CureVac N.V. commences global pivotal phase IIb/III trial for COVID-19 vaccine candidate, CVnCoV.

CureVac N.V. announced that it has enrolled the first participant in the pivotal Phase IIb/III study of its mRNA vaccine candidate, CVnCoV, against COVID-19 The randomized, observer blind, placebo-controlled Phase IIb/III trial called HERALD will assess the safety and efficacy of CVnCoV in adults at a dose of 12 µg. The study is expected to include more than 35,000 participants at sites in Europe and Latin America. The HERALD trial will start with an initial Phase IIb part, which is expected to seamlessly merge into a Phase III efficacy trial. Subjects 18 years of age or older will be enrolled at multiple sites and will receive a two-dose schedule of either CVnCoV 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 with SARS-CoV-2. Efficacy of CVnCoV will be assessed by an event-driven analysis based on a certain number of participants who present with laboratory confirmed symptomatic COVID-19 disease during the study. To ensure continued and close safety monitoring of the participants in the trial, data will be reviewed by an independent Data Safety Monitoring Board on a regular basis.Following completion of the trial, subjects will continue to be monitored in a 1-year extension study . The extension study will collect additional data 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. If all goes well in its pivotal HERALD trial, the vaccine could gain emergency use authorizations by Q2 2021.