Phase 1 Study in Malaria Naïve Adults of BSAM2/Alhydrogel®+CPG 7909, a Blood Stage Vaccine against P. falciparum Malaria

PLoS ONE

Volumn 7, Issue 10, 2012, Pages

  Ellis, Ruth D ^a,c   Wu, Yimin ^a   Martin, Laura B ^a,d   Shaffer, Donna ^b   Miura, Kazutoyo ^a   Aebig, Joan ^a   Orcutt, Andrew ^a   Rausch, Kelly ^a   Zhu, Daming ^a   Mogensen, Anders ^a,e   Fay, Michael P ^a   Narum, David L ^a   Long, Carole ^a   Miller, Louis ^a   Durbin, Anna P ^b  

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

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c Aeras Global TB Vaccine Foundation   (United States)

^d NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

^e LEO PHARMA A S   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ADJUVANT; AGATOLIMOD; ALUMINUM HYDROXIDE; APICAL MEMBRANE ANTIGEN 1; BLOOD STAGE ANTIGEN MIXTURE 2 ALHYDROGEL PLUS AGATOLIMOD; MALARIA VACCINE; MEROZOITE SURFACE PROTEIN 1; PROTOZOAL PROTEIN; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG;

ADULT; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; DRUG MEGADOSE; DRUG SAFETY; FEVER; GROWTH INHIBITION; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; IN VITRO STUDY; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; LOW DRUG DOSE; MALAISE; MALARIA FALCIPARUM; MYALGIA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; REPEATED DRUG DOSE; SYSTEMIC DISEASE; UNSPECIFIED SIDE EFFECT; VACCINATION;

ADOLESCENT; ADULT; ALUMINUM HYDROXIDE; ANTIBODIES, PROTOZOAN; ANTIGENS, PROTOZOAN; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; ERYTHROCYTES; FEMALE; FOLLOW-UP STUDIES; HEADACHE; HUMANS; MALARIA VACCINES; MALARIA, FALCIPARUM; MALE; MEMBRANE PROTEINS; MEROZOITE SURFACE PROTEIN 1; MIDDLE AGED; OLIGODEOXYRIBONUCLEOTIDES; PLASMODIUM FALCIPARUM; PROTOZOAN PROTEINS; RECOMBINANT FUSION PROTEINS; TREATMENT OUTCOME; VACCINATION; YOUNG ADULT;

PLASMODIUM FALCIPARUM;

EID: 84867134168     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0046094     Document Type: Article

References (35)

