The randomized and placebo-controlled trial called Herald may include more than 35,000 participants in Europe and Latin America, the Tübingen-based company announced. It added that the first participant has been enrolled in the pivotal study of a mRNA vaccine candidate, CvnCoV.
“With the start of the pivotal Phase 2b/3 study, we have reached another important milestone in the development of our vaccine candidate,” CEO of CureVac Dr. Franz-Werner Haas said, adding that the clinical safety and immunogenicity data achieved to date look promising. “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.”
Subjects 18 years of age or older will be enrolled at multiple sites, and they will receive a two-dose schedule of either SARS-CoV-2 or placebo.
CureVac plans to demonstrate the efficacy of CVnCoV in preventing first episodes of confirmed cases of coronavirus, and preventing moderate to severe confirmed cases in participants who have never been infected. The participants will continue to be monitored in a one-year extension study after the trial.
The company began to develop a vaccine candidate in January 2020, with the compound being an optimized, non-chemically modified mRNA. CureVac encodes the prefusion stabilized full-length spike protein of the virus.
Phase 1 and 2a clinical trials began in June and September, respectively. Phase 1 interim data in November showed that CVnCoV was “generally well tolerated across all tested doses and induced strong antibody responses,” the company said.
In mid-November, the European Commission announced a supply agreement with CureVac for 405 million doses of the vaccine for EU member states.
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