A 12-Month-Interval Dosing Study in Adults Indicates That a Single Dose of the National Institute of Allergy and Infectious Diseases Tetravalent Dengue Vaccine Induces a Robust Neutralizing Antibody Response

J Infect Dis. 2016 Sep 15;214(6):832-5. doi: 10.1093/infdis/jiw067. Epub 2016 Feb 16.

Abstract

The ideal dengue vaccine will provide protection against all serotypes of dengue virus and will be economical and uncomplicated in its administration. To determine the ability of a single dose of the live attenuated tetravalent dengue vaccine TV003 to induce a suitable neutralizing antibody response, a placebo-controlled clinical trial was performed in 48 healthy adults who received 2 doses of vaccine or placebo administered 12 months apart. Evaluation of safety, vaccine viremia, and neutralizing antibody response after each dose indicated that the first dose of vaccine was capable of preventing infection with the second dose, thus indicating that multiple doses are unnecessary.

Clinical trials registration: NCT01782300.

Keywords: clinical trial; dengue vaccine; live attenuated tetravalent.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antibodies, Neutralizing / blood*
  • Antibodies, Viral / blood*
  • Dengue / immunology
  • Dengue / prevention & control*
  • Dengue Vaccines / administration & dosage
  • Dengue Vaccines / adverse effects
  • Dengue Vaccines / immunology*
  • Double-Blind Method
  • Humans
  • Immunization Schedule
  • National Institute of Allergy and Infectious Diseases (U.S.)
  • Placebos / administration & dosage
  • United States
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Dengue Vaccines
  • Placebos
  • Vaccines, Attenuated

Associated data

  • ClinicalTrials.gov/NCT01782300