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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

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.


Condition or disease Intervention/treatment Phase
Covid19 Biological: MVA-SARS-2-S vaccinations (days 0 & 28) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: 1x10E7 IU (low dose)
1x10E7 IU MVA-SARS-2-S
Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
Vaccination with MVA-SARS-2-S in two escalating dose regimens

Experimental: 1x10E8 IU (high dose)
1x10E8 MVA-SARS-2-S
Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
Vaccination with MVA-SARS-2-S in two escalating dose regimens




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. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04569383


Contacts
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Contact: Marylyn M Addo, MD +49 407410 ext 0 m.addo@uke.de

Locations
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Germany
CTC North GmbH & Co KG at the University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20251
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Center for Infection Research
Philipps University Marburg Medical Center
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: Marylyn M Addo, MD Universitätsklinikum Hamburg-Eppendorf
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04569383    
Other Study ID Numbers: UKE-DZIF-SARS-CoV-2
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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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
vaccine
SARS-CoV-2
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs