Reducing empiricism in malaria vaccine design

The Lancet Infectious Diseases

Volumn 10, Issue 3, 2010, Pages 204-211

  Moorthy, Vasee S ^a,b   Kieny, Marie Paule ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

^b UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADJUVANT; DNA 18S; ERYTHROCYTE ANTIGEN; IMMUNOGLOBULIN G; MALARIA VACCINE; MEROZOITE SURFACE PROTEIN 1;

ARTICLE; CD4+ T LYMPHOCYTE; CELLULAR IMMUNITY; DNA POLYMORPHISM; DRUG DESIGN; DRUG EFFICACY; EMPIRICISM; GROWTH INHIBITION; HUMAN; MALARIA; NONHUMAN; PARASITE ISOLATION; PARASITEMIA; PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; POLYMERASE CHAIN REACTION; PREDICTIVE VALIDITY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SPOROZOITE; STANDARDIZATION;

EID: 76849095373     PISSN: 14733099     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1473-3099(09)70329-9     Document Type: Note

References (62)

1. WHO. World Malaria Report 2008 (2008), World Health Organization, Geneva. http://www.who.int/malaria/publications/atoz/9789241563697/en/index.html (accessed Jan 26, 2010).
2. Hay S.I., Smith D.L., and Snow R.W. Measuring malaria endemicity from intense to interrupted transmission. Lancet Infect Dis 8 (2008) 369-378
3. Sachs J., and Malaney P. The economic and social burden of malaria. Nature 415 (2002) 680-685
4. Snow R.W., Trape J.F., and Marsh K. The past, present and future of childhood malaria mortality in Africa. Trends Parasitol 17 (2001) 593-597
5. WHO. State of the art of new vaccines: research and development (2005), World Health Organization, Geneva. http://www.who.int/.vaccine_research/documents/stateoftheart/en/index.html (accessed Jan 26, 2010).
6. Wang R., Doolan D.L., Le T.P., et al. Induction of antigen-specific cytotoxic T lymphocytes in humans by a malaria DNA vaccine. Science 282 (1998) 476-480
7. Genton B., Betuela I., Felger I., et al. A recombinant blood-stage malaria vaccine reduces Plasmodium falciparum density and exerts selective pressure on parasite populations in a phase 1-2b trial in Papua New Guinea. J Infect Dis 185 (2002) 820-827
8. Kumar S., Epstein J.E., Richie T.L., et al. A multilateral effort to develop DNA vaccines against falciparum malaria. Trends Parasitol 18 (2002) 129-135
9. Moorthy V.S., Imoukhuede E.B., Milligan P., et al. A randomised, double-blind, controlled vaccine efficacy trial of DNA/MVA ME-TRAP against malaria infection in Gambian adults. PLoS Med 1 (2004) e33
10. Walther M., Dunachie S., Keating S., et al. Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720. Vaccine 23 (2005) 857-864
11. Dunachie S.J., Walther M., Epstein J.E., et al. A DNA prime-modified vaccinia virus ankara boost vaccine encoding thrombospondin-related adhesion protein but not circumsporozoite protein partially protects healthy malaria-naive adults against Plasmodium falciparum sporozoite challenge. Infect Immun 74 (2006) 5933-5942
12. Bejon P., Mwacharo J., Kai O., et al. A phase 2b randomised trial of the candidate malaria vaccines FP9 ME-TRAP and MVA ME-TRAP among children in Kenya. PLoS Clin Trials 1 (2006) e29
13. Dunachie S.J., Walther M., Vuola J.M., et al. A clinical trial of prime-boost immunisation with the candidate malaria vaccines RTS,S/AS02A and MVA-CS. Vaccine 24 (2006) 2850-2859
14. Stoute J.A., Gombe J., Withers M.R., et al. Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya. Vaccine 25 (2007) 176-184
15. Mullen G.E., Giersing B.K., Ajose-Popoola O., et al. Enhancement of functional antibody responses to AMA1-C1/Alhydrogel, a Plasmodium falciparum malaria vaccine, with CpG oligodeoxynucleotide. Vaccine 24 (2006) 2497-2505
16. Ballou W.R. The development of the RTS,S malaria vaccine candidate: challenges and lessons. Parasite Immunol 31 (2009) 492-500
17. Thera M. A randomized, controlled, Phase 2b clinical trial to evaluate the safety, immunogenicity and efficacy of WRAIR's AMA-1 malaria vaccine (FMP2.1) adjuvanted with GSK Biologicals' AS02A vs rabies vaccine in 1-6 year old children in Bandiagara, Mali. 5th MIM Pan-African Malaria Conference; Nairobi, Kenya; Nov 5, 2009.
