Phase 2 study initiated at clinical sites in Australia with monovalent and bivalent mRNA COVID-19 vaccine candidates
Vaccine candidates developed in collaboration with GSK within COVID-19 vaccine development program. (Credit: CureVac SE)
CureVac, a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today 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.
“COVID-19 remains a global health threat and, accordingly, there is an enduring need for a vaccination strategy that will also ensure most vulnerable populations, such as the elderly and immunocompromised, are optimally protected. Moreover, it is vitally important that we continue to refine our understanding of coronavirus vaccines in the event of a future pandemic,” said Dr. Myriam Mendila, Chief Development Officer of CureVac. “We are confident that we can harness the potential of our clinically validated second-generation mRNA backbone to support the clinical development of differentiated COVID-19 vaccine candidates, as the rapid pace of vaccine development in the pandemic-era left substantial opportunity to improve.”
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.
Source: Company Press Release