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

Research output: Contribution to journal › Article › peer-review

33 Scopus citations

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

@article{188c167fbf3645308014a932fbbcbc77,

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",

pages = "454--460",

journal = "American Journal of Tropical Medicine and Hygiene",

issn = "0002-9637",

publisher = "American Society of Tropical Medicine and Hygiene",

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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

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.

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.

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EP - 460

JO - American Journal of Tropical Medicine and Hygiene

JF - American Journal of Tropical Medicine and Hygiene

IS - 3

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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