CureVac NV announced that the first participant in a clinical phase 3 study with its COVID-19 vaccine, CVnCoV, in healthcare workers at the University Medical Center Mainz will be vaccinated on December 22, 2020. The study aims to evaluate the safety and immunogenicity of CVnCoV administered as a two-dose schedule of 12 µg. The trial follows an epidemiological, non-interventional study conducted with healthcare workers from the University Hospital in Mainz.
“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,” Dr. Lidia Oostvogels, Head of Infectious Diseases of CureVac, said in a company news release. “Based on this trial, we hope to gain additional insights for effective prevention of COVID-19 in this vulnerable population.”
The randomized, observer blind, placebo-controlled clinical phase 3 study will include more than 2,500 subjects, 18 years of age and older, who will be randomized into this study out of the non-interventional trial. It complements the recent initiation of CureVacs global pivotal Phase 2b/3 trial, HERALD, for CVnCoV in more than 35,000 participants.
The phase 3 study builds on a non-interventional study on COVID-19 at the University Hospital Mainz involving 3,600 hospital employees, including medicine and dentistry students in their 5th semester or higher. The study has been ongoing for several months and investigates the distribution (epidemiology) of COVID-19 in a collective of employees of a University Hospital. It focuses on the rate at which SARS-CoV-2-specific antibodies arise and can be detected in hospital employees as well as the frequency of virologically confirmed COVID-19 cases in this cohort of hospital employees.