JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

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
Journal of Infectious Diseases 2013 March 15, 207 (6): 957-65
23329850

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.

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