Today, CureVac announced that it has begun it’s COVID-19 clinical trial in the Phase 2b/3 stage for drug candidate CVnCoV. 36,500 patients are enrolled and the trial will collect data to support approval of the mRNA vaccine.
With BioNTech, Pfizer and Moderna’s approval and validation of such vaccine by the FDA, grants CureVac similar leeway. The idea of using mRNA to provide protection against SARS-CoV-2, rapidly delivering stellar efficacy results that set a high bar for the rest of the field. CureVac has taken a slightly different approach to mRNA vaccines, choosing to use the potency of untranslated regions to optimize the RNA rather than make chemical modifications.
This approach has allowed CureVac to create a candidate that triggers immune responses at a 12-µg dose, compared to the 100 µg used by Moderna. That will enable CureVac to make more doses of the vaccine. CureVac is also aiming to trigger balanced immune responses.
CureVac is now putting its approach to the ultimate test. The phase 2b portion of the clinical trial will randomize 4,000 subjects across two age cohorts—18 to 60 years and 61 years and older—to take two doses of CVnCoV or placebo four weeks apart. Around 800 to 1,000 of the participants will be aged 61 years and older.
The phase 2b trial will generate safety, reactogenicity and immunogenicity data to inform the start of the phase 3. Once 1,000 subjects have at least one week of follow-up after the first vaccination, the Data and Safety Monitoring Board will review the data and make a decision on the phase 3.
CureVac plans to move seamlessly into the phase 3 clinical trial if the data support the larger study. The phase 3 study will recruit 32,500 subjects. CureVac plans to pool data from the phase 2b and 3 portions of the clinical trial.