CompletedNCT04895449MVA-SARS2-STUpdated Jan 18, 2023

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

A Phase 1 interventional study of MVA-SARS-2-ST in Covid19, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 2 sites in Germany. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 43
Allocation: Non-randomized
Ages: 18 Years to 64 Years
Sex: All

Study 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 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 studied

Covid19

Browse trials for

COVID-19 7,640

Keywords

MVA
SARS-CoV-2
vaccine
booster vaccination

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 43 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 43 participants (actual)

Study arms

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

Interventions

BiologicalMVA-SARS-2-ST
i.m. vaccine administration

What researchers measure

Primary outcomes

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.
Time frame: during the entire study (up to 6 months)

Secondary outcomes

Number of participants who seroconverted
Magnitude of SARS-CoV-2-S specific antibody responses will be measured by ELISA and neutralization assays
Time frame: during the entire study (up to 6 months)

Study locations

2 sites

Uniklinik Köln
Cologne, NRW 50937, Germany
CTC North
Hamburg, 20251, Germany

References and documents

Study documents

Study protocol · Oct 5, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04895449
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Collaborators: German Center for Infection Research, Philipps University Marburg, Ludwig-Maximilians - University of Munich, IDT Biologika, Clinical Trial Center North (CTC North GmbH & Co. KG)
Responsible party: Sponsor
First posted: May 20, 2021
Start date: Jul 16, 2021
Primary completion: Nov 2, 2022
Completion: Nov 8, 2022
Last update: Jan 18, 2023

Study contacts

Marylyn M Addo, MD

principal investigator · Universitätsklinikum Hamburg-Eppendorf

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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