase II clinical trials should incorporate direct monotypic live-attenuated virus challenges to assess individual component efficacy.
- Investigating DENV NS1's role in severe dengue and developing immunity against it may be crucial for preventing severe disease.
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