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Tick-Borne Encephalitis clinical trials

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NCT ID: NCT01710189 Completed - Clinical trials for Tick-Borne Encephalitis

Cervicovaginal Immune Responses to 3 Deltoid or Thigh Intramuscular (IM) TicoVac

CRC306
Start date: October 2012
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01562444 Completed - Virus Diseases Clinical Trials

Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

Start date: March 8, 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate the immunogenicity response in adults up to 10 years after one booster dose. Data collected from this study will allow for greater information to prescribers who administer TBE vaccine, so that they can appropriately time the administration of booster vaccinations to individuals who received different vaccination schedules and who live in tick borne encephalitis endemic regions.

NCT ID: NCT01361776 Completed - Clinical trials for Tick-borne Encephalitis

Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

Start date: September 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Antibody titers after tick-borne encephalitis (TBE) vaccination are less in elderly and vaccination breakthroughs are more common in this age group. This has prompted Swedish authorities to recommend an additional dose in the initial vaccination schedule (= 0+30+90 days instead of the usually recommended 0+30 days. The investigators intend to evaluate this regime.

NCT ID: NCT01031537 Terminated - Clinical trials for Encephalitis, Tick-Borne

Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)

TBEV
Start date: September 25, 2009
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00890422 Active, not recruiting - Clinical trials for Tick Borne Encephalitis

Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine

immunisation
Start date: March 2007
Phase: Phase 2
Study type: Interventional

The study aims to answer this question: whether adequate immunity can be achieved in a short time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation schedules? The investigators will test the immunogenicity (the degree of immunity achieved) of each of the immunisation schedules at various times after the injections. If the results of this clinical study are positive, it may then be possible to develop the most successful immunisation schedule so that it can be used routinely. This means that the results of the clinical study have an enormous practical value in preventing TBE in people travelling or moving into areas with a high TBE risk.

NCT ID: NCT00804219 Completed - Clinical trials for Tick-borne Encephalitis

Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination

Start date: December 2008
Phase: Phase 4
Study type: Interventional

The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees. The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.

NCT ID: NCT00161863 Completed - Clinical trials for Tick-borne Encephalitis

Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Start date: September 2002
Phase: Phase 3
Study type: Interventional

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 first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.

NCT ID: NCT00161798 Completed - Clinical trials for Tick-borne Encephalitis

Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

Start date: September 2001
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.

NCT ID: NCT00161785 Completed - Clinical trials for Tick-borne Encephalitis

Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME-IMMUN 0.5 ml in Adults Aged 18 - 67 Years

Start date: June 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess: - TBE antibody persistence 2 and 3 years after the third TBE vaccination with FSME-IMMUN 0.5ml by means of ELISA and neutralization test (NT). - TBE antibody response to a booster vaccination with FSME-IMMUN 0.5ml, by means of ELISA and NT.

NCT ID: NCT00161772 Completed - Clinical trials for Tick-borne Encephalitis

Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.

Start date: March 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.