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Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19 (MVA-SARS2-ST)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
MVA-SARS-2-ST
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring MVA, SARS-CoV-2, vaccine, booster vaccination

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Uniklinik Köln
  • CTC North

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

≥ 1 x 10E7 IU (low dose) in seronegative subjects

≥ 5 x 10E7 IU (middle dose) in seronegative subjects

≥ 1 x 10E8 IU (high dose)in seronegative subjects

≥ 1 x 10E7 IU (low dose)

≥ 5 x 10E7 IU (middle dose)

≥ 1 x 10E8 IU (high dose)

Arm Description

≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects

≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects

≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects

≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects

≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects

≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2021
Last Updated
January 15, 2023
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Center for Infection Research, Philipps University Marburg Medical Center, Ludwig-Maximilians - University of Munich, IDT Biologika, Clinical Trial Center North (CTC North GmbH & Co. KG)
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1. Study Identification

Unique Protocol Identification Number
NCT04895449
Brief Title
Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19
Acronym
MVA-SARS2-ST
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Center for Infection Research, Philipps University Marburg Medical Center, Ludwig-Maximilians - University of Munich, IDT Biologika, Clinical Trial Center North (CTC North GmbH & Co. KG)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
MVA, SARS-CoV-2, vaccine, booster vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
≥ 1 x 10E7 IU (low dose) in seronegative subjects
Arm Type
Experimental
Arm Description
≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects
Arm Title
≥ 5 x 10E7 IU (middle dose) in seronegative subjects
Arm Type
Experimental
Arm Description
≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects
Arm Title
≥ 1 x 10E8 IU (high dose)in seronegative subjects
Arm Type
Experimental
Arm Description
≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects
Arm Title
≥ 1 x 10E7 IU (low dose)
Arm Type
Experimental
Arm Description
≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects
Arm Title
≥ 5 x 10E7 IU (middle dose)
Arm Type
Experimental
Arm Description
≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects
Arm Title
≥ 1 x 10E8 IU (high dose)
Arm Type
Experimental
Arm Description
≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects
Intervention Type
Biological
Intervention Name(s)
MVA-SARS-2-ST
Intervention Description
i.m. vaccine administration
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
Description
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 Outcome Measure Information:
Title
Number of participants who seroconverted
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marylyn M Addo, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniklinik Köln
City
Cologne
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany
Facility Name
CTC North
City
Hamburg
ZIP/Postal Code
20251
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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