[Investigations carried out to ascertain the dose-effect relationship of a BCG vaccine, strain 1331 Copenhagen, in neonates and young infants (author's transl)].

1405 neonates and infants were vaccinated with BCG Vaccine (strain 1331 Copenhagen) at five clinics in the Federal Republic of Germany. Doses in logarithmic increments from 22000 to 250000 VU (viable units)/0.1 ml were given by strictly intradermal injection. Carrying out the post-vaccinal tuberculin test by the MENDEL-MANTOUX technique, the dose-effect relationship could be demonstrated (Fig. 3). Conversion rates raised from 43% to 76% (Tab. 1); they are furthermore depending from the tuberculin dose and the assessment of the skin reaction. Tests with up to 50 I.U. of purified tuberculin were resulting in conversion rates over 90% for vaccination doses of 100 000 VU and more, any palpable infiltration regarding as a positive result (Fig. 4). The vaccine showed good safety in all concentrations employed concerning reactions at the site of injection. Lympnode enlargement, palable even 12 weeks postvacc., was common. In the course of the trial there was one case of suppurative lymphadenitis among the 262 children who were given the vaccine in the highest concentration (250000 VU). Subsequent trials revealed a rate of this complication in the 1:1000 range. The approval for the vaccine with 100000-300000 VU/dose has subsequently been given by the Federal Bureau for Sera and Vaccines.