Clinical-stage biopharma company CureVac has announced the initiation of Phase III clinical study of its Covid-19 vaccine, CVnCoV, in healthcare workers at the University Medical Center Mainz, Germany.
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 clinical Phase III study aims to analyse the safety and immunogenicity of CVnCoV given as a two-dose schedule of 12µg.
The 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.
It complements another global pivotal Phase IIb/III HERALD trial of CVnCoV, which began recently, in more than 35,000 participants.
CureVac Infectious Diseases head Dr Lidia Oostvogels said: “With this clinical study in healthcare workers, we aim to investigate the difference our vaccine candidate can make in this specific group of individuals who are at particularly high risk of potential infection due to viral exposure.
“Based on this trial, we hope to gain additional insights for effective prevention of Covid-19 in this vulnerable population.”
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 (epidemiology) 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.
Last month, CureVac 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.