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.
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the MERS-CoV spike glycoprotein (S). A total of 24 participants will receive the following vaccine regime: 12 participants will receive 10\^7 plaque-forming units (PFU) of MVA-MERS-S on days 0 and 28. 12 participants will receive 10\^8 PFU of MVA-MERS-S on days 0 and 28. Safety and immunogenicity data will be collected throughout the study, which concludes at day 180. Update March 2019: A subgroup of participants from both dose cohorts will receive a late booster immunization of 10\^8 PFU MVA-MERS-S 12 months (+/- 4 months) after prime immunization.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
26
vaccination with MVA-MERS-S in two escalating dose regimes
CTC North GmbH & Co. KG at the University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
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.
Time frame: 14 days after each vaccination
Percentage of Participants Who Experienced an Unsolicited Adverse Event
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.
Time frame: 28 days after each vaccination
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)
The safety laboratory measures include: \- Clinical Chemistry: CRP in miligrams per liter \[mg/l\]
Time frame: Throughout the study up to conclusion
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)
The safety laboratory measures include Hematology: WBC count in billions per liter \[billion cells/L\]
Time frame: Throughout the study up to conclusion
Percentage of Participants Experiencing a Serious Adverse Event up to Day 180 (Study Completion)
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.
Time frame: Throughout the study up to conclusion
Immunogenicity: Number of Participants Who Seroconverted Throughout the Study (up to Study Completion at Day 180)
Humoral immunity: The magnitude of MVA-MERS-S antibody responses as assessed by neutralization assay and ELISA.
Time frame: Throughout the study up to conclusion
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