Phase 1/2a study of the malaria vaccine candidate apical membrane antigen-1 (AMA-l) administered in adjuvant system AS01B or AS02A

PLoS ONE

Volumn 4, Issue 4, 2009, Pages

  Spring, Michele D ^a   Cummings, James F ^a   Ockenhouse, Christian F ^a   Dutta, Sheetij ^a   Reidler, Randall ^a   Angov, Evelina ^a   Bergmann Leitner, Elke ^a   Stewart, V Ann ^a   Bittner, Stacey ^a   Juompan, Laure ^a,i   Kortepeter, Mark G ^a   Nielsen, Robin ^a   Krzych, Urszula ^a   Tierney, Ev ^b   Ware, Lisa A ^a   Dowler, Megan ^a   Hermsen, Cornelus C ^c   Sauerwein, Robert W ^c   de Vlas, Sake J ^d   Ofori Anyinam, Opokua ^e   Lanar, David E ^a   Williams, Jack L ^a   Kester, Kent E ^a   Tucker, Kathryn ^f   Shi, Meng ^a   Malkin, Elissa ^b   Long, Carole ^g   Diggs, Carter L ^h   Soisson, Lorraine ^h   Duboiss, Marie Claude ^e   Ballou, W Ripley ^e,j   Cohen, Joe ^e   Heppner Jr , D Gray ^a   more..

^a WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

^b Program for Appropriate Technology in Health PATH Malaria Vaccine Initiative   (United States)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^d ERASMUS MEDICAL CENTER   (Netherlands)

^e GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^f University of Iowa   (United States)

^g NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^h UNITED STATES AGENCY FOR INTERNATIONAL DEVELOPMENT   (United States)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j BILL AND MELINDA GATES FOUNDATION   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

APICAL MEMBRANE ANTIGEN 1; CHLOROQUINE; GAMMA INTERFERON; IMMUNOLOGICAL ADJUVANT; LIPOSOME; MALARIA VACCINE; PARASITE ANTIBODY; APICAL MEMBRANE ANTIGEN I, PLASMODIUM; ASO2A ADJUVANT; DRUG DERIVATIVE; LIPID A; MEMBRANE PROTEIN; PARASITE ANTIGEN; PROTOZOAL PROTEIN; SAPONIN;

ADULT; ANTIBODY DETECTION; ANTIBODY RESPONSE; ARTHRALGIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; FATIGUE; FEMALE; HUMAN; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE SWELLING; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALAISE; MALARIA FALCIPARUM; MALE; MYALGIA; NAUSEA; PAPULE; PARASITEMIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PLASMODIUM FALCIPARUM; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SKIN INFLAMMATION; SPOROZOITE; ADOLESCENT; ALLELE; ANIMAL; DRUG COMBINATION; ENZYME LINKED IMMUNOSORBENT ASSAY; GENETICS; IMMUNOLOGY; METABOLISM; MIDDLE AGED;

PLASMODIUM FALCIPARUM;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ALLELES; ANIMALS; ANTIGENS, PROTOZOAN; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; LIPID A; MALARIA VACCINES; MALARIA, FALCIPARUM; MEMBRANE PROTEINS; MIDDLE AGED; PLASMODIUM FALCIPARUM; PROTOZOAN PROTEINS; SAPONINS;

EID: 65449181983     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0005254     Document Type: Article

References (45)

