Infant BCG vaccination study in Lithuania

SETTING: infants identified in maternity hospitals in Vilnius, Lithuania. OBJECTIVES: To test the capacity of the BCG vaccine, Danish strain 1331 (Da nish vaccine), to induce tuberculin reactivity and scar formation in neonat es compared to the WHO International Reference Preparation of BCG (TRP vacc ine), and to study the effect of dose and of age at vaccination. DESIGN: A randomized four-armed study: 1) normal dose, 0.05 ml Danish vacci ne given to neonates at birth, 2) half the normal dose of Danish vaccine gi ven at birth, 3) IRP vaccine given at birth at normal infant dose, and 4) t he normal infant dose of Danish vaccine given at 3 months of age. RESULTS: Larger tuberculin reactions, as well as an increased frequency and larger scars, were seen when Danish vaccine was given at 3 months of age i n comparison to neonatal vaccination. Halving the dose resulted in smaller reactions, but the difference was not significant. The IRP vaccine resulted in borderline significantly larger reactions in comparison to the Danish v accine. The number of infants receiving very early vaccination (0-2 days) w as not evenly distributed in all groups, however, which is believed to expl ain the observed difference.