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Japanese Encephalitis clinical trials

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NCT ID: NCT01856205 Completed - Clinical trials for Japanese Encephalitis

Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

Start date: May 2009
Phase: Phase 2
Study type: Interventional

Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening conscious level and seizures. Around a third will die from the infection and half of survivors have serious long-term neurological disability. The majority of those affected are children. There are many causes of viral encephalitis, however Japanese encephalitis virus is the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia and the geographical range is expanding. There is no specific treatment for Japanese encephalitis virus, although several have been trialed. In this study we examined the effect of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese encephalitis virus and suppress damaging inflammation in the brain. It has previously been used in individual cases but never examined in a randomized trial. There was recently a trial of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is safe in this context, and that this treatment may alter the way the immune system manages the infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely given to children with suspected JE, with no increased risk of serious adverse events compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory markers called cytokines and blood brain barrier markers, and the effect of IVIG on these relationships.

NCT ID: NCT01815073 Completed - Clinical trials for Japanese Encephalitis

Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine

Start date: March 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine,live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.

NCT ID: NCT01662440 Completed - Rabies Clinical Trials

Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

Start date: August 2012
Phase: Phase 3
Study type: Interventional

Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.

NCT ID: NCT01656200 Completed - Clinical trials for Japanese Encephalitis

A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2

Start date: May 2012
Phase: Phase 4
Study type: Interventional

Japanese encephalitis (JE) live attenuated vaccine SA14-14-2 has been in use for more more than 20 years in Asia. JE vaccine SA14-14-2 is licensed in India and has been widely used since 2006. JE vaccines give protection by generating a neutralizing antibody response, but both naturally exposed persons and patients with JE also have T cell responses. Whether JE vaccine SA14-14-2 elicits T cell responses is unknown. This study tests the hypothesis that T cell responses are generated in response to JE SA14-14-2 vaccination. The aim of this study is to characterize T cell responses to JE vaccine SA14-14-2 in healthy people, and to investigate differences in T cell responses between natural exposure, vaccination and disease.

NCT ID: NCT01567865 Completed - Clinical trials for Japanese Encephalitis

Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine

Start date: May 2012
Phase: Phase 4
Study type: Interventional

The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.

NCT ID: NCT01466387 Completed - Clinical trials for Meningococcal Disease

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults

Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.

NCT ID: NCT01396512 Completed - Clinical trials for Japanese Encephalitis

Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine [CD.JEVAX™]) after a single dose vaccination to support product registration. Primary Objective: - To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine. Secondary Objectives: - To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine. - To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.

NCT ID: NCT01386827 Completed - Clinical trials for Japanese Encephalitis

Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis

Start date: January 2008
Phase: Phase 3
Study type: Interventional

The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro. Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune responses in four groups: A) primary immunization with BMJEV, B) primary and secondary immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of serum samples collected before and after vaccination.

NCT ID: NCT01335412 Completed - Clinical trials for Japanese Encephalitis

Safety Surveillance After Immunization With IXIARO

Start date: March 2011
Phase: N/A
Study type: Observational

This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military, to detect adverse events that occur more frequently after IXIARO and to electronically follow up pregnancies during or shortly before which IXIARO was administered. There will be no intervention and no individuals contacted.

NCT ID: NCT01296360 Completed - Clinical trials for Japanese Encephalitis

Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country

Start date: December 2010
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.