From research to phase III: Preclinical, industrial and clinical development of the Sanofi Pasteur tetravalent dengue vaccine

Development of Sanofi Pasteur tetravalent dengue vaccine

“…These include live attenuated virus (LAV), recombinant virus vectors expressing dengue envelope (E) antigens, purified inactivated virus (PIV), recombinant subunit vaccine, virus-like particles (VPLs), and DNA vaccines [6][7][8] .…”

“…Each recombinant virus (CYD1, CYD2, CYD3 and CYD4) was constructed by removing the genes encoding the premembrane (prM) and envelope (E) proteins from the yellow fever 17D virus and inserting the corresponding genes from a dengue virus 8 . Using this technology, Sanofi Pasteur has preclinically, clinically and industrially developed a tetravalent dengue vaccine, combining the four CYD vaccine viruses into a single vaccine.…”

“…Using this technology, Sanofi Pasteur has preclinically, clinically and industrially developed a tetravalent dengue vaccine, combining the four CYD vaccine viruses into a single vaccine. This dengue candidate vaccine is the first to reach the milestone of clinical phase III studies 8 .…”

“…How to fit a new vaccine into existing national immunization programs therefore requires careful consideration. It is therefore necessary to study the potential of interference of a dengue vaccine candidate when co-administered with established vaccines 7,8 .…”

“…Other challenges relate to the industrialization of vaccine production for the four vaccine viruses, and the manufacturing process scale-up necessary to supply large-scale Phase III trials to demonstrate the protective efficacy, and to prepare for the subsequent launch in case of licensure [7][8][9][10] . Sanofi Pasteur has constructed new facilities to scale up the production, and facilitate supply and access to vaccine as soon as possible 8 .…”