Safety and immunogenicity of the modified adult tick-borne encephalitis vaccine FSME-IMMUN®: Results of two large phase 3 clinical studies

Serological response to tick-borne encephalitis (TBE) vaccination in the elderly – results from an observational study

“…Because the antibody concentrations obtained with the immunoassays used in this study differed between heterologous and homologous vaccines by a factor of approximately 2, the difference between vaccines seen in the overall analysis of data obtained with the Immunozym assay is only partly due to the assay and appears to reflect a true difference between vaccines. Our results differ from those of a prospective, randomized, single-blind Phase III study in a younger population of 3966 healthy volunteers 16 -65 years of age, which demonstrated similar seroconversion rates determined by ELISA or NT after three doses of either FSME-IMMUN or Encepur [9]. The reasons for the significant differences in antibody concentrations and response rates in our investigation are speculative.…”

“…Both vaccines are produced in chicken embryo cells and contain purified, formaldehyde-inactivated TBE virus. FSME-IMMUN contains 2.4 μg of inactivated TBE antigen (virus strain Neudörfl), which has been confirmed in adults 16 -65 years of age to be the optimal antigen concentration with respect to seroconversion and safety profile [8,9]. Encepur contains inactivated 1.5 μg TBE antigen (strain Karlsruhe; K23) [10].…”

An Inactivated Ross River Virus Vaccine Is Well Tolerated and Immunogenic in an Adult Population in a Randomized Phase 3 Trial

“…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).…”

Epidemiological and Ecological Studies of Tick-borne Encephalitis Virus

“…The seroconversion rate has been shown in clinical trials to be close to 100% for adults (16 -65 years) [202,203], and children (< 16 years) after 3 doses of FSME-IMMUN [204,205], and equal seroconversion rates has been reported in children (< 12 years) and adults vaccinated with the Encepur vaccine [206,207]. The FSME-IMMUN and Encepur vaccines are interchangeable and doses of either vaccine can successfully be followed by the other [208].…”