CureVac commences global mid-stage trial for COVID-19 vaccine candidate

 

• CureVac (NASDAQ:CVAC) has enrolled the first participant in the pivotal Phase 2b/3 study of its mRNA vaccine candidate, CVnCoV, against COVID-19.
• The trial called HERALD will assess the safety and efficacy of CVnCoV in adults at a dose of 12 µg and is expected to include more than 35,000 participants at sites in Europe and Latin America. Subjects 18 years of age or older will receive a two-dose schedule of either SARS-CoV-2 or placebo.
• Besides the primary safety objective, the study design includes two primary efficacy objectives: the demonstration of the efficacy of CVnCoV in preventing first episodes of confirmed cases of COVID-19 of any severity, as well as preventing moderate to severe confirmed cases of COVID-19 in participants who have never been infected.
• The data will be reviewed by an independent Data Safety Monitoring Board on a regular basis.
• The subjects will continue to be monitored in a 1-year extension study to evaluate long-term safety, persistence of antibodies to SARS-CoV-2 and the occurrence of COVID-19 cases to assess the duration of vaccine efficacy.
• https://seekingalpha.com/news/3643919-curevac-commences-global-mid-stage-trial-for-covidminus-19-vaccine-candidate