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Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S Against COVID-19

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: NCT04569383
Recruitment Status : Not yet recruiting
First Posted : September 29, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
German Center for Infection Research
Philipps University Marburg Medical Center
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date  ICMJE September 21, 2020
First Posted Date  ICMJE September 29, 2020
Last Update Posted Date September 29, 2020
Estimated Study Start Date  ICMJE October 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
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 No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
Immunogenicity. Number of participants who seroconverted [ Time Frame: during the entire study (up to 6 months) ]
Magnitude of SARS-CoV2-specific antibody responses (ELISA and neutralization assays) monitored in an approved laboratory
Original Secondary Outcome Measures  ICMJE Same as current
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-S Against COVID-19
Official Title  ICMJE An Open, Single-center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-SARS-2-S
Brief Summary

In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S.

The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

Detailed Description

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S). A total of 30 participants will receive the following vaccine regime:

15 participants will receive 10^7 infectious units (IU) of MVA-SARS-2-S on days 0 and 28.

15 participants will receive 10^8 IU of MVA-SARS-2-S on days 0 and 28. Safety and immunogenicity data will be collected throughout the study, which concludes at day 168.

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-S vaccinations (days 0 & 28)
Vaccination with MVA-SARS-2-S in two escalating dose regimens
Study Arms  ICMJE
  • Experimental: 1x10E7 IU (low dose)
    1x10E7 IU MVA-SARS-2-S
    Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
  • Experimental: 1x10E8 IU (high dose)
    1x10E8 MVA-SARS-2-S
    Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent
  • Healthy male and female adults aged 18-55 years
  • No clinically significant health problems as determined during medical history and physical examination at screening visit
  • Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening
  • Adults male or non-pregnant, non-lactating female with negative pregnancy test
  • Males and females who agree to comply with the applicable contraceptive requirements of the protocol

Exclusion Criteria:

  • Prior exposure to SARS-CoV-2
  • 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
  • Known allergy to the components of the SARS-CoV-2 vaccine product
  • Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine
  • Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product
  • Clinically relevant findings in ECG
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes
  • Any 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 55 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 NCT04569383
Other Study ID Numbers  ICMJE UKE-DZIF-SARS-CoV-2
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 Not Provided
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
Investigators  ICMJE
Principal Investigator: Marylyn M Addo, MD Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date September 2020

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