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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: Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol Time: 14 days after each vaccination
Description: 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: Percentage of Participants Who Experienced an Unsolicited Adverse Event Time: 28 days after each vaccination
Description: The safety laboratory measures include: - Clinical Chemistry: CRP in miligrams per liter [mg/l]Measure: Change of Mean C-reactive Protein (CRP) Levels (Measured in [mg/l]) From Baseline (Day -1 ) as Compared to the End of the Study (D180) Time: Throughout the study up to conclusion
Description: The safety laboratory measures include Hematology: WBC count in billions per liter [billion cells/L]Measure: Change of Mean White Blood Cell (WBC) Counts (Measured in [Billion Cells/L]) From Baseline (Day -1) as Compared to the End of the Study (D180) Time: Throughout the study up to conclusion
Description: 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: Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion) Time: Throughout the study up to conclusion
Description: Humoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA.Measure: Immunogenicity: Number of Participants Who Seroconverted Throughout the Study (up to Study Completion at Day 180) Time: Throughout the study up to conclusion
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports