Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04895449
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04895449
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : November 30, 2021
Sponsor:
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  ICMJE April 24, 2021
First Posted Date  ICMJE May 20, 2021
Last Update Posted Date November 30, 2021
Actual Study Start Date  ICMJE July 16, 2021
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE Biological: MVA-SARS-2-ST
i.m. vaccine administration
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2021)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2021)
240
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marylyn M Addo, MD +49 407410 ext 0 m.addo@uke.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04895449
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Marylyn M Addo, MD Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP