• Vaccine Name: RTS,S/AS01
• Target Pathogen: Plasmodium spp.
• Target Disease: Malaria
• Tradename: Mosquirix
• Vaccine Ontology ID: VO_0003093
• Type: Subunit vaccine
• Status: Licensed
• Host Species for Licensed Use: Human
• Antigen: RTS,S: fragment of circumsporozoite protein of the pre-erythrocyte sporozoite-stage P.falciparum(Laurens, 2020)
• CS from P. falciparum gene engineering:
  • Type: Recombinant protein preparation
  • Description: Part of CSP from P. falciparum: 18 NANP repeats and C-terminus exclusive of GPI sequence(Laurens, 2020)
  • Detailed Gene Information: Click Here.
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0005358
  • Description: combination of liposome, MPL, and QS-21(Laurens, 2020)
• Immunization Route: Intramuscular injection (i.m.)

Human Response

• Host Strain: children aged 5-17 months and infants aged 6-12 weeks from sub-Saharan African countries
• Vaccination Protocol: Double-blinded, phaseIII, randomised controlled trial.
  Participants were randomly assigned in a 1:1:1 ration to receive 1) three doses of RTS,S/AS01 at month 0, 1, and 2 and a booster dose at month 20; 2) three doses of RTS,S/AS01 at month 0, 1, and 2 and a dose of control at month 20; or 3) four doses of control at month 0, 1, 2, and 20.
  (Laurens, 2020)
• Immune Response: The vaccine induces and increases anti-CSP antibody levels and CD4+ T cell responses.
  Older children have greater protective immune response than infants, and children received booster have greater protective immune response than children who did not. Children aged 5-17 months received booster dose had 318.3 EU/mL anti-CSP antibody after a month and 52.4 EU/mL after a year, and children did not receive the booster had 34.2 EU/mL after a month and 19.3 EU/mL after a year. Infants aged 6-12 weeks received booster dose had 169.9 EU/mL after a month and 15.9 EU/mL after a year, and infants did not receive the booster had 6.2 EU/mL after a month and 3.7 EU/mL after a year. (Laurens, 2020)
• Side Effects: Increased risk of febrile seizures: children aged 5-17 months more likely to have febrile seizures within 7 days after vaccination than controls. All affected children recovered after 7 days.(Laurens, 2020)
• Efficacy: Efficacy against clinical malaria in 12 months after dose 3: 31.3% (97.5%CI 23.6-38.3%, p< .0001) for 6-12 weeks age and 55.8% (97.5%CI 50.6-60.4%, p< .0001) for 5-17 months age
  Additional efficacy against clinical malaria at the end of follow-up: booster dose group: 25.9% for 6-12 weeks age and 36.3% for 5-17 months age; 3 doses group: 18.3% for 6-12 weeks age and 28.3% for 5-17 months age.
  Additional efficacy against severe malaria at the end of follow-up: booster dose group: 17.3% for 6-12 weeks age and 32.2% for 5-17 months age; 3 doses group: 10.3% for 6-12 weeks age and 1.1% for 5-17 months age. (Laurens, 2020)