By combining the RSV-specific antigen, F-protein in prefusion conformation, with an adjuvant system (AS01E), adjuvanted RSVPreF3 vaccine is designed to enhance antigen-specific cellular immune response and neutralizing antibodies response in individuals with pre-existing immunity against RSV. The adjuvant AS01E facilitates the recruitment and activation of antigen presenting cells carrying vaccine-derived antigens in the draining lymph node, which in turn leads to the generation of RSVPreF3-specific CD4+ T cells.
Not applicable.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Reproductive and developmental studies with an unadjuvanted RSVPreF3 vaccine as well as results from a study with adjuvanted RSVPreF3 vaccine in rabbits did not reveal vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development.
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