Prevention of tick-borne encephalitis by FSME-IMMUN® vaccines: Review of a clinical development programme

Loew-Baselli, Alexandra; Poellabauer, Eva Maria; Pavlova, Borislava G.; Fritsch, Sandor; Firth, Clair L.; Petermann, Robert; Barrett, Perry; Ehrlich, Hartmut J.

doi:10.1016/j.vaccine.2011.07.089

Cited by 67 publications

(48 citation statements)

References 43 publications

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“…However, as we concluded previously with RepliVax prototype vaccines (19), mice are not an optimal model for such a comparison because they are exceptionally responsive to flavivirus INVs. It is known that TBE immunity wanes relatively quickly after INV immunization of humans (29). Thus, a key finding in this study was that high N Ab titers were maintained in monkey sera after a single i.d.…”

Section: Discussionmentioning

confidence: 56%

Single-dose vaccine against tick-borne encephalitis

Rumyantsev¹,

Goncalvez²,

Giel–Moloney³

et al. 2013

Proc. Natl. Acad. Sci. U.S.A.

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Tick-borne encephalitis (TBE) virus is the most important human pathogen transmitted by ticks in Eurasia. Inactivated vaccines are available but require multiple doses and frequent boosters to induce and maintain immunity. Thus far, the goal of developing a safe, live attenuated vaccine effective after a single dose has remained elusive. Here we used a replication-defective (single-cycle) flavivirus platform, RepliVax, to generate a safe, single-dose TBE vaccine. Several RepliVax-TBE candidates attenuated by a deletion in the capsid gene were constructed using different flavivirus backbones containing the envelope genes of TBE virus. RepliVax-TBE based on a West Nile virus backbone (RV-WN/TBE) grew more efficiently in helper cells than candidates based on Langat E5, TBE, and yellow fever 17D backbones, and was found to be highly immunogenic and efficacious in mice. Live chimeric yellow fever 17D/TBE, Dengue 2/TBE, and Langat E5/TBE candidates were also constructed but were found to be underattenuated. RV-WN/TBE was demonstrated to be highly immunogenic in Rhesus macaques after a single dose, inducing a significantly more durable humoral immune response compared with three doses of a licensed, adjuvanted human inactivated vaccine. Its immunogenicity was not significantly affected by preexisting immunity against WN. Immunized monkeys were protected from a stringent surrogate challenge. These results support the identification of a single-cycle TBE vaccine with a superior product profile to existing inactivated vaccines, which could lead to improved vaccine coverage and control of the disease.flavivirus vaccine | prophylaxis | preclinical | nonhuman primate

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Section: Discussionmentioning

confidence: 56%

Single-dose vaccine against tick-borne encephalitis

Rumyantsev¹,

Goncalvez²,

Giel–Moloney³

et al. 2013

Proc. Natl. Acad. Sci. U.S.A.

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“…[3][4][5][6] Despite strong evidence that TBE vaccines protect children and adolescents against clinical TBE, vaccine formulations and immunization strategies capable of ensuring optimal protection of the pediatric population combined with an acceptable tolerability profile are under continuous evaluation. 7 In Europe, two pediatric TBE vaccines are currently available on the market: FSME-IMMUN ® Junior (Baxter AG),…”

Section: Introductionmentioning

confidence: 99%

Antibody persistence after two vaccinations with either FSME-IMMUN® Junior or ENCEPUR® Children followed by third vaccination with FSME-IMMUN® Junior

Prymula

Pöllabauer

Pavlova

et al. 2012

Human Vaccines & Immunotherapeutics

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“…More extensive clinical data are available for inactivated, whole-virus vaccines to prevent diseases caused by flaviviruses, which structurally resemble alphaviruses, such as tick-borne encephalitis virus (TBEV), Japanese encephalitis virus, and yellow fever virus (21)(22)(23). The most extensively studied flavivirus vaccine is an alumadjuvanted inactivated whole-virus TBEV vaccine, which has been demonstrated to be safe and immunogenic in a multitude of clinical studies (24)(25)(26)(27)(28)(29)(30) and which has been used in Europe for several decades. In field studies, it has been demonstrated that three immunizations with a 2.4-g dose of the inactivated wholevirus TBEV vaccine provide approximately 99% effectiveness in preventing tick-borne encephalitis (22).…”

Section: Discussionmentioning

confidence: 99%