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Published on: September 19, 2016
Tick-borne encephalitis: development of a paediatric vaccine. A controlled, randomized, double-blind and multicentre
1Behringwerke AG, Marburg, Germany.
Vaccine
|October 1, 1996
Summary
Reduced antigen doses in tick-borne encephalitis (TBE) vaccination for children maintain antibody response while significantly lowering fever and side effects. This optimized TBE vaccine schedule offers improved safety and comparable efficacy in pediatric populations.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Tick-borne encephalitis (TBE) is a serious viral infection with significant neurological impact.
- Current TBE vaccination schedules aim for high efficacy but can be associated with side effects, particularly in children.
- Optimizing vaccine antigen load is crucial for balancing immunogenicity and tolerability.
Purpose of the Study:
- To evaluate the immunogenicity and safety of reduced antigen doses of TBE vaccine in children.
- To compare antibody responses in children receiving lower TBE vaccine doses with those in adults receiving the standard dose.
- To assess the reduction in side effects, such as fever, with decreased antigen levels.
Main Methods:
- A total of 522 children (18 months–14 years) and 191 adults (18–60 years) received TBE vaccine on an abbreviated schedule (0, 7, 21 days).
- Children were vaccinated with reduced antigen doses (0.4 µg or 0.75 µg), while adults received the standard 1.5 µg dose.
- Antibody titers were measured to determine immune response equivalence, and the frequency of side effects (e.g., fever >38°C) was recorded.
Main Results:
- Children vaccinated with lower TBE antigen doses achieved antibody titers equivalent to adults receiving the standard dose.
- A significant reduction in the incidence of fever (>38°C) was observed in children receiving lower doses (18.8% and 18.4%) compared to the standard dose (30.1%).
- Improved tolerance was noted, with fewer general reactions like tiredness, joint pain, and headache in the reduced-dose groups.
Conclusions:
- Reduced antigen doses of TBE vaccine are immunogenically equivalent to the standard dose in children.
- Lower antigen doses significantly improve the tolerability of TBE vaccination in pediatric populations by reducing fever and other side effects.
- This study supports the use of optimized TBE vaccine antigen loads for enhanced pediatric safety without compromising efficacy.
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