Covid19Phase 1NCT04569383
Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19
A Phase 1 study testing MVA-SARS-2-S vaccinations (days 0 & 28) and Comirnaty in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- MVA-SARS-2-S vaccinations (days 0 & 28) and Comirnaty
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 5 Oct 2020to 24 Aug 2021
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
CTC North GmbH & Co KG at the University Medical Center Hamburg-Eppendorf
Hamburg, 20251
About this study
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
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.
Read the 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).
- Conditions
- Covid19
- Being tested
- MVA-SARS-2-S vaccinations (days 0 & 28), Comirnaty
- Keywords
- MVA, vaccine, SARS-CoV-2, mRNA vaccine, heterologous
- 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-S vaccinations (days 0 & 28)Biological
Vaccination with MVA-SARS-2-S in two escalating dose regimens
ComirnatyBiological
Vaccination with Comirnaty (21 day interval)
| Study group | Role | What they receive |
|---|---|---|
| 1x10E7 IU (low dose) | Experimental | 1x10E7 IU MVA-SARS-2-S. Subgroup will receive additionally Comirnaty Receives: Biological: MVA-SARS-2-S vaccinations (days 0 & 28); Biological: Comirnaty |
| 1x10E8 IU (high dose) | Experimental | 1x10E8 MVA-SARS-2-S. Subgroup will receive additionally Comirnaty Receives: Biological: MVA-SARS-2-S vaccinations (days 0 & 28); Biological: Comirnaty |
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-CoV2-specific antibody responses (ELISA and neutralization assays) monitored in an approved laboratory
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 posted29 Sep 2020
- Study start5 Oct 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- Responsible party
- Sponsor
- Investigators
- Marylyn M Addo, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569383
- Sponsor's protocol ID
- UKE-DZIF-SARS-CoV-2
- Status last verified
- Nov 2021
- First submitted
- 21 Sep 2020
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grewe I, Friedrich M, Dieck ML, Spohn M, Ly ML, Krahling V, Mayer L, Mellinghoff SC, Rottstegge M, Kraemer R, Volz A, Becker S, Fathi A, Dahlke C, Weskamm LM, Addo MM. MVA-based SARS-CoV-2 vaccine candidates encoding different spike protein conformations induce distinct early transcriptional responses which may impact subsequent adaptive immunity. Front Immunol. 2024 Dec 19;15:1500615. doi: 10.3389/fimmu.2024.1500615. eCollection 2024.
PubMed 39749328
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04569383
- Acronym / sponsor ID
- UKE-DZIF-SARS-CoV-2
- Conditions
- Covid19
- Keywords
- MVA, vaccine, SARS-CoV-2, mRNA vaccine, heterologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Center for Infection Research, Philipps University Marburg, Ludwig-Maximilians - University of Munich
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 29 Sep 2020 (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 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1x10E7 IU (low dose) | Experimental | Biological: MVA-SARS-2-S vaccinations (days 0 & 28), Biological: Comirnaty1x10E7 IU MVA-SARS-2-S. Subgroup will receive additionally Comirnaty |
| 1x10E8 IU (high dose) | Experimental | Biological: MVA-SARS-2-S vaccinations (days 0 & 28), Biological: Comirnaty1x10E8 MVA-SARS-2-S. Subgroup will receive additionally Comirnaty |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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-S vaccinations (days 0 & 28)Vaccination with MVA-SARS-2-S in two escalating dose regimens | Biological | 1x10E7 IU (low dose), 1x10E8 IU (high dose) |
| ComirnatyVaccination with Comirnaty (21 day interval) | Biological | 1x10E7 IU (low dose), 1x10E8 IU (high dose) |
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. Number of participants who seroconverted
Time frame: during the entire study (up to 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Derived from this study: PubMed 39749328Grewe I, Friedrich M, Dieck ML, Spohn M, Ly ML, Krahling V, Mayer L, Mellinghoff SC, Rottstegge M, Kraemer R, Volz A, Becker S, Fathi A, Dahlke C, Weskamm LM, Addo MM. MVA-based SARS-CoV-2 vaccine candidates encoding different spike protein conformations induce distinct early transcriptional responses which may impact subsequent adaptive immunity. Front Immunol. 2024 Dec 19;15:1500615. doi: 10.3389/fimmu.2024.1500615. eCollection 2024.
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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
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA-SARS-2-S vaccinations (days 0 & 28) and Comirnaty in people with Covid19, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 14 inclusion and 17 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: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT04569383, which also lists 1 linked publication.
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 5 Nov 2021.