CureVac has initiated a phase III clinical trial of its COVID-19 vaccine candidate, CVnCoV, in healthcare workers at the University Medical Center Mainz, Germany. The study aims to analyse the safety and immunogenicity of CVnCoV given as a two-dose schedule of 12µg.
CVnCoV is an optimised, non-chemically modified mRNA, encoding the prefusion stabilised full-length spike protein of the SARS-CoV-2.
The randomised, observer-blind, placebo-controlled study will enrol more than 2,500 participants aged 18 years or above. They will be randomised into this study out of the non-interventional trial. The trial complements another global pivotal phase IIb/III HERALD trial of CVnCoV, which began recently, in more than 35,000 participants.
The latest trial comes after an epidemiological, non-interventional study on healthcare workers from the University Hospital in Mainz. It enrolled 3,600 hospital employees and also includes medicine and dentistry students.
The ongoing study is analysing the distribution of COVID-19 in a collective of hospital employees. It focuses on the rate at which SARS-CoV-2-specific antibodies arise and can be identified in hospital employees as well as the frequency of virologically confirmed COVID-19 cases in them.
CureVac, in November, had reported that the ongoing phase I study of CVnCoV showed that it was well-tolerated across all tested doses ranging from 2µg to 12µg and induced strong binding and neutralising antibody responses.