Immunogenicity and safety of two live-attenuated tetravalent dengue vaccine formulations in healthy Australian adults

We conducted a Phase 1b study to evaluate the immunogenicity and safety of two live attenuated tetravalent dengue vaccines in healthy adult volunteers. After one injection, all subjects reported systemic reactions consistent with a mild dengue-like syndrome. Seven volunteers developed dengue 3 virae...

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Bibliographic Details
Main Authors: Scott Kitchener, Michael Nissen, Peter Nasveld, Remi Forrat, Sutee Yoksan, Jean Lang, Jean François Saluzzo
Other Authors: University of Queensland
Format: Article
Published: 2018
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Online Access:https://repository.li.mahidol.ac.th/handle/123456789/23078
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Institution: Mahidol University
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Summary:We conducted a Phase 1b study to evaluate the immunogenicity and safety of two live attenuated tetravalent dengue vaccines in healthy adult volunteers. After one injection, all subjects reported systemic reactions consistent with a mild dengue-like syndrome. Seven volunteers developed dengue 3 viraemia after vaccination. All subjects developed a neutralizing antibody response against serotype 3 with partial response against other serotypes. The trial was stopped early (after 10 subjects enrolled) due to formulation issues, which were related to the dengue 3 vaccine component. Managing viral interference and balancing attenuation to produce acceptable tetravalent immunogenicity with minimal reactogenicity may be a recurring problem for future multivalent live vaccines. © 2005 Elsevier Ltd. All rights reserved.