Covid19Phase 2NCT05950776
COVID-19 Trial of the Candidate Vaccine MVA-SARS-2-S in Adults
A Phase 2 study testing MVA-SARS-2-S in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
In this multi-center phase II clinical trial, adults in stable health conditions will be vaccinated twice with either a low dose or high dose of the candidate vaccine MVA-SARS-2-S, or placebo. The aim of the study is to assess the safety and immunogenicity of the candidate vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- MVA-SARS-2-S
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 2 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent.
- 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.
- 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.
- Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
- Non-pregnant, non-lactating female with negative pregnancy test.
- Females who agree to comply with the applicable contraceptive requirements of the protocol.
Who cannot join
- 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.
- Evidence of an active SARS-CoV-2 infection.
- 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.
- Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
- 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.
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- Clinically relevant findings in ECG or significant thromboembolic events in medical history.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c > 7.0).
- Any known chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child.
About this study
Official title: A Multi-center, Randomized Placebo-controlled Phase II Trial to Assess the Safety, Tolerability and Immunogenicity of Two Doses of the Candidate Vaccine MVA-SARS-2-S in Adults Aged 18 to 64 and 65 and Older
In this multi-center phase II clinical trial, adults in stable health conditions will be vaccinated twice with either a low dose or high dose of the candidate vaccine MVA-SARS-2-S, or placebo.
The aim of the study is to assess the safety and immunogenicity of the candidate vaccine.
Read the detailed description
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S).
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
- Covid19
- Being tested
- MVA-SARS-2-S, Placebo
- Keywords
- MVA, vaccine, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-SARS-2-SBiological
Vaccination with MVA-SARS-2-S
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1x10E7 IU (low dose) | Experimental | 1x10E7 IU MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28) Receives: Biological: MVA-SARS-2-S |
| 1x10E8 IU (high dose) | Experimental | 1x10E8 MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28) Receives: Biological: MVA-SARS-2-S |
| Placebo | Placebo comparator | Days 0 \& 28 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the entire study (up to 6 months)
Secondary outcomes (1)
Immunogenicity
Number of participants who seroconverted. Magnitude of SARS-CoV-2 specific antibody responses (ELISA and neutralization assay)
Measured: during the entire study (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start15 Jan 2021
- Primary completion2 Nov 2022 (estimated)
- Study completion2 Nov 2022 (estimated)
Why it stopped: Results from Phase 1 lead to the decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Male and female individuals in stable health conditions (group I and II, see below) will be stratified for age and included to the following groups with a random allocation to one of the two dose groups 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 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research, Philipps University Marburg, Ludwig-Maximilians - University of Munich, University Hospital Tuebingen, CTC-NORTH
- Responsible party
- Sponsor
- Investigators
- Marylyn M Addo, MD, Principal investigator, CTC-NORTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950776
- Sponsor's protocol ID
- UKE-SARS-COV-2-II
- Status last verified
- Jun 2023
- First submitted
- 23 Jan 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Placebo-controlled Phase II Trial to Assess the Safety, Tolerability and Immunogenicity of Two Doses of the Candidate Vaccine MVA-SARS-2-S in Adults Aged 18 to 64 and 65 and Older
- ClinicalTrials.gov ID
- NCT05950776
- Acronym / sponsor ID
- UKE-SARS-COV-2-II
- Conditions
- Covid19
- Keywords
- MVA, vaccine, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Results from Phase 1 lead to the decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Center for Infection Research, Philipps University Marburg, Ludwig-Maximilians - University of Munich, University Hospital Tuebingen, CTC-NORTH
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 2 Nov 2022 (estimated)
- Study completion
- 2 Nov 2022 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this multi-center phase II clinical trial, adults in stable health conditions will be vaccinated twice with either a low dose or high dose of the candidate vaccine MVA-SARS-2-S, or placebo.
The aim of the study is to assess the safety and immunogenicity of the candidate vaccine.
Detailed description
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S).
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Male and female individuals in stable health conditions (group I and II, see below) will be stratified for age and included to the following groups with a random allocation to one of the two dose groups 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 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
| Arm | Type | Receives |
|---|---|---|
| 1x10E7 IU (low dose) | Experimental | Biological: MVA-SARS-2-S1x10E7 IU MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28) |
| 1x10E8 IU (high dose) | Experimental | Biological: MVA-SARS-2-S1x10E8 MVA-SARS-2-S Intervention: Biological: MVA-SARS-2-S vaccinations (days 0 \& 28) |
| Placebo | Placebo comparator | Other: PlaceboDays 0 \& 28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent.
- 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.
- 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.
- Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
- Non-pregnant, non-lactating female with negative pregnancy test.
Key exclusion criteria (9 listed)
- 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.
- Evidence of an active SARS-CoV-2 infection.
- 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.
- Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA-SARS-2-SVaccination with MVA-SARS-2-S | Biological | 1x10E7 IU (low dose), 1x10E8 IU (high dose) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Immunogenicity
Time frame: during the entire study (up to 6 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marylyn M Addo, MD principal investigator
CTC-NORTH
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-SARS-2-S in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.