1. World Health Organization and UNICEF (2005) World Malaria Report 2005. Report no. WHO/HTM/MAL/2005.1102. Geneva: World Health Organization. pp 271-72.
2. Duffy PE, Fried M (2005) Malaria in the pregnant woman. Curr Top Microbiol Immun 295: 169-200.
3. Moorthy VS, Good MF, Hill AVS (2004) Malaria Vaccine Developments. Lancet 363: 150-156.
4. Healer J, Crawford S, Ralph S, McFadden G, Cowman A (2002) Independent translocation of two micronemal proteins in developing Plasmodium falciparum merozoites. Infect Immun 70: 5751-5758.
5. Howell SA, Withers-Martinez C, Kocken CHM, Thomas AW, Blackman MJ (2001) Proteolytic processing and primary structure of Plasmodium falciparum apical membrane antigen-1. J Biol Chem 276: 31311-31320.
6. Mitchell GH, Thomas AW, Margos G, Dluzewski AR, Banister LH (2004) Apical membrane antigen 1, a major malaria vaccine candidate, mediates close attachment to invasive merozoites to host red blood cells. Infect Immun 72: 154-158.
7. Silvie O, Franetich JF, Charrin S, Mueller MS, Siau M, et al. (2004) A role for apical membrane antigen 1 during invasion of hepatocytes by Plasmodium falciparum sporozoites. J Biol Chem 279: 9490-9496.
8. Hodder AN, Crewther PE, Anders RF (2001) Specificity of the protective antibody response to apical membrane antigen 1. Infect Immun 69: 3286-3294.
9. Polley SD, Mwangi T, Kocken CHM, Thomas AW, Dutta S, et al. (2004) Human antibodies to recombinant protein constructs of Plasmodium falciparum apical membrane antigen 1 (AMA1) and their associations with protection from malaria. Vaccine 23: 718-728.
10. Udhayakumar V, Kariuki S, Kolczack M, Girma M, Roberts JM, et al. (2001) Longitudinal study of natural immune responses to the Plasmodium falciparum membrane antigen (AMA-1) in a holoendemic region of malaria in Western Kenya: Asembo Bay Cohort Project VIII. Am J Trop Med Hyg 65: 100-107.
11. Lal AA, Hughes MA, Oliveira DA, Nelson C, Bloland PB, et al. (1996) Identification of T-cell determinants in natural immune responses to the Plasmodium falciparum apical membrane antigen 1 (AMA-1) in an adult population exposed to malaria. Infect Immun 64: 1054-1059.
12. Anders RF, Crewther PE, Edwars S, Margetts M, Matthew MLSM, et al. (1998) Immunisation with recombinant AMA-1 protects mice against infection with Plasmodium chabaudi. Vaccine 16: 240-247.
13. Deans JA, Knight AM, Jean WC, Waters AP, Cohen S, et al. (1988) Vaccination trials in rhesus monkeys with a minor, invariant, Plasmodium knowlesi 66 kD merozoite antigen. Parasit Immunol 10: 535-552.
14. Stowers AW, Kennedy MC, Keegan BP, Saul A, Long CA, Miller LH (2002) Vaccination of monkeys with recombinant Plasmodium falciparum apical membrane antigen 1 confers protection against blood-stage malaria. Infect Immun 70: 6961-6967.
15. Krzych U, Lyon JA, Jareed T, Schneider I, Hollingdale MR, et al. (1995) T lymphocytes from volunteers immunized with irradiated Plasmodium falciparum sporozoites recognize liver and blood stage antigens. J Immunol 155: 4072-4077.
16. Polhemus M, Magill AJ, Cummings JF, Kester KE, Ockenhouse CF, et al. (2007) Phase I dose escalation safety and immunogenicity trial of Plasmodium falciparum apical membrane protein (AMA-1) FMP2.1, adjuvanted with AS02A, in malaria-naïve adults at the Walter Reed Army Institute of Research. Vaccine 25: 4203-4212.
17. Thera MA, Doumbo OK, Coulibaly D, Diallo DA, Kone AK, et al. (2008) Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a Phase 1 randomized trial. PLoS ONE 3: 1465.
18. Mettens P, Dubois PM, Demoitie MA, Bayat B, Donner MN, et al. (2008) Improved T cell responses to Plasmodium falciparum circumsporozoite protein in mice and monkeys induced by a novel formulation of RTS,S vaccine antigen. Vaccine 26: 1072-1082.
19. Pichyangkul S, Gettayacamin M, Miller RS, Lyon JA, Angov E, et al. (2004) Pre-clinical evaluation of the malaria vaccine candidate P. falciparum MSP1(42) formulated with novel adjuvants or with alum. Vaccine 22: 3831-40.
20. Stewart VA, McGrath SM, Walsh DS, Davis S, Hess AS, et al. (2006) Pre-clinical evaluation of new adjuvant formulations to improve the immunogenicity of the malaria vaccine RTS,S/AS02A. Vaccine 24: 6483-6492.
21. Chulay JD, Schneider I, Cosgriff TM, Hoffman SL, Ballou WR, et al. (1986) Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum. Am J Trop Med 35: 66-68.
22. Heppner DG, Kester KE, Ockenhouse CF, Tornieporth N, et al. (2005) Towards an RTS,S-based, multi-stage, multi-antigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of Research. Vaccine 23: 2243-50.
