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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
43
i.m. vaccine administration
Uniklinik Köln
Cologne, North Rhine-Westphalia, Germany
CTC North
Hamburg, Germany
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.
Time frame: during the entire study (up to 6 months)
Number of participants who seroconverted
Magnitude of SARS-CoV-2-S specific antibody responses will be measured by ELISA and neutralization assays
Time frame: during the entire study (up to 6 months)
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