This study is designed to evaluate the safety, tolerability and reactogenicity of intramuscular dose administrations of: -3 dose levels of the MVA-SARS-2-ST vaccine in healthy SARS-CoV-2 seronegative adults (2 administrations) (Part A). -1 dose level of the MVA-SARS-2-ST vaccine in healthy adults with previous mRNA vaccination against COVID-19 (1 administration) (Part B).
Conditions
Interventions
Product Name: MVA-SARS-2-ST
Product Code: MVA-SARS-2-S
Pharmaceutical Form: Solution for injection
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
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 (positive SARS-CoV-2 antigen test followed by a confirmatory positive PCR test). 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). 12.Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the safety, tolerability and reactogenicity of two intramuscular dose administrations of three dose levels of the candidate MVA-SARS-2-ST vaccine in healthy SARS-CoV-2 seronegative adults aged 18-64 years (Part A). •To evaluate the safety, tolerability and reactogenicity of one intramuscular dose administration of three dose levels of the candidate MVA-SARS-2-ST vaccine in healthy adults previously vaccinated against COVID-19 aged 18-64 years (Part B). ;Secondary Objective: •To evaluate SARS-CoV-2-S1-binding and SARS-CoV-2 neutralizing antibodies in healthy SARS-CoV-2 seronegative adults induced by three dose levels after two administrations of MVA-SARS-2-ST vaccine ( Part A). •To evaluate SARS-CoV-2-S1-binding and SARS-CoV-2 neutralizing antibodies in healthy adults vaccinated against COVID-19 induced by three dose levels after one administrations of MVA-SARS-2-ST vaccine (Part B). ;Primary end point(s): The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST vaccine;Timepoint(s) of evaluation of this end point: •Occurrence of solicited local reactogenicity signs and symp-toms for 7 days after vaccination. •Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days after vaccination. •Occurrence of unsolicited adverse events (AE) for 28 days after vaccination. •Change from baseline of safety laboratory measures. •Occurrence of serious adverse events (SAE) throughout the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity •Humoral immunity: Magnitude of anti-SARS-CoV-2-S antibody responses (Part A and B). •Percentage of participants who seroconverted (Part A). •Percentage of participants who showed an increase of the level of binding and neutralizing antibodies to baseline (Part B). ;Timepoint(s) of evaluation of this end point: Magnitude of anti-SARS-CoV-2-S antibody responses on day 7, 14, 28, 35, 42, 56, 84, 168 (Part A)/ on day 7, 14, 28, 56, 168 (Part B) | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
University Medical Center Hamburg-Eppendorf
Outcome results
None listed