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Published on: September 23, 2022
Antibody response following administration of two paediatric tick-borne encephalitis vaccines using two different
Christoph Wittermann1, I Schöndorf, D Gniel
1Am Bachlanger 3, D-82362, Weilheim, Germany. CHWittermann@aol.com
Insights
Encepur Children demonstrated superior immunogenicity compared to FSME-IMMUN Junior in children for tick-borne encephalitis. Encepur Children also effectively completed primary vaccination courses initiated with FSME-IMMUN Junior.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Immunology
Background:
- Two pediatric tick-borne encephalitis (TBE) vaccines, Encepur Children and FSME-IMMUN Junior, are widely used in Europe.
- Understanding their comparative immunogenicity and safety is crucial for public health.
Purpose of the Study:
- To compare the immunogenicity and safety of Encepur Children and FSME-IMMUN Junior in children.
- To evaluate TBE vaccine schedules and the efficacy of Encepur Children in completing a primary vaccination course initiated with FSME-IMMUN Junior.
Main Methods:
- Phase IV randomized, controlled, single-blind, multi-centre trial involving 334 children aged 1 to <11 years.
- Vaccines administered on conventional (Days 0, 28, 300) or accelerated (Days 0, 14, 300) schedules.
- Antibody titres assessed by neutralization test (NT); local and systemic reactions monitored.
Main Results:
- Encepur Children showed a higher proportion of subjects achieving NT > or = 10 compared to FSME-IMMUN Junior at Days 42 and 300 across both schedules (P<0.001).
- A third dose of Encepur Children significantly increased NT > or = 10 in subjects initially vaccinated with FSME-IMMUN Junior.
- >95% of all children achieved protective NT titres (> or = 10) after the primary vaccination course.
Conclusions:
- Encepur Children elicits a superior immune response (neutralizing TBE antibodies) compared to FSME-IMMUN Junior.
- Encepur Children can be effectively used to complete a primary vaccination course initiated with FSME-IMMUN Junior.
- Both vaccines were well-tolerated with comparable safety profiles; no vaccine-related serious adverse events were reported.
Abstract:
Two paediatric tick-borne encephalitis vaccines, Encepur Children and FSME-IMMUN Junior, are used widely in Europe. This study compared the immunogenicity and safety of both vaccines, administered using the conventional (Days 0, 28, and 300) or accelerated (Days 0, 14, and 300) schedule and evaluated whether a third dose of Encepur Children can complete a primary vaccination course initiated with FSME-IMMUN Junior. A total of 334 children 1 to < 11 years of age were enrolled in this Phase IV randomized, controlled, single-blind, multi-centre trial. All subjects, irrespective of study arm, received Encepur Children as the third dose on Day 300. The percentage of subjects with antibody titres > or = 10, as determined by neutralization test (NT), was assessed and local and systemic reactions were monitored and solicited. Within both the conventional and accelerated schedules, the proportion of subjects achieving an NT > or = 10 was higher in the group that received Encepur Children, compared with the group that received FSME-IMMUN Junior, at Days 42 and 300 (conventional schedule Day 300, P < 0.001 Encepur Children versus FSME-IMMUN Junior; accelerated schedule Days 42 and 300, P<0.001 Encepur Children versus FSME-IMMUN Junior). The third dose of Encepur Children led to a substantial increase in the proportion of subjects in the FSME-IMMUN Junior groups achieving NT > or = 10. Overall, >95% of all children achieved NT > or = 10, on completion of the primary vaccination course. Encepur Children provides an immune response, measured by neutralizing TBE antibodies, that is superior to FSME-IMMUN Junior and can successfully be used to complete a primary vaccination course initiated with FSME-IMMUN Junior. Both vaccines were well tolerated, with comparable safety profiles; no vaccine-related serious adverse events were reported.
