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Vaccine Detail

RTS,S/AS01E
Vaccine Information
  • Vaccine Name: RTS,S/AS01E
  • Target Pathogen: Plasmodium spp.
  • Target Disease: Malaria
  • Type: Subunit vaccine
  • Status: Clinical trial
  • Host Species for Licensed Use: Human
  • Antigen: RTS,S is the pre-erythrocyte sporozoite-stage Plasmodium falciparum antigen. It is a circumsporozoite surface protein (Alonso et al., 2004)
  • Immunization Route: Intramuscular injection (i.m.)
  • Description: Developed for immunization of infants in Africa, the RTS,S/ AS01E vaccine uses RTS,S, the P. falciparum circumsporite surface protein with AS01E as the vaccine adjuvant. AS01E contains 50% less liposome-based formulation of MPL and QS-21 compared to AS01B. (Asante et al., 2011)
Host Response

Human Response

  • Host Strain: Children 6-10 weeks of age at first vaccination
  • Vaccination Protocol: Children receive three doses of RTS,S/AS01(E) at 6, 10, and 14 weeks (0, 1, 2 month schedule) or at 6 weeks, 10 weeks, and 9 months (0, 2, 7 month schedule) or placebo.(Asante et al., 2011)
  • Immune Response: At month 19, anticircumsporozoite immune responses were significantly higher in the RTS,S/AS01(E) groups than in the control group. (Asante et al., 2011)
  • Efficacy: For the entire study period, (total vaccinated cohort) vaccine efficacy against all malaria episodes was higher with the 0, 1, 2 month schedule (57%, 95% CI 33-73; p=0·0002) than with the 0, 1, 7 month schedule (32% CI 16-45; p=0·0003).(Asante et al., 2011)
References
Alonso et al., 2004: Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Milman J, Mandomando I, Spiessens B, Guinovart C, Espasa M, Bassat Q, Aide P, Ofori-Anyinam O, Navia MM, Corachan S, Ceuppens M, Dubois MC, Demoitie MA, Dubovsky F, Menendez C, Tornieporth N, Ballou WR, Thompson R, Cohen J. Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet. 2004 Oct 16-22; 364(9443); 1411-20. [PubMed: 15488216].
Asante et al., 2011: Asante KP, Abdulla S, Agnandji S, Lyimo J, Vekemans J, Soulanoudjingar S, Owusu R, Shomari M, Leach A, Jongert E, Salim N, Fernandes JF, Dosoo D, Chikawe M, Issifou S, Osei-Kwakye K, Lievens M, Paricek M, Möller T, Apanga S, Mwangoka G, Dubois MC, Madi T, Kwara E, Minja R, Hounkpatin AB, Boahen O, Kayan K, Adjei G, Chandramohan D, Carter T, Vansadia P, Sillman M, Savarese B, Loucq C, Lapierre D, Greenwood B, Cohen J, Kremsner P, Owusu-Agyei S, Tanner M, Lell B. Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial. The Lancet. Infectious diseases. 2011; 11(10); 741-749. [PubMed: 21782519].