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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

Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Apr 2020

At a glance

  • Drugs MVA MERS S (Primary)
  • Indications Middle East respiratory syndrome coronavirus
  • Focus Adverse reactions; First in man
  • Most Recent Events

    • 21 Apr 2020 According to a German Center for Infection Research media release, this study is funded by CEPI (Coalition for Epidemic preparedness Innovation).
    • 07 Sep 2018 New trial record

Trial Overview

Purpose

This phase 1b trial will evaluate MVA-MERS-S, an experimental prophylactic vaccine against the Middle East Respiratory Virus Syndrome.

Primary Endpoints

Frequency of adverse events associated with MVA-MERS-S_DF-1.

description: 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.
time_frame: day 1, 14, 29, 42, 56, 84, 168, 336, 364

Frequency and severity of local injection site reactogenicity signs and symptoms

time_frame: day 1, 14, 29, 42, 84, 336

Other Endpoints

Immunogenicity

description: Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory
time_frame: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme) [1]

Diseases Treated

Indication Qualifiers Patient Segments
Middle East respiratory syndrome coronavirus prevention -

Subjects

  • Subject Type volunteers
  • Number

    Planned: 160

  • Sex male & female
  • Age Group 18-55 years; adult

Patient 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04119440 ClinicalTrials.gov: US National Institutes of Health
CEPI-MVA-MERS-S-Phase1b -

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

  • Primary Completion Dates

    Planned : 01 Dec 2021

  • End Dates

    Planned : 01 Dec 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase I
  • Location Germany; Netherlands
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
MVA MERS SPrimary Drug Intramuscular Injection

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)

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

Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.
Other: Placebo (Administrations of placebo via the intramuscular route)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Alen Jambrecina, MD
a.jambrecina@ctc-north.com
show details
CTC North Germany
Eric van Gorp, Prof
+31 10 7030310
e.vangorp@erasmusmc.nl
show details
-
Marylyn M Addo, Prof
+49 40 7410 51102
m.addo@uke.de
show details
-
Matthijs Raadsen, MD
m.p.raadsen@erasmusmc.nl
show details
Erasmus Medical Centre Netherlands

Centres

Centre Name Location Trial Centre Country
-
-
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Clinical Trial Center North (CTC North GmbH & Co. KG)
-
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Coalition for Epidemic Preparedness Innovations
-
-
CR2O
-
-
CTC North Hamburg Germany
Erasmus Medical Center
-
-
Erasmus Medical Centre Rotterdam Netherlands
German Center for Infection Research
-
-
IDT Biologika Dessau.Rossau
-
-
Universitätsklinikum Hamburg-Eppendorf
-
-

Trial History

Event Date Event Type Comment
21 Apr 2020 Other trial event According to a German Center for Infection Research media release, this study is funded by CEPI (Coalition for Epidemic preparedness Innovation). Updated 28 Apr 2020
20 Jan 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 20 Jan 2020
10 Oct 2019 Other trial event New source identified and integrated: ClinicalTrials.gov: US National Institutes of Health (NCT04119440). Updated 10 Oct 2019
07 Sep 2018 New trial record New trial record Updated 07 Sep 2018
17 Jun 2015 Other trial event According to a German Center for Infection Research media release, phase I clinical investigation of MVA-MERS-S will be conducted at the DZIF under the supervision of Gerd Sutter. Updated 07 Sep 2018

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. The development of a vaccine against MERS virus gets international support. Media-Rel 2018;.

    Media Release
  3. German Center for Infection Research. MERS coronavirus: vaccine in development. Media-Rel 2015;.

    Media Release
  4. German Center for Infection Research. Promising MERS coronavirus vaccine trial on humans - useful insights for vaccine development against SARS-CoV-2. Media-Rel 2020;.

    Media Release
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