A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: A randomized, double-blind clinical trial

Anna P. Durbin, Beth D. Kirkpatrick, Kristen K. Pierce, Daniel Elwood, Catherine J. Larsson, Janet C. Lindow, Cecilia Tibery, Beulah P. Sabundayo, Donna Shaffer, Kawsar R. Talaat, Noreen A. Hynes, Kimberli Wanionek, Marya P. Carmolli, Catherine J. Luke, Brian R. Murphy, Kanta Subbarao, Stephen S. Whitehead

Research output: Contribution to journalArticle

Abstract

Background. Dengue virus (DENV) causes hundreds of millions of infections annually. Four dengue serotypes exist, and previous infection with one serotype increases the likelihood of severe disease with a second, heterotypic DENV infection.Methods. In a randomized, placebo-controlled study, the safety and immunogenicity of 4 different admixtures of a live attenuated tetravalent (LATV) dengue vaccine were evaluated in 113 flavivirus-naive adults. Serum neutralizing antibody levels to all 4 dengue viruses were measured on days 0, 28, 42, and 180.Results. A single dose of each LATV admixture induced a trivalent or better neutralizing antibody response in 75%-90% of vaccinees. There was no significant difference in the incidence of adverse events between vaccinees and placebo-recipients other than rash. A trivalent or better response correlated with rash and with non-black race (P <. 0001). Black race was significantly associated with a reduced incidence of vaccine viremia.Conclusions. TV003 induced a trivalent or greater antibody response in 90% of flavivirus-naive vaccinees and is a promising candidate for the prevention of dengue. Race was identified as a factor influencing the infectivity of the LATV viruses, reflecting observations of the effect of race on disease severity in natural dengue infection.Clinical Trials Registration NCT01072786.

Original languageEnglish (US)
Pages (from-to)957-965
Number of pages9
JournalJournal of Infectious Diseases
Volume207
Issue number6
DOIs
StatePublished - 2013

Keywords

  • clinical trial
  • dengue vaccine
  • live attenuated tetravalent

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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    Durbin, A. P., Kirkpatrick, B. D., Pierce, K. K., Elwood, D., Larsson, C. J., Lindow, J. C., Tibery, C., Sabundayo, B. P., Shaffer, D., Talaat, K. R., Hynes, N. A., Wanionek, K., Carmolli, M. P., Luke, C. J., Murphy, B. R., Subbarao, K., & Whitehead, S. S. (2013). A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: A randomized, double-blind clinical trial. Journal of Infectious Diseases, 207(6), 957-965. https://doi.org/10.1093/infdis/jis936