MOSQUIRIX: JOURNEY FROM LAB TO PHASE 3 CLINICAL TRIALS

*Kapil Dhiman, Shilpa Chandel and Dr. Bharat Parashar

ABSTRACT

Background: Malaria is the major public health threat in endemic regions. However, the recent advances in control efforts has reduced the burden of malaria to some extent but it is still responsible for vast number of deaths in other African countries. RTS, S/AS01 provides active immunization against the most vulnerable group i.e. infants and children aged 6 weeks to 17 months. Development of Mosquirix was a long process with difficulties in identifying malaria antigen related to the induction of immune responses and development of adjuvant system. Main body: Mosquirix was approved by European medicine agency in July 2015 and WHO launched pilot project in three malaria endemic countries in 2019. Phase 3 clinical trial suggested that it only provides partial protection against malaria infection in infant and children and considering the high burden of disease it is currently considered for use in malaria endemic countries.Currently GSK is planning Phase IV studies for identification of rare adverse events by a well-planned pharmacovigilance system. Safety profile of vaccine is acceptable but there is risk of convulsions after third dose of vaccine. Conclusion: From clinical trial the vaccine efficacy for phase 1, 2 and 3 was found 28.60%, 45% and 39% respectively. The 4-dose regimen of RTS, S has been found efficacious and provide greatest protection among infants and children. RTS,S/AS01E believe to shows promise results as a candidate malaria vaccine.

Keywords: Malaria, Mosquirix, RTS, S/AS01, Endemic.