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COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MVA-SARS-2-S
Placebo
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, vaccine, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Written informed consent. Male and female adults in stable health conditions aged 18 - 64 at time of informed consent (participation of health care workers and risk groups will be prioritized) and male or female in stable health conditions aged ≥ 65 at time of informed consent. 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 during the study. Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening. Non-pregnant, non-lactating female with negative pregnancy test. Females who agree to comply with the applicable contraceptive requirements of the protocol. 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. Evidence of an active SARS-CoV-2 infection. Known allergy to the components of the MVA-SARS-2-S vaccine product such as chicken proteins, 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 vaccine. 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 under investigation. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1x10E7 IU (low dose)

    1x10E8 IU (high dose)

    Placebo

    Arm Description

    1x10E7 IU MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)

    1x10E8 MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)

    Days 0 & 28

    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

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

    Full Information

    First Posted
    January 23, 2021
    Last Updated
    July 17, 2023
    Sponsor
    Universitätsklinikum Hamburg-Eppendorf
    Collaborators
    German Center for Infection Research, Philipps University Marburg Medical Center, Ludwig-Maximilians - University of Munich, University Hospital Tuebingen, CTC-NORTH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05950776
    Brief Title
    COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults
    Official Title
    A Multi-center, Randomized Placebo-controlled Phase II Trial to Assess the Safety, Tolerability and Immunogenicity of Two Doses of the Candidate Vaccine MVA-SARS-2-S in Adults Aged 18 to 64 and 65 and Older
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Results from Phase 1 lead to the decision
    Study Start Date
    January 15, 2021 (Actual)
    Primary Completion Date
    November 2, 2022 (Anticipated)
    Study Completion Date
    November 2, 2022 (Anticipated)

    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, University Hospital Tuebingen, CTC-NORTH

    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
    In this multi-center phase II clinical trial, adults in stable health conditions will be vaccinated twice with either a low dose or high dose of the candidate vaccine MVA-SARS-2-S, or placebo. The aim of the study is to assess the safety and immunogenicity of the candidate vaccine.
    Detailed Description
    The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S). This will be a combined Phase II, multi-center trial in a total of 580 participants. The dose finding study will be conducted randomized-controlled, in adults in stable health conditions, including health care workers, COVID-19 risk populations, individuals with advanced age and seropositive individuals. Male and female individuals in stable health conditions will be stratified for age (18-64 years and 65 and older).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Male and female individuals in stable health conditions (group I and II, see below) will be stratified for age and included to the following groups with a random allocation to one of the two dose groups or the placebo in a 4:4:1 ratio: 1 x 107 ± 0.5 log IU MVA-SARS-2-S 1 x 108 ± 0.5 log IU MVA-SARS-2-S Placebo Male and female individuals in stable health conditions will be stratified for age and randomized to low dose, hogh dose of MVA SARS-2-S or the placebo in a 4:4:1 ratio: 1 x 107 ± 0.5 log IU MVA-SARS-2-S 1 x 108 ± 0.5 log IU MVA-SARS-2-S Placebo
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Double-blind: two or more parties are unaware of the intervention assignment.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1x10E7 IU (low dose)
    Arm Type
    Experimental
    Arm Description
    1x10E7 IU MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
    Arm Title
    1x10E8 IU (high dose)
    Arm Type
    Experimental
    Arm Description
    1x10E8 MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Days 0 & 28
    Intervention Type
    Biological
    Intervention Name(s)
    MVA-SARS-2-S
    Intervention Description
    Vaccination with MVA-SARS-2-S
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    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
    Immunogenicity
    Description
    Number of participants who seroconverted. Magnitude of SARS-CoV-2 specific antibody responses (ELISA and neutralization assay)
    Time Frame
    during the entire study (up to 6 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Written informed consent. Male and female adults in stable health conditions aged 18 - 64 at time of informed consent (participation of health care workers and risk groups will be prioritized) and male or female in stable health conditions aged ≥ 65 at time of informed consent. 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 during the study. Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening. Non-pregnant, non-lactating female with negative pregnancy test. Females who agree to comply with the applicable contraceptive requirements of the protocol. 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. Evidence of an active SARS-CoV-2 infection. Known allergy to the components of the MVA-SARS-2-S vaccine product such as chicken proteins, 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 vaccine. 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 under investigation. 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
    CTC-NORTH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults

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