Testing of a Dengue 2 Live-Attenuated Vaccine (Strain 16681 PDK 53) in Ten American Volunteers

Vaccine. 1996 Mar;14(4):329-36. doi: 10.1016/0264-410x(95)00167-y.

Abstract

A live-attenuated dengue 2 vaccine (strain 16681 PDK 53) developed at Mahidol University, Thailand was evaluated for safety and immunogenicity by administering 10(4) p.f.u. subcutaneously to ten flavivirus non-immune American volunteers. The vaccine was safe; there were no serious adverse reactions. Eight recipients experienced no or mild side effects. One recipient reported headaches on 7 separate days. One volunteer, who had a fracture of the humerus 1 day after vaccination requiring surgical repair, experienced generalized malaise with fever (maximum temperature = 38.9 degrees C), headache, eye pain and myalgia lasting less than 24 h. The vaccine was highly immunogenic; all recipients developed neutralizing antibody that persisted for two years.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / biosynthesis
  • Cytotoxicity, Immunologic / drug effects
  • Dengue Virus / immunology*
  • Dengue Virus / physiology
  • Female
  • Humans
  • Immunoglobulin M / biosynthesis
  • Lymphocyte Activation / drug effects
  • Lymphocyte Activation / immunology
  • Male
  • T-Lymphocytes / drug effects
  • T-Lymphocytes / immunology
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology
  • Vaccines, Attenuated / pharmacology
  • Viral Vaccines / immunology*
  • Viral Vaccines / pharmacology*
  • Virus Replication / drug effects

Substances

  • Antibodies, Viral
  • Immunoglobulin M
  • Vaccines, Attenuated
  • Viral Vaccines