CureVac announces start of Phase 1/2 study in avian influenza

CureVac (CVAC) announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A pre-pandemic vaccine candidate developed in collaboration with GSK (GSK). The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based on CureVac’s proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen. The combined Phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of an investigational influenza A pre-pandemic vaccine candidate in healthy younger adults aged 18 to 64 and healthy older adults aged 65 to 85. In the initial Phase 1 dose-escalation part of the study, up to five dose levels will be assessed compared to a placebo control. The study will be conducted in the United States. The broad CureVac-GSK infectious disease collaboration was first announced in July 2020. It focuses on applying CureVac’s mRNA-technology to the development of new products for infectious disease targets.