Prevention of tick-borne encephalitis by FSME-IMMUN(®) vaccines: Review of a clinical development programme.
Summary of "Prevention of tick-borne encephalitis by FSME-IMMUN(®) vaccines: Review of a clinical development programme."
The need for highly effective tick-borne encephalitis (TBE) vaccines has increased globally due to a variety of factors including climate, social, economic and demographic changes, which are thought to have promoted the expansion of the endemic region of TBE viruses. The first TBE vaccine, FSME-IMMUN(®) Inject, was introduced in the 1970s and has been continually improved since then to enhance both its safety and immunogenicity. The current formulation was established in 2001 and is marketed as FSME-IMMUN(®). This review summarizes findings of the clinical development programme since 2001 regarding determination of the optimal dose, conventional and rapid vaccination schedules, vaccination in adults, the elderly and special patient populations, safety, immunogenicity, and immunopersistence in adults and children, comparison of FSME-IMMUN(®) with another commercially available TBE vaccine as well as post-marketing vaccination outcome. This successful research programme demonstrated the strong immunogenicity and continued safety of the FSME-IMMUN(®) vaccine, which is further confirmed by the performance reported under field conditions.
Affiliation
Global R&D, Baxter BioScience, Wagramer Str. 17-19, A-1221 Vienna, Austria.
Journal Details
This article was published in the following journal.
Name: Vaccine
ISSN: 1873-2518
Pages: 7307-19
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21843576
- DOI: http://dx.doi.org/10.1016/j.vaccine.2011.07.089
Medical and Biotech [MESH] Definitions
Encephalitis, Tick-borne
Encephalitis caused by neurotropic viruses that are transmitted via the bite of TICKS. In Europe, the diseases are caused by ENCEPHALITIS VIRUSES, TICK-BORNE, which give rise to Russian spring-summer encephalitis, central European encephalitis, louping ill encephalitis, and related disorders. Powassan encephalitis occurs in North America and Russia and is caused by the Powassan virus. ASEPTIC MENINGITIS and rarely encephalitis may complicate COLORADO TICK FEVER which is endemic to mountainous regions of the western United States. (From Joynt, Clinical Neurology, 1996, Ch26, pp14-5)
Ixodes
The largest genus of TICKS in the family IXODIDAE, containing over 200 species. Many infest humans and other mammals and several are vectors of diseases such as LYME DISEASE, tick-borne encephalitis (ENCEPHALITIS, TICK-BORNE), and KYASANUR FOREST DISEASE.
Encephalitis Viruses, Tick-borne
A subgroup of the genus FLAVIVIRUS that causes encephalitis and hemorrhagic fevers and is found in eastern and western Europe and the former Soviet Union. It is transmitted by TICKS and there is an associated milk-borne transmission from viremic cattle, goats, and sheep.
Japanese Encephalitis Vaccines
Vaccines or candidate vaccines used to prevent infection with Japanese B encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE).
Tick Control
Chemical, biological, or medical measures designed to prevent the spread of ticks or the concomitant infestations which result in tick-borne diseases. It includes the veterinary as well as the public health aspects of tick and mite control.
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Clinical Trials
The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rap...
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW...
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the fi...
The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with...
TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
The purpose of this study is to assess: - TBE antibody persistence 24, 34, 46 and 58 months (as applicable) after the first booster TBE vaccination with FSME-IMMUN 0.5ml given in...