23. Dutta S, Lalitha PV, Ware LA, Barbosa A, Moch JK, Vassell MA, et al. (2001) Purification, characterization, and immunogenicity of the refolded ectodomain of the Plasmodium falciparum apical membrane antigen 1 expressed in Escherichia coli. Infect Immun 70: 3101-3110.
24. Garçon N, Chomez P, Van Mechelen M (2007) GlaxoSmithKline Adjuvant Systems in vaccines: concepts, achievements, and perspectives. Expert Rev Vaccines 6: 723-739.
25. 42. Am J Trop Med Hyg 72: 714-8.
26. Bergmann-Leitner ES, Duncan EH, Mullen GE, Burge JR, et al. (2006) Critical evaluation of different methods for measuring the functional activity of antibodies against malaria blood stage antigens. Am J Trop Med Hyg 75: 437-442.
27. Malkin EM, Diemert DJ, McArthur JH, Perreault JR, Miles AP, et al. (2005) Phase 1 clinical trial of apical membrane antigen 1: an asexual blood-stage vaccine for Plasmodium falciparum malaria. Infect Immun 73: 3677-3685.
28. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, et al. (2001) Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J Infect Dis 183: 640-7.
29. Andrews L, Andersen RF, Webster D, Dunachie S, Walther R, et al. (2005) Quantitative real-time polymerase chain reaction for malaria diagnosis and its use in malaria vaccine clinical trials. Am J Trop Med Hyg 73: 191-98.
30. Hermsen CC, Telgt DSC, Linders E, van de Locht LATF, et al. (2001) Detection of Plasmodium falciparum malaria parasites in vivo by real-time quantitative PCR. Mol Biochem. Parasitol 118: 247-251.
31. Hermsen CC, de Vlas SJ, Van Gemert GJA, Telgt DSC, et al. (2004) Testing vaccines in human experimental malaria: statistical analysis of parasitemia measured by a quantitative real-time polymerase chain reaction. Am J Trop Med Hyg 71: 196-201.
32. Kester KE, Cummings JF, Ockenhouse CF, Nielsen R, et al. (2008) 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-naïve adults at the Walter Reed Army Institute of Research. Vaccine 26: 2191-2202.
33. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, et al. (2007) 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/AS02 in malaria-naïve adults. Vaccine 25: 5359-5366.
34. Roestenberg M, Remarque E, de Jonge E, Hermsen R, et al. (2008) Safety and immunogenicity of a recombinant Plasmodium falciparum AMA1 malaria vaccaine adjuvanted with Alhydrogel™, Montanide ISA 720 or AS02A. PLoSONE 3: e3960.
35. Meth MJ, Sperber KE (2006) Phenotypic diversity in delayed drug hypersensitivity: an immunologic explanation. Mt Sin Jour Med 73: 769-776.
36. Druilhe P, Spertini F, Soesoe D, Corradin G, Mejia P, Singh S, et al. (2005) A malaria vaccine that elicits in humans antibodies able to kill Plasmodium falciparum. PLoS Med e344.
37. Lawrence G, Cheng Q, Reed C, Taylor D, Stowers A, Cloonan N, et al. (2000) Effect of vaccination with 3 recombinant asexual-stage malaria antigens on initial growth rates of Plasmodium falciparum in non-immune volunteers. Vaccine 18: 1925-1931.
38. 42) vaccines for Plasmodium falciparum malaria. PLoS Clin Trials e12.
39. Ockenhouse CF, Angov E, Kester KE, Diggs C, Soisson L, et al. (2006) Phase 1 safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine. Vaccine 24: 3009-3017.
40. Sun P, Schwenk R, White K, Stoute JA, Cohen J, Ballou WR, et al. (2003) Protective immunity induced with malaria vaccine RTS,S, is linked to Plasmodium falciparum circumsporozoite protein-specific CD4+ and CD8+ T cells producing IFN-gamma. J Immunol 171: 6961-6967.
41. Keating SM, Bejon P, Bertoud T, Vuola JM, Todryk S, Webster DP, et al. (2005) Durable human memory T cells quantifiable by cultured enzyme-linked immunospot assays are induced by heterologous prime boost immunization and correlate with protection against malaria. J Immunol 75: 5675-5680.
42. Dunachie SJ, Walther M, Epstein JE, Keating S, Berthoud T, Andrews L, et al. (2006) A DNA prime-modified vaccinia virus Ankara boost vaccine encoding thrombospondin-related adhesion protein but not circumsporozoite protein partially protects healthy malaria-naïve adults against Plasmodium falciparum sporozoite challenge. Infect Immun 74: 5933-5942.
43. Dutta S, Lee SY, Batchelor AH, Lanar DE (2007) Structural basis of antigenic escape. Proc Natl Acad Sci USA 104: 12488-12493.
44. Takala SL, Coulibaly D, Thera MA, Dicko A, Smith DL, et al. (2007) Dynamics of polymorphism in a malaria vaccine antigen at a vaccine-testing site in Mali. PLoS Med 4: e93.
45. Genton B, Pluschke G, Degen L, Kammer AR, Westerfield N, et al. (2007) A randomized placebo-controlled phase Ia malaria vaccine trial of two virosome-formulated synthetic peptides in healthy adult volunteers. PLoS ONE 2: e1018.