期刊
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
卷 93, 期 3, 页码 454-460出版社
AMER SOC TROP MED & HYGIENE
DOI: 10.4269/ajtmh.14-0819
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资金
- U.S. Army Medical Research and Materiel Command (Fort Detrick, MD)
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-naive healthy adult volunteers that received two intramuscular vaccine doses of either 2.5 mu g or 5 mu g 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 DENY PIV formulation.
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