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Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569383
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : November 5, 2021
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

Study Description
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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. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine.

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) Biological: Comirnaty 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.

A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. Vaccinees will receive two doses of the Comirnaty vaccine (21 days interval).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 and Heterologous Booster Vaccinations With a Licensed Vaccine Against COVID-19
Actual Study Start Date : October 5, 2020
Actual Primary Completion Date : August 24, 2021
Actual Study Completion Date : August 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1x10E7 IU (low dose)
1x10E7 IU MVA-SARS-2-S. Subgroup will receive additionally Comirnaty
 Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
Vaccination with MVA-SARS-2-S in two escalating dose regimens

Biological: Comirnaty
Vaccination with Comirnaty (21 day interval)
Experimental: 1x10E8 IU (high dose)
1x10E8 MVA-SARS-2-S. Subgroup will receive additionally Comirnaty
 Biological: MVA-SARS-2-S vaccinations (days 0 & 28)
Vaccination with MVA-SARS-2-S in two escalating dose regimens

Biological: Comirnaty
Vaccination with Comirnaty (21 day interval)


Outcome Measures
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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


Eligibility Criteria
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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

Inclusion criteria for the subjects before the 3rd/4th (=booster) vaccination:

  1. Ability to understand the subject information and to personally name, sign and date the in-formed consent to participate in the study.
  2. Provided written informed consent.
  3. Continues to be in stable health condition as determined during medical history and physi-cal examination on vaccination visits.
  4. Non-pregnant, non-lactating female with a negative pregnancy test at screening and on dosing days (prior to vaccination).
  5. Be willing to refrain from blood donation during the course of the study.
  6. The subject is co-operative and available for the entire study.
  7. Need to have participated in previous part of the MVA-SARS-2-S vaccine study (Eudra-CT No: 2020-002998-10)

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

Exclusion criteria for the subjects before the 3rd/4th (=booster) vaccination:

  1. Prior infection with SARS-CoV-2 in medical history (documented by PCR test)
  2. Receipt of any vaccine from 2 weeks prior to each trial vaccination (4 weeks for live vac-cines) to 2 weeks after each trial vaccination.
  3. Receipt any COVID-19 vaccine (investigational or licensed other than MVA-SARS-2-S be-fore vaccination throughout end of study).
  4. Known allergy to the components of t Comirnaty®.
  5. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
  6. Participation in a clinical trial other than the MVA-SARS-2-S vaccine trial or use of an in-vestigational product other than MVA-SARS-2-S within 30 days or five times the half-life of the investigational product -whichever is longer- prior to receiving the first dose within this study.
  7. Evidence in the subject's medical history or in the medical examination that might influence
Contacts and Locations
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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


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
More Information
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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: November 5, 2021
Last Verified: November 2021

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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
mRNA vaccine
heterologous
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases