Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS (MVA-MERS-S)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04119440|
Recruitment Status : Active, not recruiting
First Posted : October 8, 2019
Last Update Posted : November 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|MERS (Middle East Respiratory Syndrome)||Biological: MVA-MERS-S_DF1 - Low Dose Biological: MVA-MERS-S_DF1 - High Dose Other: Placebo||Phase 1|
This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 years
The study is separated in two parts:
The study starts with a single center open-label run-in phase of two dose levels (cohort 1 "low dose": 2x10^7 PFU, cohort 2 "high dose": 2x10^8 PFU) in 10 healthy subjects. 5 subjects will be allocated to each dose cohort and will receive immunization on day 0 and day 28.
Two-center, randomized, double-blind, placebo-controlled, dose-finding study. This part is a double-blinded trial in approximately 150 healthy subjects. Subjects will be allocated to two different dose cohorts and a placebo cohort; each receiving three vaccine injections.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blinded with an open-label run-in Phase (Part A) Part A: Open-label Part B: Double-blind|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects|
|Actual Study Start Date :||April 16, 2021|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||May 2023|
Experimental: Low Dose
Vaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
Biological: MVA-MERS-S_DF1 - Low Dose
Administrations of the low dose via the intramuscular route
Experimental: High Dose
Vaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
Biological: MVA-MERS-S_DF1 - High Dose
Administrations of the high dose via the intramuscular route
Placebo Comparator: Placebo
Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.
Administrations of placebo via the intramuscular route
- Frequency of adverse events associated with MVA-MERS-S_DF-1. [ Time Frame: day 1, 14, 29, 42, 56, 84, 168, 336, 364 ]Safety and reactogenicity will be assesssed by observation, questionaire and diary. Changes from baseline for safety laboratory measures will be monitored. Occurence of SAE will be collected throughout the entire study duration.
- Frequency and severity of local injection site reactogenicity signs and symptoms [ Time Frame: day 1, 14, 29, 42, 84, 336 ]
- Immunogenicity [ Time Frame: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme) ]Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Written informed consent form.
- Healthy male and female subjects aged 18-55 years.
- No clinically significant acute health problems as determined from medical history and physical examination at screening visit.
- Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening.
- Non-pregnant, non-lactating female with negative pregnancy test.
- Males and females who agree to comply with the applicable contraceptive requirements of the protocol.
- Receipt of any vaccine from 2 weeks prior to each trial vac-cination (4 weeks for live vaccines) to 3 weeks after each trial vaccination.
- Receipt of vaccination against MERS or MVA immunizations.in the medical history.
- Known allergy to the components of the MVA-MERS-S_DF-1 vaccine product.
- Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product.
- Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119440
|Hamburg, Germany, 20251|
|Erasmus Medical Centre|
|Rotterdam, Netherlands, 3015|
|Responsible Party:||Universitätsklinikum Hamburg-Eppendorf|
|Other Study ID Numbers:||
|First Posted:||October 8, 2019 Key Record Dates|
|Last Update Posted:||November 8, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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