Clinical development of malaria vaccines: Should earlier trials be done in malaria endemic countries?

Human Vaccines

Volumn 5, Issue 9, 2009, Pages 627-636

  Chilengi, Roma ^a  

^a KEMRI WELLCOME TRUST RESEARCH PROGRAMME   (Kenya)

Author keywords

Africa; Challenge models; Clinical trials; Malaria; Vaccines

Indexed keywords

GAMMA INTERFERON; INTERLEUKIN 1; INTERLEUKIN 6; MALARIA VACCINE; TUMOR NECROSIS FACTOR ALPHA;

AFRICA; CLINICAL RESEARCH; CLINICAL TRIAL; DISEASE MODEL; DRUG TARGETING; ENDEMIC DISEASE; FINANCIAL MANAGEMENT; GOVERNMENT REGULATION; HUMAN; MALARIA; MALARIA FALCIPARUM; NOTE; PARASITE TRANSMISSION; PARASITEMIA; PLASMODIUM FALCIPARUM; RESEARCH ETHICS; SPOROZOITE; VACCINE FAILURE;

EID: 70349098502     PISSN: 15548600     EISSN: 15548619     Source Type: Journal    
DOI: 10.4161/hv.9141     Document Type: Note

References (62)

1. Baird JK. Host Age as a Determinant of Naturally Acquired Immunity to Plasmodium falciparum. Porosltology Today 1995; 3:105-11.
2. WHO meeting report. Measures of efficacy of malaria vaccines in phase 2b and phase 3 trials-Scientific, regulatory and public health perspectives. Vaccine 2008; 25:5115-23.
3. Langhorne J, Ndungu FM, Sponaas A, Marsh K. Immunity to malaria: more questions than answers. Nature Immunology 2008; 9:725-32.
4. Potocnjak P, Yoshida N, Nussezweig R. Protection from Plasmodium berghei infection by priming and boosting T cells to a single class I-restricted epitope with recombinant carriers suitable for human use. Eur J Immunol 1980; 28:4345-55.
5. Ballou WR, Arevalo-Herrera M, Carucci D, Richie TL, Corrdin G, Diggs C, et al. Update on the clinical development of candidate malaria vaccines. Am J Trop Med Hyg 2004; 71:239-47.
6. Ballou WR, Kester KE, Stoute JA, Heppner DG. Malaria vaccines: triumphs or tribulations? Parassitologia 1999; 41:403-8.
7. Daly T, Long CA. Humoral response to a carboxy-terminal region of the merozoite surface protein-1 plays a predominant role in controlling blood stage infection in rodent malaria. J immunol 1995; 155:236-43.
8. Druilhe P, Sabchaeon A, Bouharoun-Tayoun H, Oeuvray C, Perignon JL. In vivo veritas: lessons from immunoglobulin-transfer experiments in malaria patients. Ann Trop Med Parasitol 1997; 91:37-53.
9. Cohen S, McGregor A, Carrington S. Gamma globulin and acquired immunity to human malaria. Nature 1961; 192:733-7.
10. Lyon JA, Thomas AW, Hall T, Chulay JD. Specificities of antibodies that inhibit merozoite dispersal from malaria-infected erythrocytes. Mol Biochem Parasitol 1989; 36:77-85.
11. Saul A, Miller LH. A robust neutralization test for Plasmodium falciparum malaria. J Exp Med 2001; 193:51-4.
12. Cheng Q, Lawrence G, Reed C, Stowers A, Ranford-Cartwright L, Creasey A, et al. Measurement Plasmodium falciparum growth rate in vivo: a test of malariavaccines. Am J Trop Med Hyg 1997; 57:495-500.
13. Bouharoun-Tayoun H, Attanah P, Sabchareon A, Chongsuphajaisiddhi T, 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 1990; 172:1633-41.
14. Bouharoun-Tayoun H, Druilhe P. Plasmodium falciparum malaria: evidence for an isotype imbalance which may be responsible for delayed acquisition of protective immunity. Infect Immun 1992; 60:1473-81.
15. Theisen M, Soe S, Oeuvray C, Thomas A, Vuust J, Denielsen S, et al. The Glutamate-Rich Protein (GLURP) of Plasmodium falciparum is a target for antibody-dependent monocyte-mediated inhibition of parasite growth in vitro. Infect Immun 1998; 66:11-7.
16. World Health Organization. Candidate malaria vaccines in clinical development. [online], 〈http://www.who.int/vaccine-research/documents/en/ malaria-table.pdf)〉 2008.
17. Richie TL, Saul A. Progress and challenges for malaria vaccines. Nature 2002; 415:694-701.
18. Schofield L, Vivas L, Gerold P, Schwarts RT, Tachado S, Hackett F. Neutralizing monoclonal antibodies to glycosylphosphatidylinositol, the dominant TNFalpha-inducing toxin of Plasmodium falciparum: prospects for the immunotherapy of severe malaria. Ann Trop Med Parasitol 1993; 87:617-26.