18. Hill A. Towards more effective malaria vaccines. Parasite biology and host-parasite interactions; Magdalen College, Oxford, UK; Sept 6-11, 2009.
19. WHO. Initiative for Vaccine Research: malaria vaccines. http://www.who.int/vaccine_research/links/Rainbow/en/index.html (accessed Jan 26, 2010).
20. McConkey S.J., Reece W.H., Moorthy V.S., et al. Enhanced T-cell immunogenicity of plasmid DNA vaccines boosted by recombinant modified vaccinia virus Ankara in humans. Nat Med 9 (2003) 729-735
21. Kester K.E., Cummings J.F., 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 (2009) 337-346
22. Gilbert S.C., Moorthy V.S., Andrews L., et al. Synergistic DNA-MVA prime-boost vaccination regimes for malaria and tuberculosis. Vaccine 24 (2006) 4554-4561
23. Stoute J.A., Slaoui M., Heppner D.G., et al. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N Engl J Med 336 (1997) 86-91
24. Lalvani A., Moris P., Voss G., et al. Potent induction of focused Th1-type cellular and humoral immune responses by RTS,S/SBAS2, a recombinant Plasmodium falciparum malaria vaccine. J Infect Dis 180 (1999) 1656-1664
25. Garcon N., Heppner D.G., and Cohen J. Development of RTS,S/AS02: a purified subunit-based malaria vaccine candidate formulated with a novel adjuvant. Expert Rev Vaccines 2 (2003) 231-238
26. Pombo D.J., Lawrence G., Hirunpetcharat C., et al. Immunity to malaria after administration of ultra-low doses of red cells infected with Plasmodium falciparum. Lancet 360 (2002) 610-617
27. Edstein M.D., Kotecka B.M., Anderson K.L., et al. Lengthy antimalarial activity of atovaquone in human plasma following atovaquone-proguanil administration. Antimicrob Agents Chemother 49 (2005) 4421-4422
28. Roestenberg M., McCall M., Hopman J., et al. Protection against a malaria challenge by sporozoite inoculation. N Engl J Med 361 (2009) 468-477
29. Takala S.L., Coulibaly D., Thera M.A., et al. Dynamics of polymorphism in a malaria vaccine antigen at a vaccine-testing site in Mali. PLoS Med 4 (2007) e93
30. Duan J., Mu J., Thera M.A., et al. Population structure of the genes encoding the polymorphic Plasmodium falciparum apical membrane antigen 1: implications for vaccine design. Proc Natl Acad Sci USA 105 (2008) 7857-7862
31. Moorthy V.S., Reed Z., and Smith P.G. MALVAC 2008: measures of efficacy of malaria vaccines in phase 2b and phase 3 trials-scientific, regulatory and public health perspectives. Vaccine 27 (2009) 624-628
32. Doolan D.L., and Hoffman S.L. The complexity of protective immunity against liver-stage malaria. J Immunol 165 (2000) 1453-1462
33. Herrera S., Perlaza B.L., Bonelo A., and Arevalo-Herrera M. Aotus monkeys: their great value for anti-malaria vaccines and drug testing. Int J Parasitol 32 (2002) 1625-1635
34. Lyon J.A., Angov E., Fay M.P., et al. Protection induced by Plasmodium falciparum MSP1(42) is strain-specific, antigen and adjuvant dependent, and correlates with antibody responses. PLoS One 3 (2008) e2830
35. Praba-Egge A.D., Montenegro S., Cogswell F.B., Hopper T., and James M.A. Cytokine responses during acute simian Plasmodium cynomolgi and Plasmodium knowlesi infections. Am J Trop Med Hyg 67 (2002) 586-596
36. Badell E., Oeuvray C., Moreno A., et al. Human malaria in immunocompromised mice: an in vivo model to study defense mechanisms against Plasmodium falciparum. J Exp Med 192 (2000) 1653-1660
37. van der Kolk M., De Vlas S.J., Saul A., van de Vegte-Bolmer M., Eling W.M., and Sauerwein R.W. Evaluation of the standard membrane feeding assay (SMFA) for the determination of malaria transmission-reducing activity using empirical data. Parasitology 130 (2005) 13-22
38. Langermans J.A., Hensmann M., van Gijlswiik M., et al. Preclinical evaluation of a chimeric malaria vaccine candidate in Montanide ISA 720: immunogenicity and safety in rhesus macaques. Hum Vaccin 2 (2006) 222-226
39. Malkin E., Hu J., Li Z., et al. A phase 1 trial of PfCP2.9: an AMA1/MSP1 chimeric recombinant protein vaccine for Plasmodium falciparum malaria. Vaccine 26 (2008) 6864-6873
