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Trial record 1 of 1 for:    NCT04895449
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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04895449
Recruitment Status : Active, not recruiting
First Posted : May 20, 2021
Last Update Posted : November 8, 2022
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

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).

Condition or disease Intervention/treatment Phase
Covid19 Biological: MVA-SARS-2-ST Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : July 16, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Biological: MVA-SARS-2-ST
i.m. vaccine administration

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
Biological: MVA-SARS-2-ST
i.m. vaccine administration

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
Biological: MVA-SARS-2-ST
i.m. vaccine administration

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
Biological: MVA-SARS-2-ST
i.m. vaccine administration

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
Biological: MVA-SARS-2-ST
i.m. vaccine administration

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
Biological: MVA-SARS-2-ST
i.m. vaccine administration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04895449


Locations
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Germany
Uniklinik Köln
Cologne, NRW, Germany, 50937
CTC North
Hamburg, Germany, 20251
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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
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Principal Investigator: Marylyn M Addo, MD Universitätsklinikum Hamburg-Eppendorf
  Study Documents (Full-Text)

Documents provided by Universitätsklinikum Hamburg-Eppendorf:
Study Protocol  [PDF] October 5, 2021

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04895449    
Other Study ID Numbers: UKE-SARS-CoV-2-ST
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
MVA
SARS-CoV-2
vaccine
booster vaccination
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases