The dose-escalation trial will enrol up to 180 healthy adult subjects who are Covid-19-vaccinated.
To be carried out in clinical sites in the US, UK, Philippines, and Australia, the trial will assess the safety, reactogenicity, and immunogenicity of a CV0501 booster in dosages ranging between 12µg-50µg.
On reporting safety and immunogenicity data at these dose levels, the company might assess vaccine dose levels below 12µg and above 50µg.
This trial comes after another Phase I study was launched in March this year to analyse CV2CoV, an unmodified second-generation Covid-19 vaccine candidate.
The comprehensive way to assess an unmodified and a modified, second-generation Covid-19 vaccine candidate is anticipated to detect the best candidate for late-stage clinical trials.
The CV0501 vaccine is developed by the company in partnership with GSK.
It is based on the second-generation mRNA backbone of CureVac and can offer protection against the Omicron variant.
CureVac interim chief development officer Dr Ulrike Gnad-Vogt said: “Licensed Covid-19 vaccines that encode for the original virus variant continue to protect against severe disease and hospitalisation, but they are increasingly challenged by immune evasion of new variants such as Omicron.
“As we extend the clinical studies of our second-generation backbone into modified mRNA, targeting the Omicron variant will further explore the full potential of our improved second-generation design as a booster vaccination for a relevant variant.”
In February this year, the company dosed the first subject in a Phase I trial of its second-generation mRNA seasonal influenza vaccine candidate, CVSQIV.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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