MERS (Middle East Respiratory Syndrome)Phase 1MVA-MERS-SNCT04119440
Safety and Immunogenicity of the Candidate Vaccine MVA-MERS-S_DF-1 Against MERS
A Phase 1 study testing MVA-MERS-S_DF1 - Low Dose and MVA-MERS-S_DF1 - High Dose in people with MERS (Middle East Respiratory Syndrome), run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- MERS (Middle East Respiratory Syndrome)
- What is being tested?
- MVA-MERS-S_DF1 - Low Dose and MVA-MERS-S_DF1 - High Dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Apr 2021to 6 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- MERS (Middle East Respiratory Syndrome)
- Being tested
- MVA-MERS-S_DF1 - Low Dose, MVA-MERS-S_DF1 - High Dose, Placebo
- Keywords
- MERS-CoV, CEPI, viral vector vaccine
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-MERS-S_DF1 - Low DoseBiological
Administrations of the low dose via the intramuscular route
MVA-MERS-S_DF1 - High DoseBiological
Administrations of the high dose via the intramuscular route
PlaceboOther
Administrations of placebo via the intramuscular route
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Vaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336. Receives: Biological: MVA-MERS-S_DF1 - Low Dose |
| High Dose | Experimental | Vaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336. Receives: Biological: MVA-MERS-S_DF1 - High Dose |
| Placebo | Placebo comparator | Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events associated with MVA-MERS-S_DF-1.
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.
Measured: day 1, 14, 29, 42, 56, 84, 168, 336, 364
Frequency and severity of local injection site reactogenicity signs and symptoms
Measured: day 1, 14, 29, 42, 84, 336
Secondary outcomes (1)
Immunogenicity
Magnitude of MERS-S-specific antibody re-sponses (ELISA and neutralization assays) monitored in a centralized approved laboratory
Measured: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start16 Apr 2021
- Primary completion28 Nov 2022
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MERS (Middle East Respiratory Syndrome)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded with an open-label run-in Phase (Part A) Part A: Open-label Part B: Double-blind
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Coalition for Epidemic Preparedness Innovations, IDT Biologika Dessau.Rossau, German Center for Infection Research, CR2O, Erasmus Medical Center, Monipol Deutschland GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119440
- Sponsor's protocol ID
- CEPI-MVA-MERS-S-Phase1b
- Acronym
- MVA-MERS-S
- Status last verified
- Apr 2025
- First submitted
- 6 Oct 2019
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raadsen MP, Dahlke C, Fathi A, Hardtke S, Kluver M, Krahling V, Gerresheim GK, Mayer L, Mykytyn AZ, Weskamm LM, Zoran T, van Gorp ECM, Sutter G, Becker S, Haagmans BL, Addo MM; MVA-MERS-S_DF-1 Study group. Safety, immunogenicity, and optimal dosing of a modified vaccinia Ankara-based vaccine against MERS-CoV in healthy adults: a phase 1b, double-blind, randomised placebo-controlled clinical trial. Lancet Infect Dis. 2025 Feb;25(2):231-242. doi: 10.1016/S1473-3099(24)00423-7. Epub 2024 Oct 7.
PubMed 39389076
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04119440
- Acronym / sponsor ID
- MVA-MERS-S / CEPI-MVA-MERS-S-Phase1b
- Conditions
- MERS (Middle East Respiratory Syndrome)
- Keywords
- MERS-CoV, CEPI, viral vector vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Coalition for Epidemic Preparedness Innovations, IDT Biologika Dessau.Rossau, German Center for Infection Research, CR2O, Erasmus Medical Center, Monipol Deutschland GmbH
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blinded with an open-label run-in Phase (Part A) Part A: Open-label Part B: Double-blind
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Biological: MVA-MERS-S_DF1 - Low DoseVaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336. |
| High Dose | Experimental | Biological: MVA-MERS-S_DF1 - High DoseVaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336. |
| Placebo | Placebo comparator | Other: PlaceboInjection with placebo. Injections will be administered at days 0, 28 or 56, and 336. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA-MERS-S_DF1 - Low DoseAdministrations of the low dose via the intramuscular route | Biological | Low Dose |
| MVA-MERS-S_DF1 - High DoseAdministrations of the high dose via the intramuscular route | Biological | High Dose |
| PlaceboAdministrations of placebo via the intramuscular route | Other | Placebo |
Primary outcome
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
1 secondary outcome
Immunogenicity
Time frame: day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 39389076Raadsen MP, Dahlke C, Fathi A, Hardtke S, Kluver M, Krahling V, Gerresheim GK, Mayer L, Mykytyn AZ, Weskamm LM, Zoran T, van Gorp ECM, Sutter G, Becker S, Haagmans BL, Addo MM; MVA-MERS-S_DF-1 Study group. Safety, immunogenicity, and optimal dosing of a modified vaccinia Ankara-based vaccine against MERS-CoV in healthy adults: a phase 1b, double-blind, randomised placebo-controlled clinical trial. Lancet Infect Dis. 2025 Feb;25(2):231-242. doi: 10.1016/S1473-3099(24)00423-7. Epub 2024 Oct 7.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA-MERS-S_DF1 - Low Dose and MVA-MERS-S_DF1 - High Dose in people with MERS (Middle East Respiratory Syndrome), run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events associated with MVA-MERS-S_DF-1. (time frame: day 1, 14, 29, 42, 56, 84, 168, 336, 364). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04119440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.