19. Bolad A, Berzins K. Antigenic diversity of Plasmodium falciparum and antibody-mediated parasite neutralization. Scand J Immunol 2000; 52:233-9.
20. Carter R. Transmission blocking malaria vaccines. Vaccine 2001; 19:2309-14.
21. Carter R, Mendis KN, Miller LH, Molineaux L, Saul A. Malaria transmission-blocking vaccines - how can their development be supported? Nature Med 2000; 6:241-4.
22. Pataroyo ME, Amador R, Clavijo P. A synthetic vaccine protects humans against challenge with asexual blood stages of Plasmodium falciparum malaria. Nature 1988; 332:158-61.
23. Shi YP, Hasnain SE, Sacci JB, Holloway BP, Fujioka H, Kumar N, et al. Immunogenicity and in vitro protective efficacy of a recombinant multistage Plasmodium falciparum candidate vaccine. Proc Natl Acad Sci USA 1999; 96:1615-20.
24. Doolan DL, Hoffman SL. DNA-based vaccines against malaria: status and promise of the multistage malaria DNA vaccine operation. Int J Parasitol 2001; 31:753-62.
25. Hanke T, Scneider J, Gilbert SC. DNA multi-CTL epitope vaccines for HIV and Plasmodium falciparum: immunogenicity in mice. Vaccine 1998; 16:426-35.
26. Rogers WO, Baird JK, Kumar A, Tine A, Weiss W, Aguiar J, et al. Multistage Multiantigen Heterologous Prime Boost Vaccine for Plasmodium knowlesi Malaria Provides Partial Protection in Rhesus Macaques. Infect Immun 2001; 9:5565-72.
27. Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE, Desmons P, et al. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N Eng J Med 1997; 336:86-91.
28. Saul A, Lawrence G, Smillie A, Rzepcyk CM, Reed C, Taylor D, et al. Human phase I vaccine trials of 3 recombinant asexual stage malaria antigens with Montanide ISA 720 adjuvant. Vaccine 1999; 17:3145-59.
29. Kilama WL, Chilengi R, Charles LW. Towards an African driven malaria vaccine development programme: history and activities of the African Malaria Network Trust (AMANET). Am J Trop Med Hyg 2007; 77:282-8.
30. Miller HL, Good MF, Milon G. Malaria pathogenesis. Science 1994; 264:1878-83.
31. Moorthy V, Reed Z, Smith PG. Measurement of malaria vaccine efficacy in phase III trials: Report of a WHO consultation. Vaccine 2007; 25:5115-23.
32. Rogier C, Trape JF. Malaria attacks in children exposed to high transmission: who is protected? Trans R Soc Trop Med Hyg 1993; 87:245-6.
33. Stowers AW, Miller HL. Are trials in new world monkeys on the critical path for bloodstage malaria-vaccine development? Trends Parasitol 2001; 17:415-9.
34. Siddhartha M, Saul A, Miller HL. Progress in the development of recombinant and synthetic blood-stage malaria vaccines. J Ex Bio 2003; 206:3781-8.
35. McIntosh RS, Shi J, Jennings RM, Chappel JC, de Koning-Ward TF, Smith T, et al. The importance of human Fcgamma RI in mediating protection to malaria. PLoS Pathog 2007; 3:647-58.
36. Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, et al. Efficacy of RTS,S/AS01E Vaccine against Malaria in Children 5 to 17 Months of Age. N Engl J Med 2008; 359:2521-32.
37. Guinovart C, Alonso P. Methods for determining vaccine efficacy and effectiveness and the main barriers to developing a fully deployable malaria vaccine. Am J Trop Med Hyg 2007; 77:276-81.
38. Sanderson F, Andrews L, Douglas DA, Hunt-Cooke A, Bejon P, Hill AVS. Blood-stage challenge for malaria vaccine efficacy trials: A pilot study with discussion of safety and potential value. Am J Trop Med Hyg 2008; 78:878-83.
39. Chulay JD, Schneider I, Cosgriff TM. Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum. Am Soc Trop Med Hyg 1986; 35:66-8.
40. Holder AA, Patino JJG, Uthaipibull C, Syed SEH, Ling IT, Scott-Finnigan T, et al. Merozoite surface protein 1, immune evasion, and vaccines against asexual blood stage malaria. Parassitologia 1999; 41:409-14.
41. Bouharoun-Tayoun H, Druilhe P. Antibodies in falciparum malaria: what matters most, quantity or quality? Mem Inst Oswaldo Cruz, Rio de Janeiro 1992; 87:229-34.
