Covid19
Conditions
Keywords
MVA, vaccine, SARS-CoV-2
Brief 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.
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).
Interventions
BIOLOGICALMVA-SARS-2-S
Vaccination with MVA-SARS-2-S
OTHERPlacebo
Placebo
Sponsors
German Center for Infection Research
Philipps University Marburg
Ludwig-Maximilians - University of Munich
University Hospital Tuebingen
CTC-NORTH
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-blind: two or more parties are unaware of the intervention assignment.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent. 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
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | during the entire study (up to 6 months) | Number of participants who seroconverted. Magnitude of SARS-CoV-2 specific antibody responses (ELISA and neutralization assay) |
Outcome results
None listed