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[BCG vaccination of the newborn infant with the 131 Copenhagen strain]
Insights
BCG vaccination in infants showed a 0.3% complication rate for suppurating regional lymphadenitis. The study confirmed high tuberculin conversion rates, indicating vaccine effectiveness, with some dependence on vaccine concentration.
Area of Science:
- Pediatrics
- Immunology
- Public Health
Context:
- Prospective study conducted from October 1, 1979, to September 30, 1981.
- Focus on side-effects of Bacillus Calmette-Guérin (BCG) inoculation in infants.
- Collaboration with pediatricians, public health authorities, and obstetric departments in Duisburg, Essen, and Mülheim.
Purpose:
- To evaluate the side-effects of BCG inoculation, specifically suppurating regional lymphadenitis.
- To assess the tuberculin conversion ratio following BCG vaccination.
- To investigate the relationship between vaccine concentration and outcomes.
Summary:
- 21,294 infants (89% of live births) received BCG vaccination using the Copenhagen 1331 strain.
- A complication rate of 0.3% was observed for suppurating regional lymphadenitis (66 cases).
- High tuberculin conversion rates were documented: 84% positive on initial test, 98.4% positive after a second test if needed.
Impact:
- The study demonstrates a low incidence of serious side-effects from BCG vaccination.
- High conversion rates indicate BCG's efficacy in inducing tuberculin-positive reactions.
- Vaccine concentration influences both conversion rates and local ulceration incidence.
Abstract:
From October 1, 1979 to September 30, 1981 a prospective study on the side-effects of BCG inoculation was conducted in the cities of Duisburg, Essen, and Mülheim, in very close cooperation with practising pediatricians, public health authorities, and obstetric departments. Particular consideration was given to suppurating regional lymphadenitis. In the period covered by the study 21.294 infants from 23.390 live births (i.e., 89%) were BCG-vaccinated using the Copenhagen 1331 strain manufactured by Behringwerke. A suppurating regional lymphadenitis occurred in 66 cases, i.e., a complication rate of 0.3%. The conversion ratio was high. Out of 8.144 documentation forms that could be assessed 6.840 (84%) attested to a positive tuberculin reaction caused by prophylactic test U 4. If the result of this test was negative a second test, after Mendel-Mantoux, strength 10, was used. According to this a total of 7.311, i.e., altogether 98.4% of the inoculation results evaluated, were positive. Both the conversion ratio as well as the incidence of ulcers at the vaccination site depend to a slight degree on the concentration of units in the vaccine which are capable of reproduction, to the extent that at higher concentrations the conversion ratio increases, as does the number of ulcers at the vaccination site.