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The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.
CureVac, a clinical-stage biopharmaceutical company, announced on Sept. 29, 2020 that its first participant has been dosed with its COVID-19 vaccine candidate, CVnCoV, in a Phase IIa clinical trial.
According to a company press release, the study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old. The participants will receive two vaccinations over the course of 28 days, starting at 6 μg to determine reactogenicity of the vaccine in older adults. The study will measure the humoral immune response after administration of CVnCoV to make preparations for the start of a phase IIb/III study.
The study is based off of preliminary safety and immunogenicity data from CureVac's ongoing Phase 1 CV-NCOV-001 study in Germany and Belgium, the press release said. The company plans to launch a Phase IIb/III clinical trial enrolling 30,000 participants in the fourth quarter of 2020.
"The start of the clinical Phase IIa trial in Peru and Panama represents an important step forward in our COVID-19 clinical study program," said Dr. Mariola Fotin-Mleczek, chief technology officer of CureVac, in the press release. "This trial is designed to further confirm the selection of the dose of our vaccine candidate and to confirm that we can provide a safe and tolerable vaccine, also to older adults, who are at a higher risk of experiencing serious impacts from COVID-19.”