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. 2009 Jan 21;2009(1):CD000977. doi: 10.1002/14651858.CD000977.pub2
Vaccine type Specific vaccine Status Year developed (approximate) Components Notes Producer Trials
KKhv Unclear 1985 TBE strain K23 (grown on chick‐embryo cells, formalin inactivated, purified, stabilized with polygeline and adsorbed onto 0.2% alum)
Prepared from the Sofin strain, which is of the Far Eastern TBE subtype
Academy of Medical Sciences, former USSR Popov 1985 (awaiting assessment)
IPVE Unclear 1999 Inactivated, dry, purified concentrated suspension of the Sofin strain
Contains no more than 30 µg of extrinsic protein and aluminium hydroxide gel as solvent
Prepared for use in 1‐dose ampoules (0.5 mL) Chumakov Institute of Poliomyelitis and Viral Encephalitides (IPVE) Pavlova 1999
FSME‐IMMUN FSME‐IMMUN [1976] Not licensed 1976 Neudoerfl strain TBE virus (European subtype) grown in a chick‐embryo cell culture partially purified by hydroxyapatite chromatography and inactivated by formalin with aluminium hydroxide as an adjuvant In Western Europe, First TBE vaccine developed in Western Europe (Kunz 1992)
Reports of adverse effects (headache, malaise, pyrexia) were common
Baxter (Immuno AG)
FSME‐IMMUN [1980] Not licensed 1980 A "highly purified" version consisting of TBE‐virus antigen purified by continuous flow zonal ultracentrifugation (1 µg/dose)
Formaldehyde‐inactivated TBE virus (1 to 3.5 µg) prepared from a "seed virus" cultivated on mouse brain suspension and containing aluminium hydroxide (1 mg) as adjuvant
Stabilized with addition of human seroalbumin (0.5 µg)
Preparation also contained thiomerosal (0.05 mg) as preservative and 0.35 mg of Na‐EDTA as stabilizer
Developed in response to adverse effects with 1976 version
Led to the development of the highly purified version
3 intramuscular doses of 0.5 mL each containing 2 to 3 μg of inactivated TBE virus antigen at 0, 3, and 10 to 13 months, with booster doses recommended every 3 years (Kunz 1992)
Baxter (Immuno AG) Immuno 1996
Pavlova 1999
FSME‐IMMUN [1999] Not licensed 1999 Preparation had same composition of the precedent vaccine (quantity of sugary and buffer solutions were unvaried), but it did not contain conservant thiomerosal and stabilizer Na‐EDTA With the aim to observe the new instructions of the "European Pharmacopoeia" (Council of Europe 1999), this new FSME‐IMMUN vaccine was introduced on the market Baxter (Immuno AG)
TicoVac Not licensed 2000 Concerns of contamination from mouse brain proteins led producers to cultivate seed virus using chick embryo cells instead
First vaccine not to contain human seroalbumin stabilizer and prepared with adjuvant only (aluminium hydroxide)
Formaldehyde‐inactivated prepared with aluminium hydroxide as an adjuvant
TBE virus strain Neudorfl grown on primary chick embryo fibroblasts, purified and concentrated by sucrose density centrifugation
No albumin or thiomersal
Antigen content 2.7 µg target; 2 to 3.5 µg range
High rate of adverse events (eg fever and convulsions in children) meant this vaccine not successful Baxter (Immuno AG) Eder 2003i
Eder 2003ii
FSME‐IMMUN (new) Licensed 2001 Human seroalbumin re‐included in formulation Conventional vaccination schedule consists of 3 doses at birth, 1 to 3 months, and 9 to 12 months after second dose
Rapid immunization schedule involves 2 vaccine doses given 2 or 3 weeks apart (Beran 2004)
Fewer adverse reactions observed
Baxter (Immuno AG) Ehrlich 2003
Loew‐Baselli 2006
  FSME‐IMMUN (Junior) Licensed 2002 Paediatric formulation containing the half dose of all components present in the adult formulation (Barrett 2003) Baxter (Immuno AG)
Encepur Encepur (aged at least 12 years) Not licensed 1991 Contains TBE virus (K23, European subtype) isolated from a tick near Karlsruhe, Germany
Virus grown on primary chick embryo cells, inactivated by formaldehyde, purified with continuous‐flow density gradient centrifugation, adjuvated with aluminium hydroxide and stabilized with polygeline (gelatine + Tris‐EDTA‐buffer, + K glutamate 0.1%)
Chiron‐Behring (now part of Novartis) Bock 1990
Harabacz 1992
Girgsdies 1996
Loew‐Baselli 2006
Encepur K (paediatric formulation) Not licensed 1991 Contains half dose of antigen, excipients, adjuvant of Encepur Many adverse reactions observed in consequence to the high IgE response to the gelatin stabilizer, and Encepur K withdrawn from the market Chiron‐Behring (now part of Novartis)
Encepur adults Licensed Unclear Contains inactivated TBE virus antigen (strain K23, 1.5 µg), aluminium hydroxide (1 mg), formaldehyde (max 5 μg), salts, sucrose, and water
Poligeline free
Each 0.5 mL dose contains 1.5 µg of TBE virus strain K23 formalin inactivated and adjuvanted with 1.0 mg aluminium hydroxide, and sucrose (25 mg) as stabilizer an was intramuscularly administered
Licensed for rapid immunization schedule on days 0, 7, and 21 followed by a fourth dose 12 to 18 months later (Barrett 2003) Novartis Schöndorf 2007
Encepur children Licensed Unclear Contains half the dose of antigen (0.75 µg antigen/0.25 mL dose), excipients, adjuvant compared to the adult preparation
Poligeline free
Licensed for rapid immunization schedule on days 0, 7, and 21 followed by a fourth dose 12 to 18 months later (Barrett 2003) Novartis Schoendorf 2007
Chimeric live‐attenuated vaccines Under study Prepared with the use of a recombinant technique by replacing membrane precursor and envelope structural protein genes of non‐neuroinvasive, mosquito‐borne dengue 4 virus (DEN4) with the corresponding genes of langat virus strain TP21 Wright 2008