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

• ClinicalTrials.gov Identifier: NCT04895449
• Recruitment Status: Completed
• First Posted: May 20, 2021
• Last Update Posted: January 18, 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)
• Information provided by (Responsible Party): Universitätsklinikum Hamburg-Eppendorf

Tracking Information

• First Submitted Date: April 24, 2021
• First Posted Date: May 20, 2021
• Last Update Posted Date: January 18, 2023
• Actual Study Start Date: July 16, 2021
• Actual Primary Completion Date: November 2, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2021)

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) ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 29, 2021)

Number of participants who seroconverted [ Time Frame: during the entire study (up to 6 months) ]

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

Original Secondary Outcome Measures (submitted: May 15, 2021)

Immunogenicity [ Time Frame: during the entire study (up to 6 months) ]

Number of participants who seroconverted. Magnitude of SARS-CoV-2 specific antibody responses (ELISA and neutralization assay)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19
• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Covid19

Intervention

Biological: MVA-SARS-2-ST

i.m. vaccine administration

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
  Intervention: 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
  Intervention: 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
  Intervention: 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
  Intervention: 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
  Intervention: 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
  Intervention: Biological: MVA-SARS-2-ST

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2023): 43
• Original Estimated Enrollment (submitted: May 15, 2021): 240
• Actual Study Completion Date: November 8, 2022
• Actual Primary Completion Date: November 2, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04895449
• Other Study ID Numbers: UKE-SARS-CoV-2-ST
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• Original Responsible Party: Same as current
• Current Study Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Original Study Sponsor: Same as current

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)

Investigators

• Principal Investigator: Marylyn M Addo, MD; Universitätsklinikum Hamburg-Eppendorf

• PRS Account: Universitätsklinikum Hamburg-Eppendorf
• Verification Date: January 2023