Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine: Results of a phase 1 clinical trial

Luis Javier Martinez; Leyi Lin; Jason M. Blaylock; Arthur G. Lyons; Kristen M. Bauer; Rafael De La Barrera; Monika Simmons; Richard G. Jarman; Jeffrey R. Currier; Heather Friberg; Janine R. Danko; Nimfa C. Teneza-Mora; J. Robert Putnak; Kenneth H. Eckels; Stephen J. Thomas

doi:10.4269/ajtmh.14-0819

Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine: Results of a phase 1 clinical trial

Luis Javier Martinez, Leyi Lin, Jason M. Blaylock, Arthur G. Lyons, Kristen M. Bauer, Rafael De La Barrera, Monika Simmons, Richard G. Jarman, Jeffrey R. Currier, Heather Friberg, Janine R. Danko, Nimfa C. Teneza-Mora, J. Robert Putnak, Kenneth H. Eckels^*, Stephen J. Thomas

^*Corresponding author for this work

Medicine

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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-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.

Original language	English
Pages (from-to)	454-460
Number of pages	7
Journal	American Journal of Tropical Medicine and Hygiene
Volume	93
Issue number	3
DOIs	https://doi.org/10.4269/ajtmh.14-0819
State	Published - 1 Sep 2015

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Martinez, L. J., Lin, L., Blaylock, J. M., Lyons, A. G., Bauer, K. M., De La Barrera, R., Simmons, M., Jarman, R. G., Currier, J. R., Friberg, H., Danko, J. R., Teneza-Mora, N. C., Robert Putnak, J., Eckels, K. H., & Thomas, S. J. (2015). Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine: Results of a phase 1 clinical trial. American Journal of Tropical Medicine and Hygiene, 93(3), 454-460. https://doi.org/10.4269/ajtmh.14-0819

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title = "Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine: Results of a phase 1 clinical trial",

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-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.",

author = "Martinez, {Luis Javier} and Leyi Lin and Blaylock, {Jason M.} and Lyons, {Arthur G.} and Bauer, {Kristen M.} and {De La Barrera}, Rafael and Monika Simmons and Jarman, {Richard G.} and Currier, {Jeffrey R.} and Heather Friberg and Danko, {Janine R.} and Teneza-Mora, {Nimfa C.} and {Robert Putnak}, J. and Eckels, {Kenneth H.} and Thomas, {Stephen J.}",

note = "Publisher Copyright: Copyright {\textcopyright} 2015 by The American Society of Tropical Medicine and Hygiene.",

year = "2015",

month = sep,

day = "1",

doi = "10.4269/ajtmh.14-0819",

language = "English",

volume = "93",

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Martinez, LJ, Lin, L, Blaylock, JM, Lyons, AG, Bauer, KM, De La Barrera, R, Simmons, M, Jarman, RG, Currier, JR, Friberg, H, Danko, JR, Teneza-Mora, NC, Robert Putnak, J, Eckels, KH & Thomas, SJ 2015, 'Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine: Results of a phase 1 clinical trial', American Journal of Tropical Medicine and Hygiene, vol. 93, no. 3, pp. 454-460. https://doi.org/10.4269/ajtmh.14-0819

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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.

PY - 2015/9/1

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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.

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JF - American Journal of Tropical Medicine and Hygiene

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ER -

Safety and immunogenicity of a dengue virus serotype-1 purified-inactivated vaccine: Results of a phase 1 clinical trial

Abstract

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