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

Study Overview
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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).

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.

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

Conditions
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Covid19

Intervention / Treatment
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* Biological: MVA-SARS-2-ST


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ≥ 1 x 10E7 IU (low dose) in seronegative subjects<br>≥ 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<br>* i.m. vaccine administration<br>|
| Experimental: ≥ 5 x 10E7 IU (middle dose) in seronegative subjects<br>≥ 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<br>* i.m. vaccine administration<br>|
| Experimental: ≥ 1 x 10E8 IU (high dose)in seronegative subjects<br>≥ 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<br>* i.m. vaccine administration<br>|
| Experimental: ≥ 1 x 10E7 IU (low dose)<br>≥ 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<br>* i.m. vaccine administration<br>|
| Experimental: ≥ 5 x 10E7 IU (middle dose)<br>≥ 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<br>* i.m. vaccine administration<br>|
| Experimental: ≥ 1 x 10E8 IU (high dose)<br>≥ 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<br>* i.m. vaccine administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the entire study (up to 6 months) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MVA, SARS-CoV-2, vaccine, booster vaccination