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Vaccine Profile

The RTS,S vaccine candidate for malaria

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Pages 589-599 | Published online: 09 Jan 2014

References

  • WHO. Impact of Malaria Control. In: World Malaria Report 2010. WHO Press, Geneva, Switzerland, 39–62 (2010).
  • WHO. Impact of Malaria Control. In: World Malaria Report 2009. WHO Press, Geneva, Switzerland, 27–44 (2009).
  • Snow RW, Craig MH, Newton CR, Steketee RW. The public health burden of Plasmodium falciparum malaria in Africa. Working Paper 11. Disease Control Priorities Project, Bethesda, MD, USA (2003).
  • Nussenzweig RS, Vanderberg J, Most H, Orton C. Protective immunity produced by the injection of x-irradiated sporozoites of Plasmodium berghei. Nature216(5111), 160–162 (1967).
  • Clyde DF. Immunization of man against falciparum and vivax malaria by use of attenuated sporozoites. Am. J. Trop. Med. Hyg.24(3), 397–401 (1975).
  • Clyde DF, McCarthy VC, Miller RM, Hornick RB. Specificity of protection of man immunized against sporozoite-induced falciparum malaria. Am. J. Med. Sci.266(6), 398–403 (1973).
  • Yoshida N, Nussenzweig RS, Potocnjak P, Nussenzweig V, Aikawa M. Hybridoma produces protective antibodies directed against the sporozoite stage of malaria parasite. Science207(4426), 71–73 (1980).
  • Potocnjak P, Yoshida N, Nussenzweig RS, Nussenzweig V. Monovalent fragments (Fab) of monoclonal antibodies to a sporozoite surface antigen (Pb44) protect mice against malarial infection. J. Exp. Med.151(6), 1504 (1980).
  • Dame J, Williams J, McCutchan T et al. Structure of the gene encoding the immunodominant surface antigen on the sporozoite of the human malaria parasite Plasmodium falciparum. Science225(4662), 593–599 (1984).
  • Rutgers T, Gordon D, Gathoye AM et al. Hepatitis B surface antigen as carrier matrix for the repetitive epitope of the circumsporozoite protein of Plasmodium falciparum. Nat. Biotech.6(9), 1065–1070 (1988).
  • Vreden SGS, Verhave JP, Oettinger T, Sauerwein RW, Meuwissen J. Phase I clinical trial of a recombinant malaria vaccine consisting of the circumsporozoite repeat region of Plasmodium falciparum coupled to hepatitis B surface antigen. Am. J. Trop. Med. Hyg.45(5), 533 (1991).
  • Gordon DM, McGovern TW, Krzych U et al. Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium falciparum circumsporozoite protein–hepatitis B surface antigen subunit vaccine. J. Infect. Dis.171(6), 1576–1585 (1995).
  • Stoute JA, Slaoui M, Heppner DG et al. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N. Engl. J. Med.336(2), 86 (1997).
  • Bojang KA, Milligan PJ, Pinder M et al. Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet358(9297), 1927–1934 (2001).
  • Lambrecht BN, Kool M, Willart MA, Hammad H. Mechanism of action of clinically approved adjuvants. Curr. Opin. Immunol.21(1), 23–29 (2009).
  • Sun HX, Xie Y, Ye YP. Advances in saponin-based adjuvants. Vaccine27(12), 1787–1796 (2009).
  • Kool M, Soullie T, van Nimwegen M et al. Alum adjuvant boosts adaptive immunity by inducing uric acid and activating inflammatory dendritic cells. J. Exp. Med.205(4), 869–882 (2008).
  • Tritto E, Mosca F, De Gregorio E. Mechanism of action of licensed vaccine adjuvants. Vaccine27(25–26), 3331–3334 (2009).
  • Fox CB, Friede M, Reed SG, Ireton GC. Synthetic and natural TLR4 agonists as safe and effective vaccine adjuvants. Subcell. Biochem.53, 303–321 (2010).
  • Vandepapelière P, Horsmans Y, Moris P et al. Vaccine adjuvant systems containing monophosphoryl lipid A and QS21 induce strong and persistent humoral and T cell responses against hepatitis B surface antigen in healthy adult volunteers. Vaccine26(10), 1375–1386 (2008).
  • Rhee EG, Kelley RP, Agarwal I et al. TLR4 ligands augment antigen-specific CD8+ T lymphocyte responses elicited by a viral vaccine vector. J. Virol.84(19), 10413–10419 (2010).
  • Alderson MR, McGowan P, Baldridge JR, Probst P. TLR4 agonists as immunomodulatory agents. J. Endotoxin Res.12(5), 313–319 (2006).
