Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19
Primary Purpose
Covid19
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
MVA-SARS-2-S vaccinations (days 0 & 28)
Comirnaty
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring MVA, vaccine, SARS-CoV-2, mRNA vaccine, heterologous
Eligibility 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:
- Ability to understand the subject information and to personally name, sign and date the in-formed consent to participate in the study.
- Provided written informed consent.
- Continues to be in stable health condition as determined during medical history and physi-cal examination on vaccination visits.
- Non-pregnant, non-lactating female with a negative pregnancy test at screening and on dosing days (prior to vaccination).
- Be willing to refrain from blood donation during the course of the study.
- The subject is co-operative and available for the entire study.
- 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:
- Prior infection with SARS-CoV-2 in medical history (documented by PCR test)
- 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.
- Receipt any COVID-19 vaccine (investigational or licensed other than MVA-SARS-2-S be-fore vaccination throughout end of study).
- Known allergy to the components of t Comirnaty®.
- Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
- 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.
- Evidence in the subject's medical history or in the medical examination that might influence
Sites / Locations
- CTC North GmbH & Co KG at the University Medical Center Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1x10E7 IU (low dose)
1x10E8 IU (high dose)
Arm Description
1x10E7 IU MVA-SARS-2-S. Subgroup will receive additionally Comirnaty
1x10E8 MVA-SARS-2-S. Subgroup will receive additionally Comirnaty
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-CoV2-specific antibody responses (ELISA and neutralization assays) monitored in an approved laboratory
Full Information
NCT ID
NCT04569383
First Posted
September 21, 2020
Last Updated
November 4, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Center for Infection Research, Philipps University Marburg Medical Center, Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT04569383
Brief Title
Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)
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
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 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.
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).
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, mRNA vaccine, heterologous
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1x10E7 IU (low dose)
Arm Type
Experimental
Arm Description
1x10E7 IU MVA-SARS-2-S. Subgroup will receive additionally Comirnaty
Arm Title
1x10E8 IU (high dose)
Arm Type
Experimental
Arm Description
1x10E8 MVA-SARS-2-S. Subgroup will receive additionally Comirnaty
Intervention Type
Biological
Intervention Name(s)
MVA-SARS-2-S vaccinations (days 0 & 28)
Intervention Description
Vaccination with MVA-SARS-2-S in two escalating dose regimens
Intervention Type
Biological
Intervention Name(s)
Comirnaty
Intervention Description
Vaccination with Comirnaty (21 day interval)
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. Number of participants who seroconverted
Description
Magnitude of SARS-CoV2-specific antibody responses (ELISA and neutralization assays) monitored in an approved laboratory
Time Frame
during the entire study (up to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
Ability to understand the subject information and to personally name, sign and date the in-formed consent to participate in the study.
Provided written informed consent.
Continues to be in stable health condition as determined during medical history and physi-cal examination on vaccination visits.
Non-pregnant, non-lactating female with a negative pregnancy test at screening and on dosing days (prior to vaccination).
Be willing to refrain from blood donation during the course of the study.
The subject is co-operative and available for the entire study.
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:
Prior infection with SARS-CoV-2 in medical history (documented by PCR test)
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.
Receipt any COVID-19 vaccine (investigational or licensed other than MVA-SARS-2-S be-fore vaccination throughout end of study).
Known allergy to the components of t Comirnaty®.
Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
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.
Evidence in the subject's medical history or in the medical examination that might influence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marylyn M Addo, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
CTC North GmbH & Co KG at the University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19
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