TY - JOUR
T1 - Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine
T2 - Results of a phase 1 clinical trial
AU - Martinez, Luis Javier
AU - Lin, Leyi
AU - Blaylock, Jason M.
AU - Lyons, Arthur G.
AU - Bauer, Kristen M.
AU - De La Barrera, Rafael
AU - Simmons, Monika
AU - Jarman, Richard G.
AU - Currier, Jeffrey R.
AU - Friberg, Heather
AU - Danko, Janine R.
AU - Teneza-Mora, Nimfa C.
AU - Robert Putnak, J.
AU - Eckels, Kenneth H.
AU - Thomas, Stephen J.
N1 - Publisher Copyright:
Copyright © 2015 by The American Society of Tropical Medicine and Hygiene.
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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 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.
AB - 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 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.
UR - http://www.scopus.com/inward/record.url?scp=84941659249&partnerID=8YFLogxK
U2 - 10.4269/ajtmh.14-0819
DO - 10.4269/ajtmh.14-0819
M3 - Article
C2 - 26149862
AN - SCOPUS:84941659249
SN - 0002-9637
VL - 93
SP - 454
EP - 460
JO - American Journal of Tropical Medicine and Hygiene
JF - American Journal of Tropical Medicine and Hygiene
IS - 3
ER -