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Review

Safety and tolerability evaluation of the use of Montanide ISA™51 as vaccine adjuvant: A systematic review

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Pages 159-169 | Received 27 Apr 2015, Accepted 07 Jul 2015, Published online: 17 Sep 2015

References

  • WHO. Annex 1 - guidelines for the production and quality control of synthetic peptide vaccines. WHO Technical Report Studies 1999; 889:24-43
  • Wilson-Welder JH, Torres MP, Kipper MJ, Mallapragada SK, Wannemuehler MJ, Narasimhan B. Vaccine adjuvants: Current challenges and future approaches. J Pharm Sci 2009; 98:1278-316; PMID:18704954; http://dx.doi.org/10.1002/jps.21523
  • European Medicines Agency. Committee for medicinal products for human use guideline on adjuvants in vaccines for human use. 2004; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/11/WC500015469.pdf
  • Cox JV, Coulter AR. Adjuvants - a classification and review of their modes of action. Vaccine 1997; 15:248-56; PMID:9139482; http://dx.doi.org/10.1016/S0264-410X(96)00183-1
  • Aucouturier J, Dupuis L, Deville S, Ascarateil S, Ganne V. Montanide ISA 720 and 51: A new generation of water in oil emulsions as adjuvants for human vaccines. Expert Rev Vaccines 2002; 1:111-8; PMID:12908518; http://dx.doi.org/10.1586/14760584.1.1.111
  • Seppic. Montanide ISA 51 VG [Internet]. Paris (France): Seppic [cited 12 February 2014]. Available from http://www.seppic.com/human-health/vaccine390adjuvant/montanide-isa-@/1018/view-1042-seproduit.html.
  • Yamshchikov GV, Barnd DL, Eastham S, Galavotti H, Patterson JW, Deacon DH, Teates D, Neese P, Grosh WW, Petroni G, et al. Evaluation of peptide vaccine immunogenicity in draining lymph nodes and peripheral blood of melanoma patients. Int J Cancer 2001; 92:703-11; PMID:11340576; http://dx.doi.org/10.1002/1097-0215(20010601)92:5%3c703::AID-IJC1250%3e3.0.CO;2-5
  • Kaeberle M. Function of carriers and adjuvants in induction of immune responses. In: Nervig R, Gough P, Kaeberle M, Whetstone C, eds. Carriers and Adjuvants for Veterinary Biologics. USA: Iowa State University Press, 1986:11-23.
  • Aucouturier J, Dupuis L, Ganne V. Adjuvants designed for veterinary and human vaccines. Vaccine 2001; 19:2666-72; PMID:11257407; http://dx.doi.org/10.1016/S0264-410X(00)00498-9
  • Fox CB, Haensler J. An update on safety and immunogenicity of vaccines containing emulsion-based adjuvants. Expert Rev Vaccines 2013; 12:747-58; PMID:23885820; http://dx.doi.org/10.1586/14760584.2013.811188
  • Atsmon J, Kate-Ilovitz E, Shaikevich D, Singer Y, Volokhov I, Haim KY, Ben-Yedidia T. Safety and immunogenicity of multimeric-001 - A novel universal influenza vaccine. J Clin Immunol 2012; 32:595-603; PMID:22318394; http://dx.doi.org/10.1007/s10875-011-9632-5
  • Pleguezuelos O, Robinson S, Stoloff GA, Caparros-Wanderly W. Synthetic influenza vaccine (FLU-v) stimulates cell mediated immunity in a double-blind, randomized, placebo-controlled phase I trial. Vaccine 2012; 30:4655-60; PMID:22575166; http://dx.doi.org/10.1016/j.vaccine.2012.04.089
  • Gringeri A, Santagostino E, Muca-Perja M, Mannucci PM, Zagury JF, Bizzini B, Lachgar A, Carcagno M, Rappaport J, Criscuolo M, et al. Safety and immunogenicity of HIV-1 tat toxoid in immunocompromised HIV-1-infected patients. J Hum Virol 1998; 1:293-8; PMID:10195254
  • Slingluff Jr. CL, Lee S, Zhao F, Chianese-Bullock KA, Olson WC, Butterfield LH, Whiteside TL, Leming PD, Kirkwood JM. A randomized phase II trial of multiepitope vaccination with melanoma peptides for cytotoxic T cells and helper T cells for patients with metastatic melanoma (E1602). Clin Cancer Res 2013; 19:4228-38; PMID:23653149; http://dx.doi.org/10.1158/1078-0432.CCR-13-0002
  • Melanoma Study Group of the Mayo Clinic Cancer Center, Celis E. Overlapping human leukocyte antigen class I/II binding peptide vaccine for the treatment of patients with stage IV melanoma: Evidence of systemic immune dysfunction. Cancer 2007; 110:203-14; PMID:17541944; http://dx.doi.org/10.1002/cncr.22744