  • Morefield GL, Hawkins LD, Ishizaka ST, Kissner TL, Ulrich RG. Synthetic Toll-like receptor 4 agonist enhances vaccine efficacy in an experimental model of toxic shock syndrome. Clin. Vaccine Immunol.14(11), 1499–1504 (2007).
  • Morel S, Didierlaurent A, Bourguignon P et al. Adjuvant System AS03 containing α-tocopherol modulates innate immune response and leads to improved adaptive immunity. Vaccine29(13), 2461–2473 (2011).
  • Vogel FR, Caillet C, Kusters IC, Haensler J. Emulsion-based adjuvants for influenza vaccines. Expert Rev. Vaccines8(4), 483–492 (2009).
  • Coler RN, Carter D, Friede M, Reed SG. Adjuvants for malaria vaccines. Parasite Immunol.31(9), 520–528 (2009).
  • Garçon N, Chomez P, Van Mechelen M. GlaxoSmithKline Adjuvant Systems in vaccines: concepts, achievements and perspectives. Expert Rev. Vaccines6(5), 723–739 (2007).
  • Stoute JA, Kester KE, Krzych U et al. Long-term efficacy and immune responses following immunization with the RTS,S malaria vaccine. J. Infect. Dis.178(4), 1139–1144 (1998).
  • Kester KE, McKinney DA, Tornieporth N et al. Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J. Infect. Dis.183(4), 640–647 (2001).
  • Kester KE, McKinney DA, Tornieporth N et al. A Phase I/IIa safety, immunogenicity, and efficacy bridging randomized study of a two-dose regimen of liquid and lyophilized formulations of the candidate malaria vaccine RTS,S/AS02A in malaria-naive adults. Vaccine25(29), 5359–5366 (2007).
  • Kester KE, Cummings JF, Ockenhouse CF et al. Phase 2a trial of 0, 1, and 3 month and 0, 7, and 28 day immunization schedules of malaria vaccine RTS,S/AS02 in malaria-naive adults at the Walter Reed Army Institute of Research. Vaccine26(18), 2191–2202 (2008).
  • Sun P, Schwenk R, White K et al. Protective immunity induced with malaria vaccine, RTS,S, is linked to Plasmodium falciparum circumsporozoite protein-specific CD4+ and CD8+ T cells producing IFN-γ. J. Immunol.171(12), 6961–6967 (2003).
  • Stewart V, Walsh DS, McGrath SM et al. Cutaneous delayed-type hypersensitivity (DTH) in a multi-formulation comparator trial of the anti-falciparum malaria vaccine candidate RTS,S in rhesus macaques. Vaccine24(42–43), 6493–6502 (2006).
  • Stewart V, McGrath SM, Walsh DS et al. Pre-clinical evaluation of new adjuvant formulations to improve the immunogenicity of the malaria vaccine RTS,S/AS02A. Vaccine24(42–43), 6483–6492 (2006).
  • Mettens P, Dubois PM, Demoitié MA et al. Improved T cell responses to Plasmodium falciparum circumsporozoite protein in mice and monkeys induced by a novel formulation of RTS,S vaccine antigen. Vaccine26(8), 1072–1082 (2008).
  • Kester K, Cummings J, Ofori-Anyinam O et al. Randomized, double-blind, Phase 2a trial of falciparum malaria vaccines RTS,S/AS01B and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J. Infect. Dis.200(3), 337–346 (2009).
  • Doherty JF, Pinder M, Tornieporth N et al. A Phase I safety and immunogenicity trial with the candidate malaria vaccine RTS,S/SBAS2 in semi-immune adults in The Gambia. Am. J. Trop. Med. Hyg.61(6), 865–868 (1999).
  • Stoute JA, Heppner D Jr, Mason CJ et al. Phase 1 safety and immunogenicity trial of malaria vaccine RTS,S/AS02A in adults in a hyperendemic region of Western Kenya. Am. J. Trop. Med. Hyg.75(1), 166–170 (2006).
  • Heppner DG, Cummings JF, Ockenhouse CF, Kester KE. New generation vaccines. In: New Generation Vaccines. Marcel Dekker, Inc., New York, NY, USA, 851–859 (2004).
  • Polhemus ME, Remich SA, Ogutu BR et al. Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. PLoS ONE4(7), e6465 (2009).
  • Bojang KA, Olodude F, Pinder M et al. Safety and immunogenicty of RTS,S/AS02A candidate malaria vaccine in Gambian children. Vaccine23(32), 4148–4157 (2005).
  • Macete E, Aponte JJ, Guinovart C et al. Safety and immunogenicity of the RTS,S/AS02A candidate malaria vaccine in children aged 1–4 in Mozambique. Trop. Med. Int. Health12(1), 37–46 (2007).
