Live Oka/Merck varicella vaccine in healthy children. Further clinical and laboratory assessment

JAMA. 1985 Nov 1;254(17):2435-9.

Abstract

A clinical trial among 137 healthy children, ages 1 to 12 years, was conducted with four different doses (4,350, 870, 435, and 43 plaque-forming units [pfu]) of live Oka/Merck varicella vaccine to evaluate clinical reactions and selected laboratory parameters and to determine the minimum effective dose and induction time of antibody. The vaccine was well tolerated with no significant difference in the rate of reported symptoms by dose. The frequency of varicellalike rash was 3% (4/137); all rashes were mild. Serum aminotransferase values were essentially unchanged after vaccination. Minor variations found in platelet counts after vaccination were not associated with any bleeding, bruising, or clotting. Among initially seronegative children who received doses of 435 pfu or greater, 94% assayed at two weeks and 100% assayed at four or six weeks seroconverted. The geometric mean titers were similar for all four doses at six weeks. IgG and IgA responses were demonstrated with no relation to the vaccine dose.

MeSH terms

  • Alanine Transaminase / blood
  • Antibodies, Viral / biosynthesis
  • Aspartate Aminotransferases / blood
  • Chickenpox / etiology
  • Chickenpox Vaccine
  • Child
  • Child, Preschool
  • Female
  • Fever / etiology
  • Follow-Up Studies
  • Herpesvirus 3, Human / immunology
  • Humans
  • Immunoglobulin A / biosynthesis
  • Immunoglobulin G / biosynthesis
  • Infant
  • Male
  • Pain / etiology
  • Platelet Count
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology*
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology*

Substances

  • Antibodies, Viral
  • Chickenpox Vaccine
  • Immunoglobulin A
  • Immunoglobulin G
  • Vaccines, Attenuated
  • Viral Vaccines
  • Aspartate Aminotransferases
  • Alanine Transaminase