A Phase 1, partially blind, placebo-controlled, dose-escalation, first-in-human, clinical trial to evaluate the safety, reactogenicity and immunogenicity after 1 and 2 doses of the investigational SARS-CoV-2 mRNA vaccine CVnCoV administered intramuscularl

In partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), CureVac AG is developing a new SARS-CoV-2 (mRNA) vaccine formulated with lipid nanoparticles (referred to as CVnCoV). This first-in-human (FIH) Phase 1 trial will evaluate the safety, reactogenicity and immunogenicity of CVnCoV at different dose levels using an adaptive dose-finding design.
This will allow dose escalation or de-escalation using predefined safety criteria and select the CVnCoV dose for further clinical development.

Projektziele

1) To evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.

2) To evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV at different dose levels.

3) To evaluate the cell-mediated immune response after 1 and 2 dose administrations of CVnCoV at different dose levels in all subjects from the assigned site(s).

4) To evaluate the innate immune response after 1 and 2 dose administrations of CVnCoV at different dose levels in all open-label sentinel subjects. 

5) To identify and assess cases of COVID-19 disease.

6) To describe the rate of asymptomatic infections with SARS-CoV-2.

 

Projektlaufzeit: 06/2020 bis 12/2021

 

Peter.kremsner@uni-tuebingen.de
ClinicalTrials.gov