Five year follow-up after primary vaccination against tick-borne encephalitis in children.
BACKGROUND
A first tick-borne encephalitis (TBE) vaccine booster in children is currently suggested 3 years after completing either a conventional (doses on Days 0, 28 and 300) or accelerated conventional (doses on Days 0, 14 and 300) TBE immunization schedule. This recommendation, however, may not be appropriate in cases where different TBE vaccines have been used interchangeably during the primary immunization series.


METHODS
To provide robust data to better inform such recommendations, TBE antibody persistence was evaluated after 3-5 years in four groups of children (aged 5-15 years): two groups previously primed with three doses of Encepur(®) Children (conventional/accelerated conventional schedule); and two groups previously primed with two doses of FSME-IMMUN(®) followed by a third dose of Encepur(®) Children (conventional/accelerated conventional schedule). Immunogenicity was evaluated using neutralization (NT) assays based on both vaccine antigens as well as on the Enzyme Linked Immunosorbent Assay (ELISA).


RESULTS
In the two Encepur(®) Children groups (full series), protective NT titers of ≥10 were detected in 98-100% of children up to 5 years after their last primary vaccination, irrespective of schedule. In contrast, only 65-70% subjects in the FSME-IMMUN(®) Junior groups (mixed series) displayed NT titers ≥10 after 3 years. Thus, due to lower probability of achieving/maintaining long-term protective antibody levels (recently defined by the World Health Organization as an NT titer ≥10) after this time point, both FSME-IMMUN Junior groups were discontinued.


CONCLUSIONS
A strong antibody response persists for at least 5 years after full primary vaccination with Encepur(®) Children. The study thus provides support for extending the time interval for a first booster dose after primary vaccination (conventional/accelerated conventional schedule) with Encepur(®) Children from 3 to 5 years.
Am Bachlanger 3, D-82362 Weilheim, Germany.
Christoph
C
Wittermann
Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, USA.
Allen
A
Izu
Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.
Eckhardt
E
Petri
Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.
Dieter
D
Gniel
Novartis Vaccines and Diagnostics, Srl., Siena, Italy. Electronic address: elena.fragapane@novartis.com.
Elena
E
Fragapane
D000293:Adolescent; D057134:Antibodies, Neutralizing / Q000097:blood*; D000914:Antibodies, Viral / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D004669:Encephalitis Viruses, Tick-Borne / Q000276:immunology*; D004675:Encephalitis, Tick-Borne / Q000517:prevention & control*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D008297:Male; D009500:Neutralization Tests; D014611:Vaccination; D014765:Viral Vaccines / Q000008:administration & dosage / Q000276:immunology*; D014944:World Health Organization
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; C464914:Encepur; D014765:Viral Vaccines
Immunogenicity; Pediatric; Persistence; Primary vaccination; TBE; Tick-borne encephalitis