[Duration of protection after BCG vaccination with the 1331 Copenhagen strain (author's transl)]. / Dauer des Impfschutzes nach BCG-Impfungen mit dem Stamm 1331 Kopenhagen.

Children vaccinated in 1975 with different doses of BCG were tested when they were 2 1/2 years old by means of the tine test or, if negative, the tuberculin test at 1 : 100. Of those children who, according to present-day view, had been satisfactorily immunised, 34 of 42 still showed a tuberculin allergy after 2 1/2 years, of those unsatisfactorily vaccinated only 23 of 38. In addition it was found that, contrary to general teaching, positive tuberculin allergy is possible even without scar after a BCG vaccination with the Copenhagen strain (6 of 13). The need of revaccination of tuberculin-negative persons is stressed.

[Investigations carried out to ascertain the dose-effect relationship of a BCG vaccine, strain 1331 Copenhagen, in neonates and young infants (author's transl)]. / Untersuchungen zur Ermittlung der Dosis-Wirkungsbeziehung eines BCG-Impfstoffes, Stamm 1331 Kopenhagen, bei der Neugeborenen- und Säuglingsimpfung.

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.

[Dose-activity relationships of the BCG vaccine for newborn infants (author's transl)]. / Dosis-Wirkungs-Beziehung des BCG-Impfstoffes für Neugeborene. Untersuchungen über den Stamm 13 31 Kopenhagen

BCG vaccine with the Kopenhagen strain was injected intracutaneously in 217 newborn infants in four different concentrations (22.000, 50.000, 110.000, and 160.000 organisms per dose). 171 children could be followed up and tested. The results showed a good activity (tuberculin conversion) with a low risk (no ulcers, no severe regional lymph node swelling). There were no complications. As would be expected the conversion rate was highest (95%) with the vaccine with the highest concentration (160.000 U per dose). This concentration is thus recommended for the general BCG vaccination of newborn infants. In contrast to previous experience tuberculin conversion could be demonstrated in 22 babies without a local reaction at the vaccination site. In 13 children the opposite was true.