  • Georgoulias V, Douillard J-, Khayat D, Manegold C, Rosell R, Rossi A, Menez-Jamet J, Iche M, Kosmatopoulos K, Gridelli C. A multicenter randomized phase IIb efficacy study of vx-001, a peptide-based cancer vaccine as maintenance treatment in advanced non-small-cell lung cancer: Treatment rationale and protocol dynamics. Clin Lung Cancer 2013; 14:461-5; PMID:23647738; http://dx.doi.org/10.1016/j.cllc.2013.02.001
  • Chianese-Bullock KA, Pressley J, Garbee C, Hibbitts S, Murphy C, Yamshchikov G, Petroni GR, Bissonette EA, Neese PY, Grosh WW, et al. MAGE-A1-, MAGE-A10-, and gp100-derived peptides are immunogenic when combined with granulocyte-macrophage colony-stimulating factor and montanide ISA-51 adjuvant and administered as part of a multipeptide vaccine for melanoma. J Immunol 2005; 174:3080-6; PMID:15728523; http://dx.doi.org/10.4049/jimmunol.174.5.3080
  • Harris RC, Chianese-Bullock KA, Petroni GR, Schaefer JT, Brill II LB, Molhoek KR, Deacon DH, Patterson JW, Slingluff Jr. CL. The vaccine-site microenvironment induced by injection of incomplete freund's adjuvant, with or without melanoma peptides. J Immunother 2012; 35:78-88; PMID:22130163; http://dx.doi.org/10.1097/CJI.0b013e31823731a4
  • Miller JS, Curtsinger J, Berthold M, Malvey K, Bliss RL, Le CT, Fautsch SK, Dudek AZ, Blazar BR, Panoskaltsis-Mortari A. Diminished neo-antigen response to keyhole limpet hemocyanin (KLH) vaccines in patients after treatment with chemotherapy or hematopoietic cell transplantation. Clin Immunol 2005; 117:144-51; PMID:16112616; http://dx.doi.org/10.1016/j.clim.2005.07.005
  • Revicki DA, van den Eertwegh AJM, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, et al. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes 2012; 10:66; http://dx.doi.org/10.1186/1477-7525-10-66
  • Salerno EP, Shea SM, Olson WC, Petroni GR, Smolkin ME, McSkimming C, Chianese-Bullock KA, Slingluff Jr. CL. Activation, dysfunction and retention of T cells in vaccine sites after injection of incomplete freund's adjuvant, with or without peptide. Cancer Immunol Immunother 2013; 62:1149-59; PMID:23657629; http://dx.doi.org/10.1007/s00262-013-1435-5
  • Eikawa S, Kakimi K, Isobe M, Kuzushima K, Luescher I, Ohue Y, Ikeuchi K, Uenaka A, Nishikawa H, Udono H, et al. Induction of CD8 T-cell responses restricted to multiple HLA class i alleles in a cancer patient by immunization with a 20-mer NY-ESO-1f (NY-ESO-1 91-110) peptide. Int J Cancer 2013; 132:345-54; PMID:22729530; http://dx.doi.org/10.1002/ijc.27682
  • Oka Y, Tsuboi A, Murakami M, Hirai M, Tominaga N, Nakajima H, Elisseeva OA, Masuda T, Nakano A, Kawakami M, et al. Wilms tumor gene peptide-based immunotherapy for patients with overt leukemia from myelodysplastic syndrome (MDS) or MDS with myelofibrosis. Int J Hematol 2003; 78:56-61; PMID:12894852; http://dx.doi.org/10.1007/BF02983241
  • Saitoh A, Narita M, Watanabe N, Tochiki N, Yamahira A, Nakamura T, Kaji M, Masuko M, Furukawa T, Toba K, et al. WT1 peptide vaccination in a CML patient: Induction of effective cytotoxic T lymphocytes and significance of peptide administration interval. Med Oncol 2011; 28:219-30; PMID:20107936; http://dx.doi.org/10.1007/s12032-010-9425-3
  • Shirakata T, Oka Y, Nishida S, Hosen N, Tsuboi A, Oji Y, Murao A, Tanaka H, Nakatsuka S, Inohara H, et al. WT1 peptide therapy for a patient with chemotherapy-resistant salivary gland cancer. Anticancer Res 2012; 32:1081-5; PMID:22399636
  • Takahashi N, Ohkuri T, Homma S, Ohtake J, Wakita D, Togashi Y, Kitamura H, Todo S, Nishimura T. First clinical trial of cancer vaccine therapy with artificially synthesized helper/killer-hybrid epitope long peptide of MAGE-A4 cancer antigen. Cancer Sci 2012; 103:150-3; PMID:22221328; http://dx.doi.org/10.1111/j.1349-7006.2011.02106.x
  • Tsuboi A, Oka Y, Nakajima H, Fukuda Y, Elisseeva OA, Yoshihara S, Hosen N, Ogata A, Kito K, Fujiki F, et al. Wilms tumor gene WT1 peptide-based immunotherapy induced a minimal response in a patient with advanced therapy-resistant multiple myeloma. Int J Hematol 2007; 86:414-7; PMID:18192109; http://dx.doi.org/10.1007/BF02983998