42. Bouharoun-Tayoun H, Attanah P, Sabchareon A, Chongsuphajaisiddhi T, 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 1990; 172:1633-41.
43. Roussilhon C, Oeuvray C, Müller-Graf C, Tall A, Rogier C, Trape J, et al. Long-term clinical protection from falciparum malaria is strongly associated with IgG3 antibodies to merozoite surface protein 3. PLoS Med 2007; 4:1791-803.
44. Moran M, Guzman J, Ropars A, Jorgensen M, McDonald A, Potter S, et al. The malaria product pipeline: Planning for the future. George Institute Publication 2007.
45. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, Hall T, et al. Efficacy of recombinant circumsporozoite protein vaccine against experimental Plasmodium falciparum malaria. J Infect Dis 2001; 183:640-7.
46. Stoute JA, Kester KE, Krzych U. Long term efficacy and immune responses following immunization with the RTS,S malaria vaccine. J Infec Dis 1998; 178:1139-44.
47. Hoffman SL, Goh LM, Luke TC, Schneider I, Le TP, Doolan DL, et al. Protection of humans against malaria by immunization with radiation-attenuated Plasmodium falciparum sporozoites. J Infect Dis 2002; 185:1155-64.
48. Clyde DS. Immunity to falciparum and vivax malaria induced by irradiated sporozoites: a review of the University of Maryland studies 1971-75. WHO Bull 1990; 68:9-12.
49. Beier JC, Onyango FK, Koros J, Ramadhan M, Ogwang R, Wirtz RA, et al. Quantitation of malaria sporozoites transmitted in vitro during salivation by wild Afrotropical Anopheles. Med Vet Entomo 1991; 5:71-9.
50. Hermsen CC, Telgt DS, Linders EH, Van de Locht LA, Eling WM, Mensink EJ, et al. Detection of Plasmodium falciparum malaria parasites in vivo by real-time quantitative PCR. Mol Biochem Parasitol 2001; 118:247-51.
51. Webster D, Hill AV. Progress with new malaria vaccines. Bull World Health Org 2003; 81:902-9.
52. Hill AVS. Pre-erythrocytic malaria vaccines: towards greater efficacy. Nature Reviews 2006; 6:21-32.
53. Hoffman SL, Edelman R, Bryan JP. Safety, immunogenicity and efficacy of a malaria sporozoites vaccine administered with monophosphoryl lipid A, cell wall skeleton of mycobacteria, and squualane as adjuvant. Am J Trop Med Hyg 1994; 51:603-12.
54. Pombo D, Lawrence G, Hirunpetcharat C, Rzepczyk C, Bryden M, Cloonan N, et al. Immunity to malaria after administration of ultra-low doses of red cells infected with plasmodium falciparum. Lancet 2002; 360:610-7.
55. PATH Malaria Vaccine Initiative & Energetics Incorporated. Malaria Vaccine Technology Roadmap 2006. [online] 〈www.malariavaccineroadmap.net/ dfs/Malaria-Vaccine-TRM-Final.pdf.〉.
56. World Health Organization. Assessment of therapeutic efficacy of antimalarial drugs for uncomplicated malaria in areas with intense transmission. 1996 WHO/MAL/96.1077. World Health Organization, Geneva, Switzerland.
57. Bojang KA, Milligan PJM, Pinder M, Vigneron L, Alloueche A, Kester KE, et al. Efficacy of RTSS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semiimmune adult men in The Gambia: a randomized trial. Lancet 2001; 358:1927-34.
58. Alonso P, Saccalal J, Aponte J, Leach A, Macete E, Millman J, et al. Efficacy of the RTSS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomized controlled trial. Lancet 2004; 364:1411-20.
59. Druilhe P, Barnwell JW. Pre-erythrocytic stage malaria vaccines: time for a change in path. Current Opinion in Microbiology 2007; 10:371-8.
60. African Vaccine Regulatory Forum (AVEREF). 2006 [online] 〈http://www.who.int/immunization-standards/vaccine-regulation/ africa-network/en/index.html〉.
61. Lavery J, Grady C, Wahl E, Emanuel E. Ethical Issues in International Biomedical Research: A Case Book 2007; ISBN 978-0-19-517922-4.
62. World Medical Association Declaration of Helsinki: ethical principles from medical tresearch involving human subjects. Paragraph 17. Revision adopted by the 59th World Medical Assembly, Seoul 2008.