  • Alonso PL, Sacarlal J, Aponte JJ et al. Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet364(9443), 1411–1420 (2004).
  • Alonso PL, Sacarlal J, Aponte JJ et al. Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. Lancet366(9502), 2012–2018 (2005).
  • Guinovart C, Aponte JJ, Sacarlal J et al. Insights into long-lasting protection induced by RTS,S/AS02A malaria vaccine: further results from a Phase IIb trial in Mozambican children. PLoS ONE4(4), e5165 (2009).
  • Sacarlal J, Aide P, Aponte J et al. Long term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. J. Infect. Dis.200(3), 329–336 (2009).
  • Aponte JJ, Aide P, Renom M et al. Safety of the RTS,S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled Phase I/IIb trial. Lancet370(9598), 1543–1551 (2007).
  • Abdulla S, Oberholzer R, Juma O et al. Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. N. Engl. J. Med.359(24), 2533–2544 (2008).
  • Lell B, Agnandji S, von Glasenapp I et al. A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon. PLoS ONE4(10), e7611 (2009).
  • Owusu-Agyei S, Ansong D, Asante K et al. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS ONE4(10), e7302 (2009).
  • Bejon P, Lusingu J, Olotu A et al. Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N. Engl. J. Med.359(24), 2521–2532 (2008).
  • Olotu A, Lusingu J, Leach A et al. Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5–17 months in Kenya and Tanzania: a randomised controlled trial. Lancet Infect. Dis.11(2), 102–109 (2011).
  • Agnandji ST, Asante KP, Lyimo J et al. Evaluation of the safety and immunogenicity of the RTS,S/AS01E malaria candidate vaccine when integrated in the expanded program of immunization. J. Infect. Dis.202(7), 1076–1087 (2010).
  • Cummings J, Polhemus M, Kester K et al. Safety, immunogenicity, and efficacy of candidate malaria vaccine containing CSP and MSP-1 antigens. Presented at: 51st Annual Meeting of the American Society of Tropical Medicine and Hygiene. Denver, CO, USA, 10–14 November 2002.
  • Kester K, Heppner D, Ockenhouse C et al. Double-blind, randomized Phase I/IIa trial of SmithKline Beecham’s candidate malaria vaccines RTS,S+TRAP and TRAP. Presented at: Molecular Approaches to Malaria. Erskine House, Lorne, Victoria, Australia (2000).
  • Pichyangkul S, Kum-Arb U, Yongvanitchit K et al. Peclinical evaluation of the safety and immunogenicity of a vaccine consisting of Plasmodium falciparum liver-stage antigen 1 with adjuvant AS01B administered alone or concurrently with the RTS,S/AS01B vaccine in rhesus primates. Infect. Immun.76(1), 229–238 (2007).
  • Epstein JE, Charoenvit Y, Kester KE et al. Safety, tolerability, and antibody responses in humans after sequential immunization with a PfCSP DNA vaccine followed by the recombinant protein vaccine RTS,S/AS02A. Vaccine22(13–14), 1592–1603 (2004).
  • Wang R, Epstein J, Charoenvit Y et al. Induction in humans of CD8+ and CD4+ T cell and antibody responses by sequential immunization with malaria DNA and recombinant protein. J. Immunol.172(9), 5561–5569 (2004).
  • Dunachie SJ, Walther M, Vuola JM et al. A clinical trial of prime–boost immunisation with the candidate malaria vaccines RTS,S/AS02A and MVA-CS. Vaccine24(15), 2850–2859 (2006).
  • Stewart VA, McGrath SM, Dubois PM et al. Priming with an adenovirus 35-circumsporozoite protein (CS) vaccine followed by RTS,S/AS01B boosting significantly improves immunogenicity to Plasmodium falciparum CS compared to that with either malaria vaccine alone. Infect. Immun.75(5), 2283–2290 (2007).
  • Rodríguez A, Mintardjo R, Tax D et al. Evaluation of a prime–boost vaccine schedule with distinct adenovirus vectors against malaria in rhesus monkeys. Vaccine27(44), 6226–6233 (2009).
  • Draper SJ, Biswas S, Spencer AJ et al. Enhancing blood-stage malaria subunit vaccine immunogenicity in rhesus macaques by combining adenovirus, poxvirus, and protein-in-adjuvant vaccines. J. Immunol.185(12), 7583–7595 (2010).

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