  • Tsuboi A, Oka Y, Osaki T, Kumagai T, Tachibana I, Hayashi S, Murakami M, Nakajima H, Elisseeva OA, Fei W, et al. WT1 peptide-based immunotherapy for patients with lung cancer: Report of two cases. Microbiol Immunol 2004; 48:175-84; PMID:15031530; http://dx.doi.org/10.1111/j.1348-0421.2004.tb03503.x
  • Valmori D, Dutoit V, Ayyoub M, Rimoldi D, Guillaume P, Lienard D, Lejeune F, Cerottini J-, Romero P, Speiser DE. Simultaneous CD8+ T cell responses to multiple tumor antigen epitopes in a multipeptide melanoma vaccine. Cancer Immun 2003; 3:1-14
  • Wobser M, Keikavoussi P, Kunzmann V, Weininger M, Andersen MH, Becker JC. Complete remission of liver metastasis of pancreatic cancer under vaccination with a HLA-A2 restricted peptide derived from the universal tumor antigen survivin. Cancer Immunol Immunother 2006; 55:1294-8; PMID:16315030; http://dx.doi.org/10.1007/s00262-005-0102-x
  • Alvarez MC, Macias AA, Saurez MG, Fernandez ML, Lage DA. Bronchial carcinoid tumor treated with interferon and a new vaccine against NeuGcGM3 antigen expressed in malignant carcinoid cells. Cancer Biol Ther 2007; 6:853-5; PMID:17611391; http://dx.doi.org/10.4161/cbt.6.6.4186
  • Oji Y, Oka Y, Nishida S, Tsuboi A, Kawakami M, Shirakata T, Takahashi K, Murao A, Nakajima H, Narita M, et al. WT1 peptide vaccine induces reduction in minimal residual disease in an imatinib-treated CML patient. Eur J Haematol 2010; 85:358-60; PMID:20633041; http://dx.doi.org/10.1111/j.1600-0609.2010.01497.x
  • Maeda T, Hosen N, Fukushima K, Tsuboi A, Morimoto S, Matsui T, Sata H, Fujita J, Hasegawa K, Nishida S, et al. Maintenance of complete remission after allogeneic stem cell transplantation in leukemia patients treated with wilms tumor 1 peptide vaccine. Blood Cancer J 2013; 3:e130; PMID:23912610; http://dx.doi.org/10.1038/bcj.2013.29
  • Maslak PG, Dao T, Gomez M, Chanel S, Packin J, Korontsvit T, Zakhaleva V, Pinilla-Ibarz J, Berman E, Scheinberg DA. A pilot vaccination trial of synthetic analog peptides derived from the BCR-ABL breakpoints in CML patients with minimal disease. Leukemia 2008; 22:1613-6; PMID:18256684; http://dx.doi.org/10.1038/leu.2008.7
  • Pinto LA, Berzofsky JA, Fowke KR, Little RF, Merced-Galindez F, Humphrey R, Ahlers J, Dunlop N, Cohen RB, Steinberg SM, et al. HIV-specific immunity following immunization with HIV synthetic envelope peptides in asymptomatic HIV-infected patients. AIDS 1999; 13:2003-12; PMID:10546852; http://dx.doi.org/10.1097/00002030-199910220-00002
  • Boffito M, Fox J, Bowman C, Fisher M, Orkin C, Wilkins E, Jackson A, Pleguezuelos O, Robinson S, Stoloff GA, et al. Safety, immunogenicity and efficacy assessment of HIV immunotherapy in a multi-centre, double-blind, randomised, placebo-controlled phase ib human trial. Vaccine 2013; 31:5680-6; PMID:24120550; http://dx.doi.org/10.1016/j.vaccine.2013.09.057
  • Sabbatini P, Tsuji T, Ferran L, Ritter E, Sedrak C, Tuballes K, Jungbluth AA, Ritter G, Aghajanian C, Bell-McGuinn K, et al. Phase I trial of overlapping long peptides from a tumor self-antigen and poly-ICLC shows rapid induction of integrated immune response in ovarian cancer patients. Clin Cancer Res 2012; 18:6497-508; PMID:23032745; http://dx.doi.org/10.1158/1078-0432.CCR-12-2189
  • Goldinger SM, Dummer R, Baumgaertner P, Mihic-Probst D, Schwarz K, Hammann-Haenni A, Willers J, Geldhof C, Prior JO, Kundig TM, et al. Nano-particle vaccination combined with TLR-7 and -9 ligands triggers memory and effector CD8+ T-cell responses in melanoma patients. Eur J Immunol 2012; 42:3049-61; PMID:22806397; http://dx.doi.org/10.1002/eji.201142361
  • National Cancer Institute. Evaluation of the impact of adjuvants accompanying peptide immunization in high-risk melanoma (NCT00273910). United Staes of America: U.S. National Institutes of Health [cited 15 February 2014]. Available from https://clinicaltrials.gov/ct2/show/NCT00273910?term=NCT00273910&rank=1.
  • Graham BS, Mcelrath MJ, Keefer MC, Rybczyk K, Berger D, Weinhold KJ, Ottinger J, Ferarri G, Montefiori DC, Stablein D, et al. Immunization with cocktail of HIV-derived peptides in montanide ISA-51 is immunogenic, but causes sterile abscesses and unacceptable reactogenicity. PLoS ONE 2010; 5:e11995; http://dx.doi.org/10.1371/journal.pone.0011995
  • Herrera S, Fernandez OL, Vera O, Cardenas W, Ramirez O, Palacios R, Chen-Mok M, Corradin G, Arevalo-Herrera M. Phase I safety and immunogenicity trial of plasmodium vivax CS derived long synthetic peptides adjuvanted with montanide ISA 720 or montanide ISA 51. Am J Trop Med Hyg 2011; 84:12-20; PMID:21292873; http://dx.doi.org/10.4269/ajtmh.2011.09-0516
  • Pialoux G, Excler J-, Riviere Y, Gonzalez-Canali G, Feuillie V, Coulaud P, Gluckman J-, Matthews TJ, Meignier B, Kieny M-, et al. A prime-boost approach to HIV preventive vaccine using a recombinant canarypox virus expressing glycoprotein 160 (MN) followed by a recombinant glycoprotein 160 (MN/LAI). AIDS Res Hum Retroviruses 1995; 11:373-81; PMID:7598771; http://dx.doi.org/10.1089/aid.1995.11.373
  • Wu Y, Ellis RD, Shaffer D, Fontes E, Malkin EM, Mahanty S, Fay MP, Narum D, Rausch K, Miles AP, et al. Phase 1 trial of malaria transmission blocking vaccine candidates Pfs25 and pvs 25 formulated with montanide ISA 51. PLoS ONE 2008; 3:e2636; http://dx.doi.org/10.1371/annotation/c1aa88dd-4360-4902-8599-4d7edca79817
  • Carr A, Rodriguez E, Arango MDC, Camacho R, Osorio M, Gabri M, Carrillo G, Valdes Z, Bebelagua Y, Perez R, et al. Immunotherapy of advanced breast cancer with a heterophilic ganglioside (NeuGcGM3) cancer vaccine. J Clin Oncol 2003; 21:1015-21; PMID:12637465; http://dx.doi.org/10.1200/JCO.2003.02.124
  • Mulens V, De La Torre A, Marinello P, Rodriguez R, Cardoso J, Diaz R, O'Farrill M, Macias A, Viada C, Saurez G, et al. Immunogenicity and safety of a NeuGcGM3 based cancer vaccine: Results from a controlled study in metastatic breast cancer patients. Hum Vaccines 2010; 6:736-44; http://dx.doi.org/10.4161/hv.6.9.12571
  • Malkin EM, Durbin AP, Diemert DJ, Sattabongkot J, Wu Y, Miura K, Long CA, Lambert L, Miles AP, Wang J, et al. Phase 1 vaccine trial of Pvs25H: A transmission blocking vaccine for plasmodium vivax malaria. Vaccine 2005; 23:3131-8; PMID:15837212; http://dx.doi.org/10.1016/j.vaccine.2004.12.019
  • Higgins JPT, Altman DG, Sterne JAC. Assessing risk of bias in included studies. In: Cochrane Handbook for Systemic Reviews of Interventions [Internet]. Higgins JPT, Green S, eds. [2011, cited 10 December 2014]. Available from http://handbook.cochrane.org/.
  • Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials 1996; 17:1-12; PMID:8721797; http://dx.doi.org/10.1016/0197-2456(95)00134-4

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