Active clinical trials for "Encephalitis, Tick-Borne"

In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis. Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.

Tick-borne Encephalitis (TBE) can be prevented by vaccine. Vaccine failure, defined as a case of TBE regardless of previous vaccination, has been described and seems to be more predominant with increasing age, suggesting a less effective immune response following with increasing age. In fact previous studies has shown a reduced antibody response in elderly individuals compared to younger when vaccinated against TBE. As a result, in Sweden, an extra vaccine dose has been recommended during the primary vaccine schedule to individuals > 50 years of age. This alternative vaccine schedule has not been tested. The investigator aim to test if an extra vaccine dose in the primary vaccine schedule for those > 50 years of age improves the immune response and offers a corresponding immunity to younger individuals following TBE vaccination.

Tick-borne encephalitis (TBE) is a zoonosis mainly transmitted to humans by the bite of ticks of the genus Ixodes and, to a lesser extent, by the consumption of contaminated and unpasteurized dairy products. During the last decade, the epidemiology of this arbovirosis has changed profoundly with the discovery of new human cases and/or new areas of circulation of tick-borne encephalitis virus (TBEV) throughout Europe and particularly in France. Historically, Alsace is the main endemic area for this pathology in France. The pathology is notifiable since June 2021 in France. Although TBEV infection in children seems to lead to a milder clinical presentation, data are much less abundant than in adults and only a few cases reported in infants under 1 year old have been published. Data from the most recent ECDC Annual Epidemiological Report on TBE (2019) showed incidence rates of approximately 0.2 and 0.5 per 100,000 population in patients younger than 5 and 15 years, respectively. However, several observations may moderate and challenge both the low incidence rate and the less severe clinical presentation reported in children

Cases of encephalitis of varying severity have been described in recent years in eastern France involving tick-borne encephalitis virus (TBEV). The main objective is to demonstrate the presence of TBEV in Limousin, in patients with a positive Lyme serology, or a neurological picture compatible with TBEV.

During 2018, 2019, and 2020, the reported TBE-cases have increased markedly in Norway. Surveillance studies conducted by the Norwegian Institute of Public Health demonstrate that cases are associated with tick bites in the coastal areas of the Agder, Buskerud, and Vestfold and Telemark counties There is a urgent need for more knowledge of the consequences of TBE in Norway, in particular the identification of patients at risk of long-term sequela. Hence, the overall objective of this project is to gain more knowledge about the natural course of TBE in Norway, and its impact on long-term health-related quality of life and associated factors. Clinical data, biological sampling and PROMs are collected from TBE-infected patients admitted to three hospitals within the epidemic region in Norway.

This was an open label trial of a non-US licensed vaccine for tick-borne encephalitis. The vaccine was licensed by Baxter, and now following an acquisition by Pfizer Inc in Vienna, Austria since 2001, and has an extensive safety record in multiple European countries. Field effectiveness studies suggest > 99 percent protection against disease transmitted by the natural routes of either tick bite or ingestion of contaminated, unpasteurized milk. The vaccine is also considered to be effective against laboratory exposures and is used routinely for this purpose in European laboratories. The US Centers for Disease Control and Prevention and the National Institutes of Health acknowledge the effectiveness of the vaccine by allowing those who have received it to study tick-borne encephalitis virus (TBEV) in isolation facilities rated at BSL-3 rather than the more stringent BSL-4, with the exception of the Russian Spring-Summer Encephalitis strain. Subjects were recruited from personnel at 2 intramural campuses of the National Institute of Allergy and Infectious Diseases who may be exposed accidentally to any strain or serotype of viable TBEV. Approximately 160 individuals were eligible to participate. The rapid immunization schedule (injections on Days 0, 14, and 161) was used and subjects had labs drawn 21 days after the 2nd, 3rd and 4th vaccine injections to determine seroconversion. Subjects that seroconverted to TBEV were offered a booster dose of the vaccine 3 years from the date of receipt of the third dose of the vaccine. Subjects that were seropositive at entry into the study were offered a booster dose of the vaccine every 3 years from Day 0.

This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Many viral infections of global importance, including HIV, are transmitted across the mucosal surface of the genital tract. As immunity against these infections is likely to be primarily mediated by antibodies in mucosal secretions, developing techniques to increase the levels and persistence of antiviral antibody on mucosal surfaces may enhance the protection against a number of important infections. Preclinical studies have anatomically targeted vaccine antigens to sites where genital tract immunity is induced. This response is likely due to the ability of regional lymph Preclinical studies have anatomically targeted vaccine antigens to sites where genital tract immunity is induced. This response is likely due to the ability of regional lymph nodes to "pattern" the cell surface markers of responding vaccine specific lymphocytes with homing markers. In contrast, injecting a distant muscle (such as in the arm) which shares no anatomical relationship with the vagina, may not pattern cells with homing markers for the genital tract. Direct injection of inguinal lymph nodes is impractical in humans but intramuscular injection into the thigh will target antigens to the deep inguinal lymph nodes shared in common with the cervix/vagina. This study will be a Phase IV randomised, single centre, open label, laboratory assessment blinded exploratory trial to assess mucosal immunogenicity following three targeted intramuscular immunisations with TicoVac vaccine. 20 subjects will be randomised to each of2 groups immunised in right deltoid or right anterolateral thigh. Following an initial screening visit subjects will be immunised at 0, 1 and 6 months. There will be follow up visits 5 days after each immunisation and a final visit at 7 months. Blood samples and cervicovaginal secretions will be taken prior to each immunisation for immunological measures. In addition, blood samples will be taken at each immunisation and follow up visit for measurement of peripheral blood mononuclear cells. The study is funded by ADITEC, which is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

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 rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.