Clinical trial NCT04895449: Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19
Official title: A Multi-center Phase Ib Trial to Assess the Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Keywords: MVA
SARS-CoV-2
vaccine
booster vaccination
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Center for Infection Research
name: Philipps University Marburg
name: Ludwig-Maximilians - University of Munich
name: IDT Biologika
name: Clinical Trial Center North (CTC North GmbH & Co. KG)
First posted: 2021-05-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).

Detailed description: The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized SARS-CoV-2 spike protein (S).

This will be a phase Ib multi-center study in approximately 60 adults aged 18-64 years.

Part A (N=24 seronegative subjects). Each participant will receive two single injections, 28 days apart.

* low dose ≥ 1 x 10e7 IU (N=8)
* middle dose ≥ 5 x 10e7 IU (N=8)
* high dose ≥ 1 x 10e8 IU (N=8)

Part B (N=36 previously mRNA vaccinated subjects). Each participant will receive a single injection.

* low dose ≥ 1 x 10e7 IU (N=12)
* middle dose ≥ 5 x 10e7 IU (N=12)
* high dose ≥ 1 x 10e8 IU (N=12)

All participants will be followed up for safety until D168.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent.
2. Healthy male and female adults aged 18 - 64 at time of informed consent.
3. Body mass index 18.5 - 32.0 kg/m2 and weight \> 50 kg at screening.
4. Female participants: non-pregnant, non-lactating with negative pregnancy test.
5. Females who agree to comply with the applicable contraceptive requirements of the protocol.
6. ≥ 6 months fully vaccinated with a (conditionally)licensed mRNA vaccine against COVID-19 (Part B only)

Exclusion Criteria:

1. Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
2. Previous rMVA immunization.
3. Previous immunization with investigational vaccine against COVID-19.
4. Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
5. Evidence of active SARS-CoV-2 infection
6. Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
7. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
8. 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.
9. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
10. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
11. Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Primary outcomes:
measure: Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
timeFrame: during the entire study (up to 6 months)
Secondary outcomes:
measure: Number of participants who seroconverted
timeFrame: during the entire study (up to 6 months)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Uniklinik Köln
state: NRW
city: Hamburg
country: Germany
facility: CTC North
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Marylyn M Addo, MD
role: PRINCIPAL_INVESTIGATOR
References: