CureVac has started dosing participants in a Phase IIa clinical trial of its messenger RNA (mRNA)-based Covid-19 vaccine candidate, CVnCoV.
The dose-confirmation study, CV-NCOV-002, is being carried out in Peru and Panama. It will enrol 690 healthy participants across adults aged 61 or above and those aged 18-60.
Each participant will be administered with two CVnCoV vaccines, 28 days apart.
The study will test different dose levels, starting from 6µg. The goal is to analyse the safety and reactogenicity of the vaccine in older adults.
Furthermore, the humoral immune response with CVnCoV will be evaluated and the safety database will be expanded to progress into a Phase IIb/III trial.
Preliminary Phase IIa results in older adults are expected to be reported in the fourth quarter of the year.
The Phase IIa trial is based on initial safety and immunogenicity findings from the vaccine candidate’s ongoing Phase I CV-NCOV-001 study in Germany and Belgium.
CureVac chief technology officer Dr Mariola Fotin-Mleczek said: “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.”
With further data of the ongoing Phase I and Phase IIa studies yet to be reported, CureVac plans to launch a Phase IIb/III trial in about 30,000 volunteers globally in the fourth quarter of this year.
In a separate development, Moderna has published the second interim analysis report of the open-label Phase I trial of its Covid-19 vaccine candidate, mRNA-1273, in The New England journal of Medicine.
Data showed that the two-dose schedule of mRNA-1273 triggered high levels of pseudovirus neutralisation antibody titres in all participants, including older adults.