Safety and Immunogenicity of a Dengue Virus Serotype-1 Purified-Inactivated Vaccine: Results of a Phase 1 Clinical Trial
Luis Javier Martineza b c, Leyi Lina b c, Jason M Blaylocka b c, Arthur G. Lyonsb c d, Kristen M. Bauerb c d, Rafael A. De La Barrerab c, Monika Simmonsa b c, Richard G. Jarmana b c, Jeffrey R. Curriera b c, Heather Fribergb c d, Janine Dankob c d, Nimfa C. Teneza-Morab c d, Joseph Robert Putnaka b c, Kenneth H. Eckelsa b c✉, Stephen James Thomasb c d
- aWalter Reed Army Institute of Research , Silver Spring , Maryland
- bWalter Reed Army Institute of Research, Silver Spring, Maryland
- cNaval Medical Research Center, Silver Spring, Maryland
- dNaval Medical Research Center , Silver Spring , Maryland
- ✉Corresponding author
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Abstract
We describe the results from a human clinical trial of a dengue virus serotype-1, purified-inactivated vaccine (DENV-1 PIV) adjuvanted with aluminum hydroxide. This first-in-man, Phase 1, open-label clinical trial consisted of two groups of flavivirus-naïve healthy adult volunteers that received two intramuscular vaccine doses of either 2.5 μg or 5 μg of DENV-1 PIV administered on days 0 and 28. Following vaccination, both vaccine doses exhibited an acceptable safety profile with minimal injection site and systemic reactions. By study day 42, 2 weeks following the second vaccine dose, all volunteers in both vaccine groups developed serum-neutralizing antibodies against DENV-1. Additional testing using an enzyme-linked immunosorbent assay demonstrated induction of a humoral immune response following both vaccine doses. The DENV-1 PIV was safe and immunogenic in a small number of volunteers supporting development and further testing of a tetravalent DENV PIV formulation.
TL;DRThe DENV-1 PIV was safe and immunogenic in a small number of volunteers supporting development and further testing of a tetravalent DENV PIV formulation and induction of a humoral immune response following both vaccine doses. (Semantic Scholar)