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Covid19Phase 1MVA-SARS2-STNCT04895449

Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19

A Phase 1 study testing MVA-SARS-2-ST in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B). Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
MVA-SARS-2-ST
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
2 sitesGermany
Study dates
16 Jul 2021to 8 Nov 2022
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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written informed consent.
  • Healthy male and female adults aged 18 - 64 at time of informed consent.
  • Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
  • Female participants: non-pregnant, non-lactating with negative pregnancy test.
  • Females who agree to comply with the applicable contraceptive requirements of the protocol.
  • ≥ 6 months fully vaccinated with a (conditionally)licensed mRNA vaccine against COVID-19 (Part B only)

Who cannot join

  • Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
  • Previous rMVA immunization.
  • Previous immunization with investigational vaccine against COVID-19.
  • Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
  • Evidence of active SARS-CoV-2 infection
  • Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
Show all 11Show fewer
  • Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
  • Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product.
  • Clinically relevant findings in ECG or significant thromboembolic events in medical history.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
  • Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Uniklinik Köln

    Cologne, North Rhine-Westphalia, 50937

  • CTC North

    Hamburg, 20251

Other trials in Germany

About this study

Official title: A Multi-center Phase Ib Trial to Assess the Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST in Adults

Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).

Read the detailed description

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized SARS-CoV-2 spike protein (S).

This will be a phase Ib multi-center study in approximately 60 adults aged 18-64 years.

Part A (N=24 seronegative subjects). Each participant will receive two single injections, 28 days apart.

  • low dose ≥ 1 x 10e7 IU (N=8)
  • middle dose ≥ 5 x 10e7 IU (N=8)
  • high dose ≥ 1 x 10e8 IU (N=8)

Part B (N=36 previously mRNA vaccinated subjects). Each participant will receive a single injection.

  • low dose ≥ 1 x 10e7 IU (N=12)
  • middle dose ≥ 5 x 10e7 IU (N=12)
  • high dose ≥ 1 x 10e8 IU (N=12)

All participants will be followed up for safety until D168.

Conditions
Covid19
Being tested
MVA-SARS-2-ST
Keywords
MVA, SARS-CoV-2, vaccine, booster vaccination
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVA-SARS-2-STBiological

    i.m. vaccine administration

Study groups in NCT04895449
Study groupRoleWhat they receive
≥ 1 x 10E7 IU (low dose) in seronegative subjectsExperimental≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 \& 28) in seronegative subjects
Receives: Biological: MVA-SARS-2-ST
≥ 5 x 10E7 IU (middle dose) in seronegative subjectsExperimental≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 \& 28) in seronegative subjects
Receives: Biological: MVA-SARS-2-ST
≥ 1 x 10E8 IU (high dose)in seronegative subjectsExperimental≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 \& 28) in seronegative subjects
Receives: Biological: MVA-SARS-2-ST
≥ 1 x 10E7 IU (low dose)Experimental≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects
Receives: Biological: MVA-SARS-2-ST
≥ 5 x 10E7 IU (middle dose)Experimental≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects
Receives: Biological: MVA-SARS-2-ST
≥ 1 x 10E8 IU (high dose)Experimental≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects
Receives: Biological: MVA-SARS-2-ST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol

    Safety and reactogenicity will be assessed by observation, questionaire and diary. Occurence of Serious Adverse Events (SAE) will be collected throughout the entire study duration.

    Measured: during the entire study (up to 6 months)

Secondary outcomes (1)

  1. Number of participants who seroconverted

    Magnitude of SARS-CoV-2-S specific antibody responses will be measured by ELISA and neutralization assays

    Measured: during the entire study (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start16 Jul 2021
  3. Primary completion2 Nov 2022
  4. Study completion8 Nov 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895449
Sponsor's protocol ID
UKE-SARS-CoV-2-ST
Acronym
MVA-SARS2-ST
Status last verified
Jan 2023
First submitted
24 Apr 2021
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grewe I, Friedrich M, Dieck ML, Spohn M, Ly ML, Krahling V, Mayer L, Mellinghoff SC, Rottstegge M, Kraemer R, Volz A, Becker S, Fathi A, Dahlke C, Weskamm LM, Addo MM. MVA-based SARS-CoV-2 vaccine candidates encoding different spike protein conformations induce distinct early transcriptional responses which may impact subsequent adaptive immunity. Front Immunol. 2024 Dec 19;15:1500615. doi: 10.3389/fimmu.2024.1500615. eCollection 2024.

    PubMed 39749328

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA-SARS-2-ST in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.

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 11 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 18 Jan 2023. 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. 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. 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?

Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol (time frame: during the entire study (up to 6 months)). 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 NCT04895449, 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 18 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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