Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : September 2, 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

Brief Summary:
Multi-center, randomized-controlled phase Ib/IIa study with an open-label run-in phase and an open-label exploratory study arm to evaluate previously SARS-CoV-2-infected/vaccinated individuals.

Condition or disease Intervention/treatment Phase
Covid19 Biological: MVA-SARS-2-ST Biological: Licensed COVID-19 vaccine Phase 1 Phase 2

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/IIa, multi-center study in approximately 240 adults aged 18 years and older.

Study starts with an open-label run-in phase of three dose levels (Part A):

  • low dose ≥ 1 x 107 IU (N=10)
  • middle dose ≥ 5 x 107 IU (N=10)
  • high dose ≥ 1 x 108 IU (N=10)

Part B: Multi-center, open-label study. Participants with previous SARS-CoV-2 infection or vaccination against SARS-CoV-2 will be recruited at 2 to 5 study sites in Germany and will receive one dose of MVA-SARS-2-ST. Participants will be recruited at 2 to 5 study sites in Germany. Participants will be randomized to one of the following cohorts (ratio 2:2:1)

  • low or middle dose on day 0, 28 (N = 60)
  • middle or high dose on day 0, 28 (N = 60)
  • Licensed COVID-19 Vaccine on day 0, day 28 (N = 30) Each participant will receive two single injections, 28 days apart. All participants will be followed up for safety until D168.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blinded (Phase IIa, Part A) with an open-label run-in Phase (Phase Ib) and an open-label Part (Phase IIa, Part B)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blinded
Primary Purpose: Prevention
Official Title: A Multi-center, Randomized Controlled, Phase Ib/IIa 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 : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Arm Intervention/treatment
Experimental: ≥ 1 x 10E7 IU (low dose)
≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28)
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: MVA-SARS-2-ST vaccinations (days 0 & 28)
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: MVA-SARS-2-ST vaccinations (days 0 & 28)
Biological: MVA-SARS-2-ST
i.m. vaccine administration

Active Comparator: Active Comparator
COVID-19 Vaccine on day 0, and placebo on day 28
Biological: Licensed COVID-19 vaccine
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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older 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 (phase Ib only).
  3. Male and female adults aged 18 and above (phase IIa) at time of informed consent.
  4. Phase IIa: Either in good or stable health in the opinion of the investigator. Participants may have underlying illness as long as their symptoms are medically controlled, and they are on a stable medication for the respective underlying illness for at least 8 weeks before screening and no changes are expected dur-ing the study.
  5. Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
  6. Female participants: non-pregnant, non-lactating with negative pregnancy test.
  7. Females who agree to comply with the applicable contraceptive requirements of the protocol.
  8. Documented previous SARS-CoV-2 infection (PCR-positive) OR documented vaccination against SARS-CoV-2 with (conditionally) licensed vaccine against COVID-19, at least 6 months prior to in-clusion into this study. (phase IIa open-label 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 phase IIa open-label exploratory study).
  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 allergy to the components of the comparator vaccine (phase IIa Part A).
  8. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
  9. 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.
  10. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
  11. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
  12. 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


Contacts
Layout table for location contacts
Contact: Marylyn M Addo, MD +49 407410 ext 0 m.addo@uke.de

Locations
Layout table for location information
Germany
CTC North Recruiting
Hamburg, Germany, 20251
Contact: Marylyn M Addo, MD         
Sub-Investigator: Anahita Fathi, MD         
Sub-Investigator: Anastasia Kelidou, MD         
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
Layout table for investigator information
Principal Investigator: Marylyn M Addo, MD Universitätsklinikum Hamburg-Eppendorf
Layout table for additonal information
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: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
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