COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults
NCT ID: NCT05950776
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-01-15
2022-11-02
Brief Summary
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The aim of the study is to assess the safety and immunogenicity of the candidate vaccine.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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
PREVENTION
TRIPLE
Study Groups
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1x10E7 IU (low dose)
1x10E7 IU MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28)
MVA-SARS-2-S
Vaccination with MVA-SARS-2-S
1x10E8 IU (high dose)
1x10E8 MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28)
MVA-SARS-2-S
Vaccination with MVA-SARS-2-S
Placebo
Days 0 \& 28
Placebo
Placebo
Interventions
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MVA-SARS-2-S
Vaccination with MVA-SARS-2-S
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Body mass index 18.5 - 32.0 kg/m2 and weight \> 50 kg at screening.
5. Non-pregnant, non-lactating female with negative pregnancy test.
6. Females who agree to comply with the applicable contraceptive requirements of the protocol.
Exclusion Criteria
2. Previous rMVA immunization.
3. Evidence of an active SARS-CoV-2 infection.
4. 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.
5. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
6. 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.
7. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
8. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c \> 7.0).
9. Any known chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child.
18 Years
ALL
Yes
Sponsors
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German Center for Infection Research
OTHER
Philipps University Marburg
OTHER
Ludwig-Maximilians - University of Munich
OTHER
University Hospital Tuebingen
OTHER
CTC-NORTH
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Marylyn M Addo, MD
Role: PRINCIPAL_INVESTIGATOR
CTC-NORTH
Other Identifiers
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UKE-SARS-COV-2-II
Identifier Type: -
Identifier Source: org_study_id
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