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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-16

Study Completion Date

2022-11-08

Brief Summary

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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).

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Detailed Description

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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

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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≥ 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

Group Type EXPERIMENTAL

MVA-SARS-2-ST

Intervention Type BIOLOGICAL

i.m. vaccine administration

≥ 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

Group Type EXPERIMENTAL

MVA-SARS-2-ST

Intervention Type BIOLOGICAL

i.m. vaccine administration

≥ 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

Group Type EXPERIMENTAL

MVA-SARS-2-ST

Intervention Type BIOLOGICAL

i.m. vaccine administration

≥ 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

Group Type EXPERIMENTAL

MVA-SARS-2-ST

Intervention Type BIOLOGICAL

i.m. vaccine administration

≥ 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

Group Type EXPERIMENTAL

MVA-SARS-2-ST

Intervention Type BIOLOGICAL

i.m. vaccine administration

≥ 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

Group Type EXPERIMENTAL

MVA-SARS-2-ST

Intervention Type BIOLOGICAL

i.m. vaccine administration

Interventions

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MVA-SARS-2-ST

i.m. vaccine administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
2. Previous rMVA immunization.
3. Previous immunization with investigational vaccine against COVID-19.
4. Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
5. Evidence of active SARS-CoV-2 infection
6. 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.
7. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
8. 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.
9. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
10. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
11. Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes