Protective efficacy of a live attenuated vaccine against Argentine hemorrhagic fever. AHF Study Group

J Infect Dis. 1998 Feb;177(2):277-83. doi: 10.1086/514211.

Abstract

Argentine hemorrhagic fever (AHF), caused by the arenavirus Junin, is a major public health problem among agricultural workers in Argentina. A prospective, randomized, double-blind, placebo-controlled, efficacy trial of Candid 1, a live attenuated Junin virus vaccine, was conducted over two consecutive epidemic seasons among 6500 male agricultural workers in the AHF-endemic region. Twenty-three men developed laboratory-confirmed AHF during the study; 22 received placebo and 1 received vaccine (vaccine efficacy 95%; 95% confidence interval [CI], 82%-99%). Three additional subjects in each group developed laboratory-confirmed Junin virus infection associated with mild illnesses that did not fulfill the clinical case definition for AHF, yielding a protective efficacy for prevention of any illness associated with Junin virus infection of 84% (95% CI, 60%-94%). No serious adverse events were attributed to vaccination. Candid 1, the first vaccine for the prevention of illness caused by an arenavirus, is safe and highly efficacious.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Agricultural Workers' Diseases / prevention & control
  • Agricultural Workers' Diseases / therapy
  • Agricultural Workers' Diseases / virology
  • Animals
  • Antibodies, Viral / analysis
  • Antibodies, Viral / immunology
  • Arenaviruses, New World / growth & development
  • Arenaviruses, New World / immunology*
  • Argentina
  • Cells, Cultured
  • Chlorocebus aethiops
  • Double-Blind Method
  • Hemorrhagic Fever, American / diagnosis
  • Hemorrhagic Fever, American / prevention & control*
  • Hemorrhagic Fever, American / therapy*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Seasons
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / therapeutic use*
  • Vero Cells
  • Viral Vaccines / adverse effects
  • Viral Vaccines / therapeutic use*

Substances

  • Antibodies, Viral
  • Vaccines, Attenuated
  • Viral Vaccines