40. Bouharoun-Tayoun H., Attanath P., Sabchareon A., Chongsuphajaisiddhi T., and Druilhe P. Antibodies that protect humans against Plasmodium falciparum blood stages do not on their own inhibit parasite growth and invasion in vitro, but act in cooperation with monocytes. J Exp Med 172 (1990) 1633-1641
41. Galamo C.D., Jafarshad A., Blanc C., and Druilhe P. Anti-MSP1 block 2 antibodies are effective at parasite killing in an allele-specific manner by monocyte-mediated antibody-dependent cellular inhibition. J Infect Dis 199 (2009) 1151-1154
42. Reed Z.H., Kieny M.P., Engers H., et al. Comparison of immunogenicity of five MSP1-based malaria vaccine candidate antigens in rabbits. Vaccine 27 (2009) 1651-1660
43. Miura K., Zhou H., Moretz S.E., et al. Comparison of biological activity of human anti-apical membrane antigen-1 antibodies induced by natural infection and vaccination. J Immunol 181 (2008) 8776-8783
44. McIntosh R.S., Shi J., Jennings R.M., et al. The importance of human FcγRI in mediating protection to malaria. PLoS Pathog 3 (2007) e72
45. Plotkin S.A. Vaccines: correlates of vaccine-induced immunity. Clin Infect Dis 47 (2008) 401-409
46. Aponte J.J., 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. Lancet 370 (2007) 1543-1551
47. Alonso P.L., Sacarlal J., Aponte J.J., et al. Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet 364 (2004) 1411-1420
48. Bojang K.A., Milligan P.J., 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. Lancet 358 (2001) 1927-1934
49. Bejon P., Lusingu J., and Olutu A. Efficacy of the RTS,S/AS01E vaccine against clinical episodes of falciparum malaria in 5 to 17 month old children in Kenya and Tanzania. N Engl J Med 359 (2008) 2521-2532
50. Guinovart C., Aponte J.J., 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 One 4 (2009) e5165
51. Qin L., Gilbert P.B., Corey L., McElrath M.J., and Self S.G. A framework for assessing immunological correlates of protection in vaccine trials. J Infect Dis 196 (2007) 1304-1312
52. Hill A.V. Pre-erythrocytic malaria vaccines: towards greater efficacy. Nat Rev Immunol 6 (2006) 21-32
53. Kester K.E., McKinney D.A., Tornieporth N., et al. Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J Infect Dis 183 (2001) 640-647
54. Verhage D.F., Telgt D.S., Bousema J.T., et al. Clinical outcome of experimental human malaria induced by Plasmodium falciparum-infected mosquitoes. Neth J Med 63 (2005) 52-58
55. Heppner Jr. D.G., Kester K.E., Ockenhouse C.F., et al. Towards an RTS,S-based, multi-stage, multi-antigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of Research. Vaccine 23 (2005) 2243-2250
56. Moorthy V.S., Diggs C., Ferro S., et al. Report of a consultation on the optimization of clinical challenge trials for evaluation of candidate blood stage malaria vaccines, 18-19 March 2009, Bethesda, MD, USA. Vaccine 27 (2009) 5719-5725
57. Sanderson F., Andrews L., Douglas A.D., Hunt-Cooke A., Bejon P., and Hill A.V. Blood-stage challenge for malaria vaccine efficacy trials: a pilot study with discussion of safety and potential value. Am J Trop Med Hyg 78 (2008) 878-883
58. Bejon P., Andrews L., Andersen R.F., et al. Calculation of liver-to-blood inocula, parasite growth rates, and preerythrocytic vaccine efficacy, from serial quantitative polymerase chain reaction studies of volunteers challenged with malaria sporozoites. J Infect Dis 191 (2005) 619-626
59. Mwangi T.W., Ross A., Snow R.W., and Marsh K. Case definitions of clinical malaria under different transmission conditions in Kilifi District, Kenya. J Infect Dis 191 (2005) 1932-1939
60. PATH Malaria Vaccine Initiative. Evaluation technologies: the field needs new evaluation tools. http://www.malariavaccine.org/rd-eval-tech.php (accessed Jan 26, 2010).
61. European Malaria Vaccine Development Association. An EC funding mechanism for malaria vaccines focusing on comparative evaluation. http://www.emvda.org/ (accessed Feb 5, 2010).
62. PATH Malaria Vaccine Initiative. Immunoassays: working to enhance vaccine evaluation tools. http://www.malariavaccine.org/rd-immunoassays.php (accessed Jan 26, 2010).