Clinical responses to smallpox vaccine in vaccinia-naive and previously vaccinated populations: undiluted and diluted Lancy-Vaxina vaccine in a single-blind, randomized, prospective trial

J Infect Dis. 2005 Sep 15;192(6):1066-70. doi: 10.1086/432765. Epub 2005 Aug 11.

Abstract

We conducted a single-blind, randomized trial of 2 dilutions (1:1 or 1:10) of Lancy-Vaxina vaccine (Berna Biotech) in vaccinia-naive persons (n=36) and persons previously vaccinated >25 years ago (n=76). All vaccinees responded successfully to the vaccination. There were no significant differences in the size of the skin lesions, the number of adverse events, the amount of viral shedding, or the level of antibody responses between the undiluted (n=56) and diluted (n = 56) vaccine groups. Compared with vaccinia-naive persons, previously vaccinated persons exhibited significantly smaller and more rapidly evolving skin lesions and fewer adverse events. Previously vaccinated persons had significantly higher neutralizing antibody levels before the administration of the study vaccine than vaccinia-naive persons, and viral shedding from lesions in previously vaccinated persons was lower and diminished more rapidly than from lesions in vaccinia-naive persons.

Publication types

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

MeSH terms

  • Adult
  • Antibodies, Viral / blood
  • Female
  • Humans
  • Immunization, Secondary
  • Male
  • Neutralization Tests
  • Single-Blind Method
  • Skin / pathology
  • Smallpox Vaccine / administration & dosage*
  • Smallpox Vaccine / adverse effects
  • Smallpox Vaccine / immunology*
  • Vaccination
  • Vaccinia virus / immunology
  • Vaccinia virus / isolation & purification
  • Virus Shedding

Substances

  • Antibodies, Viral
  • Smallpox Vaccine