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Trial record 5 of 12 for:    MERS (Middle East Respiratory Syndrome)

Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety and Immunogenicity of MVA-MERS-S_DF-1

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119440
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
Coalition for Epidemic Preparedness Innovations
IDT Biologika Dessau.Rossau
German Center for Infection Research
CR2O
Clinical Trial Center North (CTC North GmbH & Co. KG)
Erasmus Medical Center
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.

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

Detailed Description:

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:

Part A:

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.

Part B:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
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)
Masking Description: Double-blinded
Primary Purpose: Prevention
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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Placebo
Administrations of placebo via the intramuscular route




Primary Outcome Measures :
  1. 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.

  2. Frequency and severity of local injection site reactogenicity signs and symptoms [ Time Frame: day 1, 14, 29, 42, 84, 336 ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written informed consent form.
  2. Healthy male and female subjects aged 18-55 years.
  3. No clinically significant acute health problems as determined from medical history and physical examination at screening visit.
  4. Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening.
  5. Non-pregnant, non-lactating female with negative pregnancy test.
  6. Males and females who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion Criteria:

  1. 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.
  2. Receipt of vaccination against MERS or MVA immunizations.in the medical history.
  3. Known allergy to the components of the MVA-MERS-S_DF-1 vaccine product.
  4. 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.
  5. Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
  6. Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Information from the National Library of Medicine

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


Contacts
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Contact: Marylyn M Addo, Prof +49 40 7410 51102 m.addo@uke.de
Contact: Eric van Gorp, Prof +31 10 7030310 e.vangorp@erasmusmc.nl

Locations
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Germany
CTC North
Hamburg, Germany, 20251
Contact: Marylyn M Addo, Prof       m.addo@uke.de   
Contact: Alen Jambrecina, MD       a.jambrecina@ctc-north.com   
Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands, 3015
Contact: Eric van Gorp, Prof       e.vangorp@erasmusmc.ml   
Contact: Matthijs Raadsen, MD       m.p.raadsen@erasmusmc.nl   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Coalition for Epidemic Preparedness Innovations
IDT Biologika Dessau.Rossau
German Center for Infection Research
CR2O
Clinical Trial Center North (CTC North GmbH & Co. KG)
Erasmus Medical Center

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04119440    
Other Study ID Numbers: CEPI-MVA-MERS-S-Phase1b
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
MERS-CoV
CEPI
viral vector vaccine
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases