Ad35.CS.01 - RTS,S/AS01 heterologous prime boost vaccine efficacy against sporozoite challenge in healthy malaria-naïve adults

PLoS ONE

Volumn 10, Issue 7, 2015, Pages

  Ockenhouse, Christian F ^a   Regules, Jason ^a   Tosh, Donna ^a   Cowden, Jessica ^a   Kathcart, April ^a   Cummings, James ^a   Paolino, Kristopher ^a   Moon, James ^a   Komisar, Jack ^a   Kamau, Edwin ^a   Oliver, Thomas ^a   Chhoeu, Austin ^a   Murphy, Jitta ^a   Lyke, Kirsten ^b   Laurens, Matthew ^b   Birkett, Ashley ^c   Lee, Cynthia ^c   Weltzin, Rich ^c   Wille Reece, Ulrike ^c   Sedegah, Martha ^d   Hendriks, Jenny ^e   Versteege, Isabella ^e   Pau, Maria Grazia ^e   Sadoff, Jerold ^e   Vanloubbeeck, Yannick ^f   Lievens, Marc ^f   Heerwegh, Dirk ^f   Moris, Philippe ^f   Mendoza, Yolanda Guerra ^f   Jongert, Erik ^f   Cohen, Joe ^f   Voss, Gerald ^f   Ballou, W Ripley ^f   Vekemans, Johan ^f   more..

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

^b UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^c PATH MVI   (United States)

^d NAVAL MEDICAL RESEARCH CENTER   (United States)

^e CRUCELL HOLLAND BV   (Netherlands)

^f GSK   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; CIRCUMSPOROZOITE PROTEIN; IMMUNOGLOBULIN G; PROTEIN RTS,S; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; GAMMA INTERFERON; MALARIA VACCINE; PROTOZOON ANTIBODY;

ABSENCE OF SIDE EFFECTS; ADULT; ANTIBODY TITER; ARTICLE; CD4+ T LYMPHOCYTE; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EX VIVO STUDY; FEMALE; HUMAN; HUMAN EXPERIMENT; MALARIA; MALE; NORMAL HUMAN; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SPOROZOITE; ANTIBODY PRODUCTION; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; IMMUNOLOGICAL PROCEDURES; IMMUNOLOGY; PROCEDURES; SECONDARY IMMUNIZATION; VACCINATION;

ANTIBODIES, PROTOZOAN; ANTIBODY FORMATION; CD4-POSITIVE T-LYMPHOCYTES; DOUBLE-BLIND METHOD; HUMANS; IMMUNIZATION, SECONDARY; IMMUNOGLOBULIN G; IMMUNOLOGIC TESTS; INTERFERON-GAMMA; MALARIA; MALARIA VACCINES; SPOROZOITES; VACCINATION;

EID: 84940173032     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0131571     Document Type: Article

References (42)

1. Steketee RW, Campbell CC (2010) Impact of national malaria control scale-up programmes in Africa: magnitude and attribution of effects. Malar J 9: 299. doi: 10.1186/1475-2875-9-299 PMID: 20979634
2. WHO World Malaria Report 2011. Available: http://www.who.int/malaria/world-malaria-report-2011/en/index.html.
3. World Health Organization. World malaria report 2012. World Health Organization Available: http://www.who.int/malaria/publications/world-malaria-report-2012/wmr2012-full-report.pdf.
4. WHO/IVR. State of the art of vaccine research and development: Initiative for vaccine research World Health Organization Available: http://www.who.int/vaccine-research/documents/Dip%20814.pdf.
5. malERA Consultative Group on Vaccines (2005) A research agenda for malaria eradication: vaccines. PLoS Med 8: e1000398.
6. Garcon N, Heppner DG, Cohen J (2003) Development of RTS,S/AS02: a purified subunit-based malaria vaccine candidate formulated with a novel adjuvant. Expert Rev Vaccines 2: 231-8. PMID: 12899574
7. Stewart VA, McGrath SM, Walsh DS, Davis S, Hess AS, Ware L, et al. (2006) Pre-clinical evaluation of new adjuvant formulations to improve the immunogenicity of the malaria vaccine RTS,S/AS02A. Vaccine 24: 6483-92. PMID: 16904798
8. Heppner DG Jr., Kester KE, Ockenhouse CF, Tornieporth N, Ofori-Anyinam O, Ofori O, 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. PMID: 15755604
9. Regules JA, Cummings JF, Ockenhouse C (2011) The RTS,S vaccine candidate for malaria. Expert Rev Vaccines 10: 589-99. doi: 10.1586/erv.11.57 PMID: 21604980
10. Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE, Desmons P, et al. (1997) A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N Engl J Med 336: 86-91. PMID: 8988885
11. Stoute JA, Kester KE, Krzych U, Wellde BT, Hall T, White K, et al. (1998) Long-term efficacy and immune responses following immunization with the RTS,S malaria vaccine. J Infect Dis 178: 1139-44. PMID: 9806046
12. Kester KE. McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, Hall T, et al. (2001) Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J Infect Dis 183: 640-7. PMID: 11170991
13. Kester KE, Cummings JF, Ofori-Anyinam O, Ockenhouse CF, Krzych U, Moris P, et al. (2009) Randomized, double-blind, phase 2a trial of falciparum malaria vaccines RTS,S/AS01 and RTS,S/AS02A in malaria-naive adults: safety, efficacy, and immunologic associates of protection. J Infect Dis 200: 337-46. doi: 10.1086/600120 PMID: 19569965
14. Bejon P, Andrews L, Andersen RF, Dunachie S, Webster D, Walther M, et al. (2005) 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: 619-26. PMID: 15655787
15. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Milman J, et al. (2004) Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomized controlled trial. Lancet 364: 1411-20. PMID: 15488216
16. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Aide P, et al. (2005) 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 randomized controlled trial. Lancet 366: 2012-8. PMID: 16338450
17. Aponte JJ, Aide P, Renom M, Mandomando I, Bassat Q, Guinovart C, et al. (2007) Safety of the RTS,S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomized controlled phase I/IIb trial. Lancet 370: 1543-51. PMID: 17949807
18. Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, et al. (2008) Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. N Engl J Med 359: 2521-32. doi: 10.1056/NEJMoa0807381 PMID: 19064627
19. Sacarlal J, Aide P, Aponte JJ, Renom M, Leach A, Mandomando I, et al. (2009) Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. J Infect Dis 200: 329-36. doi: 10.1086/600119 PMID: 19569964
20. Olotu A, Lusingu J, Leach A, Lievens M, Vekemans J, Msham S, et al. (2011) 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: 102-9. doi: 10.1016/S1473-3099(10)70262-0 PMID: 21237715
21. Asante KP, Abdulla S, Agnandji S, Lyimo J, Vekemans J, Soulanoudjingar S, et al. (2011) Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial. Lancet Infect Dis 11: 741-9. doi: 10.1016/S1473-3099(11)70100-1 PMID: 21782519
22. The RTS,S Clinical Trials Partnership (2011) First results of a phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med 365: 1863-75. doi: 10.1056/NEJMoa1102287 PMID: 22007715
23. The RTS,S Clinical Trials Partnership (2012) A phase 3 trial of RTS,S/AS01 malaria vaccine in African infants. N Engl J Med 367: 2284-95. doi: 10.1056/NEJMoa1208394 PMID: 23136909
24. Sun PF, 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-γ. J Immunol 171: 6961-7. PMID: 14662904
25. Lumsden JM, Schwenk RJ, Rein LE, Moris P, Janssens M, Ofori-Anyinam O, et al. (2011) Protective immunity induced with the RTS,S/AS vaccine is associated with IL-2 and TNF-α producing effector and central memory CD4 T cells. PLoS One 6: e20775. doi: 10.1371/journal.pone.0020775 PMID: 21779319
26. Pinder M, Reece WH, Plebanski M, Akinwunmi P, Flanagan KL, Lee EA, et al. (2004) Cellular immunity induced by the recombinant Plasmodium falciparum malaria vaccine, RTS,S/AS02, in semi-immune adults in The Gambia. Clin Exp Immunol 135: 286-93. PMID: 14738458
27. Lalvani A, Moris P, Voss G, Pathan AA, Kester KE, Brookes R, et al. (1999) 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: 1656-64. PMID: 10515829
28. Olotu A, Moris P, Mwacharo J, Vekemans J, Kimani D, Janssens M, et al. (2011) Circumsporozoite-specific T cell responses in children vaccinated with RTS,S/AS01E and protection against P falciparum clinical malaria. PLoS One 6: e25786. doi: 10.1371/journal.pone.0025786 PMID: 21998698
29. Ndungu FM, Mwacharo J, Kimani D, Kai O, Moris P, Jongert E, et al. (2012) A statistical interaction between circumsporozoite protein-specific T cell and antibody responses and risk of clinical malaria episodes following vaccination with RTS,S/AS01E. PLoS One 7: e52870. doi: 10.1371/journal.pone.0052870 PMID: 23300801
30. Radosević K, Rodriguez A, Lemckert A, Goudsmit J (2009) Heterologous prime-boost vaccinations for poverty-related diseases: advantages and future prospects. Expert Rev Vaccines 8: 577-92. doi: 10.1586/erv.09.14 PMID: 19397415
31. Lu S (2009) Heterologous prime-boost vaccination. Curr Opin Immunol 21: 346-51. doi: 10.1016/j.coi.2009.05.016 PMID: 19500964
32. Shott JP, McGrath SM, Pau MG, Custers JH, Ophorst O, Demoitie MA, et al. (2008) Adenovirus 5 and 35 vectors expressing Plasmodium falciparum circumsporozoite surface protein elicit potent antigen-specific cellular IFN-γ and antibody responses in mice. Vaccine 26: 2818-23. doi: 10.1016/j.vaccine.2008.03.080 PMID: 18455276
33. Ophorst OJ, Radošević K, Havenga MJ, Pau MG, Holterman L, Berkhout B, et al. (2006) Immunogenicity and protection of a recombinant human adenovirus serotype 35-based malaria vaccine against Plasmodium yoelii in mice. Infect Immun 74: 313-20. PMID: 16368986
34. Rodríguez A, Mintardjo R, Tax D, Gillissen G, Custers J, Pau MG, et al. (2009) Evaluation of a prime-boost vaccine schedule with distinct adenovirus vectors against malaria in rhesus monkeys. Vaccine 27: 6226-33. doi: 10.1016/j.vaccine.2009.07.106 PMID: 19686691
35. Stewart VA, McGrath SM, Dubois PM, Pau MG, Mettens P, Shott J, et al. (2007) Priming with an adenovirus 35-circumsporozoite protein (CS) vaccine followed by RTS,S/AS01 boosting significantly improves immunogenicity to Plasmodium falciparum CS compared to that with either malaria vaccine alone. Infect Immun 75: 2283-90. PMID: 17307942
36. Creech CB, Dekker CL, Ho D, Phillips S, Mackey S, Murray-Krezan C, et al. (2013) Randomized, placebo-controlled trial to assess the safety and immunogenicity of an adenovirus type 35-based circumsporozoite malaria vaccine in healthy adults. Hum Vaccin Immunother 9; 2548-57. doi: 10.4161/hv.26038 PMID: 23955431
37. Ouédraogo A, Tiono AB, Kargougou D, Yaro JB, Ouédraogo E (2013) A phase 1b randomized, controlled, double-blinded dosage-escalation trial to evaluate the safety, reactogenicity and immunogenicity of an adenovirus type 35 based circumsporozoite malaria vaccine in Burkinabe healthy adults 18 to 45 years of age. PLoS One Nov 11; 8(11):e78679. doi: 10.1371/journal.pone.0078679 PMID: 24244339
38. Clement F, Dewar V, Van Braeckel E, Desombere I, Dewerchin M, Swysen C, et al. (2012) Validation of an enzyme-linked immunosorbent assay for the quantification of human IgG directed against the repeat region of the circumsporozoite protein of the parasite Plasmodium falciparum. Malar J 11: 384. doi: 10.1186/1475-2875-11-384 PMID: 23173602
39. Olotu AI, Fegan G, Bejon P (2010) Further analysis of correlates of protection from a phase 2a trial of the falciparum malaria vaccines RTS,S/AS01 and RTS,S/AS02A in malaria-naive adults. J Infect Dis 201: 970-1. doi: 10.1086/651025 PMID: 20170369
40. White MT, Bejon P, Olotu A, Griffin JT, Riley EM, Kester K, et al. (2013) The Relationship between RTS,S Vaccine-Induced Antibodies, CD4 T Cell Responses and Protection against Plasmodium falciparum Infection. PLoS One 8: e61395. doi: 10.1371/journal.pone.0061395 PMID: 23613845
41. Dunachie SJ, Walther M, Vuola JM, Webster DP, Keating SM, Berthoud T, et al. (2006) A clinical trial of prime-boost immunization with the candidate malaria vaccines RTS,S/AS02A and MVA-CS. Vaccine 24: 2850-9. PMID: 16434127
42. Romero P, Maryanski JL, Corradin G, Nussenzweig RS, Nussenzweig V, Zavala F (1989) Cloned cytotoxic T cells recognize an epitope in the circumsporozoite protein and protect against malaria. Nature 341: 323-6. PMID: 2477703