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
Latest Information Update: 14 Dec 2023
At a glance
- Drugs MVA MERS S (Primary)
- Indications Middle East respiratory syndrome coronavirus
- Focus Adverse reactions; First in man
- 04 Dec 2023 Planned End Date changed from 1 May 2023 to 30 May 2024.
- 06 Nov 2022 Planned primary completion date changed from 1 Oct 2022 to 1 Nov 2022.
- 06 Nov 2022 Status changed from recruiting to active, no longer recruiting.
Most Recent Events
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 |
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Middle East respiratory syndrome coronavirus | prevention | - |
Subjects
- Subject Type patients
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Number
Planned: 160
Actual: 145
- 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 |
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NCT04119440 | ClinicalTrials.gov: US National Institutes of Health |
CEPI-MVA-MERS-S-Phase1b | - |
Trial Dates
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Initiation Dates
Planned : 01 Dec 2020
Actual : 16 Apr 2021
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Primary Completion Dates
Planned : 01 Nov 2022
Actual : 28 Nov 2022
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End Dates
Planned : 30 May 2024
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 |
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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 |
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Alen Jambrecina, MD
a.jambrecina@ctc-north.com
show details
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CTC North | Germany |
Eric van Gorp, Prof
+31 10 7030310
show details
e.vangorp@erasmusmc.nl |
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Marylyn M Addo, Prof
+49 40 7410 51102
show details
m.addo@uke.de |
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Matthijs Raadsen, MD
m.p.raadsen@erasmusmc.nl
show details
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Erasmus Medical Centre | Netherlands |
Centres
Centre Name | Location | Trial Centre Country |
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- |
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Clinical Trial Center North (CTC North GmbH & Co. KG) |
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Coalition for Epidemic Preparedness Innovations |
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CR2O |
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CTC North | Hamburg | Germany |
Erasmus Medical Center |
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Erasmus Medical Centre | Rotterdam | Netherlands |
German Center for Infection Research |
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IDT Biologika Dessau.Rossau |
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Universitätsklinikum Hamburg-Eppendorf |
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Trial History
Event Date | Event Type | Comment |
---|---|---|
14 Dec 2023 | Other trial event | Last checked against Clinicaltrials.gov record. Updated 14 Dec 2023 |
04 Dec 2023 | Completion date | Planned End Date changed from 1 May 2023 to 30 May 2024. Updated 14 Dec 2023 |
06 Nov 2022 | Other trial event | Planned primary completion date changed from 1 Oct 2022 to 1 Nov 2022. Updated 09 Nov 2022 |
06 Nov 2022 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 09 Nov 2022 |
26 Aug 2022 | Completion date | Planned End Date changed from 1 May 2022 to 1 May 2023. Updated 30 Aug 2022 |
26 Aug 2022 | Other trial event | Planned primary completion date changed from 1 May 2022 to 1 Oct 2022. Updated 30 Aug 2022 |
24 Apr 2021 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 30 Apr 2021 |
28 Sep 2020 | Completion date | Planned End Date changed from 1 Dec 2021 to 1 May 2022. Updated 01 Oct 2020 |
28 Sep 2020 | Other trial event | Planned primary completion date changed from 1 Dec 2021 to 1 May 2022. Updated 01 Oct 2020 |
28 Sep 2020 | Other trial event | Planned initiation date changed from 1 May 2020 to 1 Dec 2020. Updated 01 Oct 2020 |
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 |
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
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
The development of a vaccine against MERS virus gets international support. Media-Rel 2018;.
Media Release -
German Center for Infection Research. MERS coronavirus: vaccine in development. Media-Rel 2015;.
Media Release -
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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