German company CureVac has enrolled the first participant in the pivotal Phase IIb/III HERALD study to evaluate the safety and efficacy of its mRNA vaccine candidate, CVnCoV, against Covid-19.
The randomised, observer-blind, placebo-controlled trial will evaluate CVnCoV at a dose of 12µg in adults and plans to enrol over 35,000 subjects at sites in Europe and Latin America.
CureVac CEO Dr Franz-Werner Haas said: “With the start of the pivotal Phase IIb/III study, we have reached another important milestone in the development of our vaccine candidate, CVnCoV.
“The clinical safety and immunogenicity data achieved to date look promising and we are hopeful that this trial will continue to demonstrate the impact of mRNA technology and our vaccine to prevent Covid-19, and to help defeat this pandemic.”
Initially, the trial will begin with Phase IIb segment and will merge into the Phase III efficacy trial.
In the trial, adult participants enrolled at multiple sites will be administered two-doses of either CVnCoV or placebo intramuscularly on day one and 29.
Apart from the primary safety objective, the study design has two primary efficacy objectives.
They include demonstration of the vaccine efficacy in preventing first episodes of confirmed Covid-19 cases of any severity and preventing moderate to severe cases in SARS-CoV-2 naïve subjects.
In addition, the efficacy of CVnCoV will be analysed by an event-driven analysis based on a fixed number of subjects who present with laboratory tested symptomatic Covid-19 during the trial.
On concluding the Phase IIb/III trial, participants will be monitored for one year as part of the extension study.
In July, the European Investment Bank (EIB) and European Commission agreed to provide CureVac with a €75m funding for the ongoing infectious disease vaccine programmes, including its Covid-19 vaccine candidate.