This will be a phase I, single-center trial, including a total of 30 participants in two cohorts. Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen. Cohort 2 (n=24): Healthy male or female adults aged 18 - ≤ 60 primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen and subsequently booster immunized with any EU marketed mRNA vaccine Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
23
In this trial MVA-SARS-2-ST will be used. Each vial contains 1 x 107 IU/dose MVA-SARS-2-ST in 0.5 mL as active ingredient. The solution will be used for nebulization and direct administration to the respiratory tract.
Hannover Medical School ZKS - Early Clinical Trial Unit at CRC Hannover
Hanover, Germany
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 0
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 1
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 2
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 3
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 4
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 5
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 6
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: day 7
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by spirometry as forced vital capacity (FVC) (%)
Time frame: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by spirometry as forced expiratory volume in 1 second (FEV1) (%)
Time frame: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by spirometry as FEV1/FVC (%)
Time frame: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by peak flow as peak expiratory flow (PEF) frequently
Time frame: day 0 and twice daily on days 1, 2, 3, 4, 5, 6, 7
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 0
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 1
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 2
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 3
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 4
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 5
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 6
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Time frame: day 7
Occurrence of unsolicited adverse events (AE) associated with MVA-SARS-2-ST
Occurrence of unsolicited adverse events (AE)
Time frame: from day 0 to day 28 after vaccination
Change of safety laboratory measures associated with MVA-SARS-2-S
Change from baseline of safety laboratory measures
Time frame: day 1, 3, 7, 14, 28, 56, 140
Occurrence of serious adverse events (SAE) associated with MVA-SARS-2-ST
Occurrence of serious adverse events (SAE)
Time frame: through study completion, an average of 5 month
To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Change from baseline of levels of binding antibodies against SARS-CoV-2 spike S1 protein measured by ELISA in blood
Time frame: day 7, 14, 28, 56 and 140
To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Change from baseline of levels of binding antibodies against SARS-CoV-2 spike S1 protein measured by ELISA in (bronchial alveolar lavage) BAL on day 14
Time frame: day 14
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