CureVac doses first patient in Phase 2 study of COVID-19 vaccine candidates

CureVac announced that the first participant was dosed in the Phase 2 study of monovalent and bivalent modified mRNA COVID-19 vaccine candidates, developed in collaboration with GSK. A first data read-out of the study is expected early in the first half of 2024. The Phase 2 study will evaluate safety, reactogenicity and immune responses of single booster doses of two modified mRNA COVID-19 vaccine candidates. The monovalent candidate, CV0601, encodes the spike protein of the omicron BA.4-5 variant. In line with the current standard of care, the bivalent candidate, CV0701, encodes the spike protein of the omicron BA.4-5 variant as well as the original SARS-CoV-2 strain. The study is active-controlled, featuring a licensed bivalent COVID-19 comparator vaccine. Enrollment started at clinical sites in Australia. The study is expected to enroll approximately 415 healthy adult participants. As previously reported, in CureVac and GSK’s ongoing Phase 1 trial of CV0501, a monovalent, modified mRNA COVID-19 vaccine candidate encoding the spike protein of the omicron BA.1 variant, preliminary data showed a favorable tolerability profile. Preliminary immunogenicity data indicated relevant ratios of post-boost to pre-boost neutralizing antibody titers beginning at the lowest tested dose. The CureVac-GSK COVID-19 collaboration was first announced in February 2021 and focuses on the development and manufacturing of potential vaccines against SARS-CoV-2 variants to address current healthcare needs and help prepare against future SARS-CoV-2 outbreaks.