In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-SARS-2-S. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S). A total of 30 participants will receive the following vaccine regime: 15 participants will receive 10\^7 infectious units (IU) of MVA-SARS-2-S on days 0 and 28. 15 participants will receive 10\^8 IU of MVA-SARS-2-S on days 0 and 28. Safety and immunogenicity data will be collected throughout the study, which concludes at day 168. A subgroup will receive a heterologous booster vaccination with a licensed COVID-19 vaccine. Vaccinees will receive two doses of the Comirnaty vaccine (21 days interval).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Vaccination with MVA-SARS-2-S in two escalating dose regimens
Vaccination with Comirnaty (21 day interval)
CTC North GmbH & Co KG at the University Medical Center Hamburg-Eppendorf
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)
Immunogenicity. Number of participants who seroconverted
Magnitude of SARS-CoV2-specific antibody responses (ELISA and neutralization assays) monitored in an approved laboratory
Time frame: during the entire study (up to 6 months)
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