title: 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.
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.
authors: Department of International Health, Johns Hopkins Bloomberg School of Public Health, 624 N Broadway, Rm 217, Baltimore, MD 21205, USA. adurbin@jhsph.edu
authors: Anna P
authors: AP
authors: Durbin
authors: Beth D
authors: BD
authors: Kirkpatrick
authors: Kristen K
authors: KK
authors: Pierce
authors: Daniel
authors: D
authors: Elwood
authors: Catherine J
authors: CJ
authors: Larsson
authors: Janet C
authors: JC
authors: Lindow
authors: Cecilia
authors: C
authors: Tibery
authors: Beulah P
authors: BP
authors: Sabundayo
authors: Donna
authors: D
authors: Shaffer
authors: Kawsar R
authors: KR
authors: Talaat
authors: Noreen A
authors: NA
authors: Hynes
authors: Kimberli
authors: K
authors: Wanionek
authors: Marya P
authors: MP
authors: Carmolli
authors: Catherine J
authors: CJ
authors: Luke
authors: Brian R
authors: BR
authors: Murphy
authors: Kanta
authors: K
authors: Subbarao
authors: Stephen S
authors: SS
authors: Whitehead
mesh_terms: D000328:Adult; D044467:American Indian or Alaska Native; D000914:Antibodies, Viral / Q000097:blood*; D044383:Black People; D003715:Dengue / Q000517:prevention & control; D053059:Dengue Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D003716:Dengue Virus / Q000276:immunology*; D004311:Double-Blind Method; D005076:Exanthema / Q000821:virology; D005260:Female; D006801:Humans; D008297:Male; D044468:Native Hawaiian or Pacific Islander; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014766:Viremia / Q000821:virology; D044465:White People; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D053059:Dengue Vaccines; D014613:Vaccines, Attenuated