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drug1316 | LY3819253 Wiki | 0.71 |
drug1822 | Placebo Wiki | 0.06 |
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There is one clinical trial.
The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization (WHO) and currently without registered prevention or treatment option. In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will additionally receive a late booster vaccination. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.
Description: The solicited local adverse events for this study include: Swelling, erythema, induration, hematoma and pain at site of injection The solicited systemic adverse events for this study include: Fever Chills Myalgia (described to the subject as generalized muscle aches) Arthralgia (described to the subject as generalized joint aches) Fatigue/Malaise Headache Gastrointestinal symptoms The reactogenicity (adverse events) will be assessed via a trained physician taking into account a patient diary. The severity of the adverse event will be measured as specified in the study protocol (grade 0=none, grade 1=mild, grade 2=moderate, grade 3=severe). The adverse event will furthermore be categorized in related vs. not related.
Measure: Occurrence of solicited local and systemic reactogenicity as defined by the study protocol Time: 14 days after each vaccinationDescription: The unsolicited adverse events will be assessed via a trained physician taking into account a patient diary. The severity of the adverse event will be measured as specified in the study protocol (grade 0=none, grade 1=mild, grade 2=moderate, grade 3=severe). The adverse event will furthermore be categorized in related vs. not related.
Measure: Occurrence of unsolicited adverse events Time: 28 days after each vaccinationDescription: The safety laboratory measures include: Troponin T Clinical Chemistry Hematology Urine
Measure: Change from baseline of safety laboratory measures as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4 Time: Throughout the study up to conclusionDescription: Serious adverse events are defined as any untoward medical occurrence (whether considered to be related to investigational medicinal product or not) that at any dose: results in death is life-threatening requires inpatient hospitalization or prolongation of existing hospitalization results in persistent or significant disability/incapacity is a congenital abnormality/birth defect is an Important Medical Event, i.e., an event that may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measure: Occurrence of serious adverse events Time: Throughout the study up to conclusionDescription: Humoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA
Measure: Measures of immunogenicity to the MVA-MERS-S vaccine Time: Throughout the study up to conclusion