Covid19 Clinical Trial
Official title:
An Open, Single-center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-SARS-2-S and Heterologous Booster Vaccinations With a Licensed Vaccine Against COVID-19
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). ;
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