Track topics on Twitter Track topics that are important to you
The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels.
This is a double blinded, block-randomized, active- and placebo controlled, phase II trial, comparing two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK (a novel vaccine against Chikungunya virus).
Healthy male and female subjects aged 18-55 years will be randomized to one of six treatment groups (A, B, C. D, M1 or M2) differing in dosage and scheduling of vaccinations. Group A-D will be split in one arm receiving MV-CHIK and one control-arm receiving Priorix®.
All subjects of group A. B, C and D will receive three i.m. injections on study day 0, 28 and 196. Subjects of group A and B will receive MV-CHIK low dose or control-vaccine Priorix® (or equivalent measles vaccine) and subjects of group C and D will be treated with MV-CHIK high dose or control-vaccine (Priorix® or equivalent measles vaccine).
All subjects of group A, B, C and D additionally will be randomized to one of two treatment sequences: group A and C will receive MV-CHIK or control-vaccine Priorix® on study day 0 and 28, followed by placebo on day 196, and group B and D receive placebo on day 0 and MV-CHIK or Priorix® on day 28, followed by an additional vaccination of the same product on day196 (boosting vaccination).
All subjects of the measles booster group M1 and M2 will receive five i.m. injections on study day -28, 0, 28, 168 and 196. The first vaccination will be Priorix® (or equivalent measles vaccine) on study day -28. Group M1 will receive MV-CHIK low dose vaccinations on day 0 and day 28 and placebo on day 168 and 196. Group M2 will receive placebo on day 0 and 28 and MV-CHIK low dose on day 168 and on day 196.
All subjects will be followed for safety and immunogenicity evaluation until day 224. Study duration per subject is estimated to be 33-37 weeks (~8 months), respectively.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Chikungunya Virus Infection
MV-CHIK low dose, MV-CHIK high dose, Priorix®, physiological saline solution
Hansa Sanatorium GmbH
Not yet recruiting
Themis Bioscience GmbH
Published on BioPortfolio: 2016-08-11T08:23:21-0400
The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will be ...
This study is a randomized, double-blinded, Phase 1, placebo- controlled, and dose comparison trial to evaluate the safety, immunogenicity and schedule of MV-CHIK. Two dosage levels and 3 ...
Chikungunya is a viral disease transmitted by mosquitoes whose clinical feature is the early joint damage. Approximately 8% of patients have chronic arthropathy resembling to the rheumatoi...
The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and...
To evaluate the safety and immunogenicity of GSK Biologicals’ live attenuated MMR vaccine (Priorix) in a local population in Singapore. The vaccine was administered as a single dose to h...
Due to the huge 2-way human traffic between Japan and Chikungunya (CHIK) fever-endemic regions, 89 imported cases of CHIK fever were confirmed in Japan from January 2006 to June 2016. Fifty-four of 89...
Chikungunya (CHIK) is a mosquito-borne virus (CHIKV) infection that recently appeared in the Americas and thousands of confirmed cases have been reported in Brazil since the first autochthonous cases ...
To review the emergence, clinical features, pathogenesis, and treatment of acute chikungunya (CHIK) fever and chronic CHIK arthritis.
Chikungunya fever (CHIK) is an acute viral infection caused by infection with chikungunya virus (CHIKV). The disease affects people in areas where certain Aedes species mosquito vectors are present, e...
Chikungunya (CHIK) is a tropical arbovirus, transmitted by the female mosquito Aedes aegypti and Aedes albopictus. In Brazil, there have been cases reported since 2014. The initial manifestations of t...
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
A treatment schedule in which the total dose of radiation is divided into large doses.
Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
The specific failure of a normally responsive individual to make an immune response to a known antigen. It results from previous contact with the antigen by an immunologically immature individual (fetus or neonate) or by an adult exposed to extreme high-dose or low-dose antigen, or by exposure to radiation, antimetabolites, antilymphocytic serum, etc.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...