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[Dose-activity relationships of the BCG vaccine for newborn infants (author's transl)]
Insights
The Kopenhagen strain BCG vaccine showed good efficacy and low risk in newborns. The highest concentration (160,000 organisms) is recommended for infant BCG vaccination due to a 95% tuberculin conversion rate.
Area of Science:
- Immunology
- Pediatrics
- Vaccinology
Background:
- Bacille Calmette-Guérin (BCG) vaccination is crucial for preventing tuberculosis (TB) in infants.
- Optimizing BCG vaccine concentration is essential for maximizing efficacy while minimizing adverse reactions.
Purpose of the Study:
- To evaluate the safety and efficacy of the Kopenhagen strain BCG vaccine at different concentrations in newborn infants.
- To determine the optimal BCG vaccine concentration for infant immunization.
Main Methods:
- Intracutaneous administration of BCG vaccine (Kopenhagen strain) at four concentrations (22,000–160,000 organisms/dose) to 217 newborns.
- Follow-up and tuberculin testing of 171 infants to assess BCG vaccine activity.
- Monitoring for local and regional adverse reactions.
Main Results:
- High tuberculin conversion rates (up to 95%) were observed, indicating good BCG vaccine efficacy.
- The highest concentration (160,000 organisms/dose) demonstrated the highest conversion rate.
- The vaccine exhibited a low risk profile, with no reported ulcers or severe lymph node swelling.
Conclusions:
- The Kopenhagen strain BCG vaccine is safe and effective for newborn immunization.
- A concentration of 160,000 organisms per dose is recommended for general BCG vaccination of infants.
- Tuberculin conversion can occur without local reactions, challenging previous observations.
Abstract:
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.