1. WHO (2011) World Malaria Report 2011. http://www.who.int/malaria/world_malaria_report_2011/en/Ref Type: Internet Communication.
2. Murray CJL, Rosenfeld LC, Lim SS, Andrews KG, Foreman KJ, et al. (2012) Global malaria mortality between 1980 and 2010: a systematic analysis. Lancet 379 (9814) (): 413-31.
3. Agnandji ST, Lell B, Soulanoudjingar SS, Fernandes JF, Abossolo BP, et al. (2011) First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med 365 (20) (): 1863-75.
4. Cohen S, McGregor IA, Carrington, (1961) Gamma-globulin and acquired immunity to human malaria. Nature 192: 733-7.
5. Singh S, Miura K, Zhou H, Muratova O, Keegan B, et al. (2006) Immunity to recombinant plasmodium falciparum merozoite surface protein 1 (MSP1): protection in Aotus nancymai monkeys strongly correlates with anti-MSP1 antibody titer and in vitro parasite-inhibitory activity. Infect Immun 74 (8) (): 4573-80.
6. Stowers AW, Kennedy MC, Keegan BP, Saul A, Long CA, et al. (2002) Vaccination of monkeys with recombinant Plasmodium falciparum apical membrane antigen 1 confers protection against blood-stage malaria. Infect Immun 70 (12) (): 6961-7.
7. Ellis RD, Sagara I, Doumbo O, Wu Y, (2010) Blood stage vaccines for Plasmodium falciparum: Current status and the way forward. Human Vaccines 6 (8) (): 627-34.
8. Goodman AL, Draper SJ, (2010) Blood-stage malaria vaccines- recent progress and future challenges. Ann Trop Med Parasitol 104 (3) (): 189-211.
9. Thera MA, Doumbo OK, Coulibaly D, Laurens MB, Ouattara A, et al. (2011) A field trial to assess a blood-stage malaria vaccine. N Engl J Med 365 (11) (): 1004-13.
10. Narum DL, Ogun SA, Batchelor AH, Holder AA, (2006) Passive immunization with a multicomponent vaccine against conserved domains of apical membrane antigen 1 and 235-kilodalton rhoptry proteins protects mice against Plasmodium yoelii blood-stage challenge infection. Infect Immun 74 (10) (): 5529-36.
11. Mullen GE, Ellis RD, Miura K, Malkin E, Nolan C, et al. (2008) Phase 1 Trial of AMA1-C1/Alhydrogel plus CPG 7909: An Asexual Blood-Stage Vaccine for Plasmodium falciparum Malaria. PLoS One 3 (8) (): e2940.
12. Ellis RD, Martin LB, Shaffer D, Long CA, Miura K, et al. (2010) Phase 1 Trial of the Plasmodium falciparum blood stage vaccine MSP142-C1/Alhydrogel with and without CPG 7909 in Malaria Naïve Adults. PLoS One 5 (1) (): e8787.
13. Sagara I, Ellis RD, Dicko A, Niambele MB, Kamate B, et al. (2009) A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel+CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults. Vaccine 27 (52) (): 7292-8.
14. 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 (6) (): 3677-85.
15. Giersing B, Miura K, Shimp R, Wang J, Zhou H, et al. (2005) Posttranslational Modification of Recombinant Plasmodium falciparum Apical Membrane Antigen 1: Impact on Functional Immune Responses to a Malaria Vaccine Candidate. Infect Immun 73 (7) (): 3963-70.
16. Malkin E, Long CA, Stowers AW, Zou L, Singh S, et al. (2007) Phase 1 Study of Two Merozoite Surface Protein 1 (MSP1(42)) Vaccines for Plasmodium falciparum Malaria. PLoS Clin Trials 2 (4) (): e12.
17. Ellis RD, Mullen GE, Pierce M, Martin LB, Miura K, et al. (2009) A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel with CPG 7909, using two different formulations and dosing intervals. Vaccine 24;27 (31) (): 4104-9.
18. Miura K, Orcutt AC, Muratova OV, Miller LH, Saul A, et al. (2008) Development and characterization of a standardized ELISA including a reference serum on each plate to detect antibodies induced by experimental malaria vaccines. Vaccine 26 (2) (): 193-200.
19. Miura K, Zhou H, Diouf A, Moretz SE, Fay MP, et al. (2009) Anti-apical-membrane-antigen-1 antibody is more effective than anti-42-kilodalton-merozoite-surface-protein-1 antibody in inhibiting plasmodium falciparum growth, as determined by the in vitro growth inhibition assay. Clin Vaccine Immunol 16 (7) (): 963-8 Epub 2009 May 13.
20. Fay MP, (2005) Random marginal agreement coefficients: rethinking the adjustment for chance when measuring agreement. Biostatistics 6: 171-80.
21. Krieg AM, Efler SM, Witpoth M, Al Adhami MJ, Davis HL, (2004) Induction of systemic Th1-like innate immunity in normal volunteers following subcutaneous but not intravenous admiration of CPG 7909, a synthetic B-class CpG oligodeoxynucleotide TLR9 agonist. J Immunotherapy 27 (6) (): 460-71.
22. Saul A, Lawrence G, Smillie A, Rzepczyk CM, Reed C, et al. (1999) Human phase I vaccine trials of 3 recombinant asexual stage malaria antigens with Montanide ISA720 adjuvant. Vaccine 17 (23-24) (): 3145-59.
23. Genton B, Al-Yaman F, Anders R, Saul A, Brown G, et al. (2000) Safety and immunogenicity of a three-component blood-stage malaria vaccine in adults living in an endemic area of Papua New Guinea. Vaccine 18 (23) (): 2504-11.
24. Genton B, Al-Yaman F, Betuela I, Anders RF, Saul A, et al. (2003) Safety and immunogenicity of a three-component blood-stage malaria vaccine (MSP1, MSP2, RESA) against Plasmodium falciparum in Papua New Guinean children. Vaccine 22 (1) (): 30-41.
25. Miura K, Zhou H, Diouf A, Moretz SE, Fay MP, et al. (2009) Anti-apical-membrane-antigen-1 antibody is more effective than anti-42-kilodalton-merozoite-surface-protein-1 antibody in inhibiting plasmodium falciparum growth, as determined by the in vitro growth inhibition assay. Clin Vaccine Immunol 16 (7) (): 963-8.
26. Duncan CJ, Sheehy SH, Ewer KJ, Douglas AD, Collins KA, et al. (2011) Impact on malaria parasite multiplication rates in infected volunteers of the protein-in-adjuvant vaccine AMA1-C1/Alhydrogel+CPG 7909. PLoS One 6 (7) (): e22271.
27. Duncan CJA, Hill AVS, Ellis RD, (2012) Can growth inhibition assays (GIA) predict blood-stage malaria vaccine efficacy? Human Vaccines and Immunotherapeutics 8 (6) () Epub ahead of print.
28. Takala SL, Coulibaly D, Thera MA, Batchelor AH, Cummings MP, et al. (2009) Extreme polymorphism in a vaccine antigen and risk of clinical malaria: implications for vaccine development. Sci Transl Med 1 (2) (): 2ra5.
29. Duan J, Mu J, Thera MA, Joy D, Kosakovsky Pond SL, et al. (2008) Population structure of the genes encoding the polymorphic Plasmodium falciparum apical membrane antigen 1: implications for vaccine design. Proc Natl Acad Sci U S A 105 (22) (): 7857-62.
30. Ogutu BR, Apollo OJ, McKinney D, Okoth W, Siangla J, et al. (2009) Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya. PLoS One 4 (3) (): e4708.
31. Sagara I, Dicko A, Ellis RD, Fay MP, Diawara SI, et al. (2009) A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali. Vaccine 27 (23) (): 3090-8.
32. Ouattara A, Mu J, Takala-Harrison S, Saye R, Sagara I, et al. (2010) Lack of allele-specific efficacy of a bivalent AMA1 malaria vaccine. Malar J 9: 175.
33. Lyon JA, Angov E, Fay MP, Sullivan JS, Girourd AS, et al. (2008) Protection induced by Plasmodium falciparum MSP1(42) is strain-specific, antigen and adjuvant dependent, and correlates with antibody responses. PLoS One 3 (7) (): e2830.
34. Dutta S, Sullivan JS, Grady KK, Haynes JD, Komisar J, et al. (2009) High antibody titer against apical membrane antigen-1 is required to protect against malaria in the Aotus model. PLoS One 4 (12) (): e8138.
35. Pombo DJ, Lawrence G, Hirunpetcharat C, Rzepczyk C, Bryden M, et al. (2002) Immunity to malaria after administration of ultra-low doses of red cells infected with Plasmodium falciparum. Lancet 360 (9333) (): 610-7.