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Encephalitis clinical trials

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NCT ID: NCT00545493 Unknown status - Clinical trials for Rasmussen Encephalitis

Efficacy of Tacrolimus and I.V.-Immunoglobulins in Rasmussen Encephalitis

Start date: November 2002
Phase: Phase 2/Phase 3
Study type: Interventional

Rasmussen encephalitis (RE) is a rare but severe chronic inflammatory brain disease of unknown origin affecting one brain hemisphere. It is usually accompanied by intractable epilepsy. In addition, it often leads to severe disability due to functional deficits caused by atrophy of one brain hemisphere. Hemispherectomy is an effective means of surgical treatment of the epilepsy. It renders the patient, however, hemiplegic, hemianopic and (if the language dominant hemisphere is affected) aphasic. To slow down or even stop the progressive inflammatory damage to the affected brain hemisphere, immunotherapies may be beneficial. According to a literature survey, tacrolimus (twice daily intake of capsules) and intravenous immunoglobulins (monthly infusions) are the most promising compounds for this. In the investigators' study, these two types of treatment are randomly assigned to patients with disease onset within the last year and not too far advanced disability or hemispheric brain injury. The patients are followed to assess prospectively the functional and brain MRI course of the disease.

NCT ID: NCT00503529 Completed - Clinical trials for Encephalitis, Tick-Borne

TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)

Start date: July 2007
Phase: Phase 4
Study type: Interventional

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 Study 223, by means of ELISA (IMMUNOZYM FSME IgG) and Neutralization test (NT), - TBE antibody response to a second booster vaccination with FSME-IMMUN 0.5ml in the present study, by means of ELISA and NT, - Safety of FSME-IMMUN 0.5ml after the second booster vaccination.

NCT ID: NCT00463684 Completed - Clinical trials for Japanese Encephalitis

Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age

JEV03
Start date: July 7, 2007
Phase: Phase 4
Study type: Interventional

To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater than 80% for JE and greater than 90% for measles.

NCT ID: NCT00463476 Completed - Clinical trials for Japanese Encephalitis

Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine

Start date: July 9, 2007
Phase: Phase 4
Study type: Interventional

To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine in children at 2 and 5 years of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination of SA 14-14-2 in subjects 2 and 5 years of age who have already received at least two doses of mouse brain-derived inactivated JE vaccine is greater than 80%. Japanese encephalitis virus is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people—including 700 million children—live in areas at risk in Asia for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.

NCT ID: NCT00460486 Completed - Clinical trials for Encephalitis, Tick-Borne

Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.

NCT ID: NCT00452621 Completed - Clinical trials for Encephalitis, Tick-Borne

Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

Start date: February 2007
Phase: Phase 4
Study type: Interventional

blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children

NCT ID: NCT00441259 Completed - Clinical trials for Japanese Encephalitis

Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

Start date: January 2007
Phase: Phase 2
Study type: Interventional

This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period. Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.

NCT ID: NCT00412516 Completed - Clinical trials for Encephalitis, Japanese B

Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The previously conducted JEV01 study looked at the immunogenicity and safety of the concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the one month post vaccination time point. The purpose of the JEV01 study was to help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants who received both vaccines and completed the JEV01 study. This study, however, will provide crucial data to help ensure the long-term immunogenicity of the concurrent administration of these vaccines and provide valuable information to determine the use of these vaccines in routine immunization programs. This study is planned because in the original protocol for JEV01, long-term data points were not included. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24 and 36 months post vaccination) protection against these diseases at the same level as those who receive the vaccines at different intervals.

NCT ID: NCT00387634 Completed - Clinical trials for Tick Born Encephalitis

Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

Start date: September 2006
Phase: Phase 4
Study type: Interventional

evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster

NCT ID: NCT00381433 Completed - Encephalitis Clinical Trials

Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid

Start date: September 2006
Phase: Phase 1
Study type: Interventional

AVI-4020 Injection, a phosphorodiamidate Morpholino oligomer (PMO), was found to cross the blood-brain barrier during a study of patients with presumptive West Nile virus disease. AVI-4065, which was designed to target HCV, is also a PMO; its ability to cross the blood-brain barrier is unknown. In this study, a single dose of AVI-4065 will be subcutaneously injected, and samples collected to determine if this drug crosses the blood-brain barrier. If it does, then additional investigations could be performed in people with severe forms of HCV disease in which the brain is affected.