Drug intelligence / Profile preview

RTS,S + AS01E

Development stage
Unknown
Lead developer
GSK
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

RTS,S + AS01E is a recombinant protein-based malaria vaccine, marketed as Mosquirix, designed to prevent malaria caused by *Plasmodium falciparum*, the most deadly and prevalent malaria parasite in Africa. The vaccine consists of two main components: 1. **RTS,S** – a recombinant antigen combining part of the *P. falciparum* circumsporozoite protein (CSP) fused to hepatitis B surface antigen (HBsAg), which enhances immunogenicity. 2. **AS01E** – an adjuvant system containing monophosphoryl lipid A (MPL) and QS21 formulated in liposomes, boosting immune response. The mechanism involves inducing high titers of anti-CSP antibodies and cellular immune responses that block the parasite from infecting liver cells after mosquito transmission, thereby preventing progression to symptomatic blood-stage infection[5][7]. The vaccine is administered in a four-dose schedule starting at around 5 months of age[3][4]. It has demonstrated moderate efficacy (~36% over 4 years with four doses) against clinical malaria in children aged 5–17 months and reduces severe cases and hospitalizations[1][2][4]. Developed through collaboration between GlaxoSmithKline (GSK), PATH Malaria Vaccine Initiative, with support from the Bill & Melinda Gates Foundation, it was first recommended by WHO for use in children at risk of *P. falciparum* malaria in October 2021[3][4][5]. Manufacturing responsibilities are transitioning from GSK to Bharat Biotech for large-scale production; GSK continues supplying the adjuvant component[7].

Brand names
Mosquirix
Other names
RTS,S malaria vaccineGSK3980514AGSK-3980514AGSK 3980514A
02

Targets

CSP (Circumsporozoite protein)

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