Liposome-based cationic adjuvant formulations (CAF): Past, present, and future

References

• Agger EM, Andersen P. (2001). Tuberculosis subunit vaccine development: on the role of interferon-[gamma]. Vaccine 19(17–19):2298–2302.
   Google Scholar
• Agger EM, Cassidy JP, et al. (2008a). Adjuvant modulation of the cytokine balance in Mycobacterium tuberculosis subunit vaccines; immunity, pathology, and protection. Immunology 124:175–185.
   PubMed Web of Science ®Google Scholar
• Agger EM, Rosenkrands I, et al. (2008b). Cationic liposomes formulated with synthetic mycobacterial cordfactor (CAF01): a versatile adjuvant for vaccines with different immunological requirements. PLoS ONE 3:e3116.
   PubMed Web of Science ®Google Scholar
• Agger EM, Rosenkrands I, et al. (2006). Protective immunity to tuberculosis with Ag85B-ESAT-6 in a synthetic cationic adjuvant system IC31. Vaccine 24:5452–5460.
   PubMed Web of Science ®Google Scholar
• Allison AG, Gregoriadis G. (1974). Liposomes as immunological adjuvants. Nature 252:252.
   PubMed Web of Science ®Google Scholar
• Andersen CS, Agger EM,et al. (2009). A Simple mycobacterial monomycolated glycerol lipid has potent immunostimulatory activity. J Immunol 182(1): 424–432.
   Google Scholar
• Andersen CS, Rosenkrands, I et al. (Submitted). Novel generation mycobacterial adjuvant based on liposome encapsulated monomyco-lyl glycerol from M. bovis BCG.
   Google Scholar
• Babiak A, Werninghaus K,et al. (Submitted). The adjuvants TDB and TDM activate the Syk-Card9-Pathway for protection against tuberculosis.
   Google Scholar
• Bekierkunst A, Yarkoni E, et al. (1971). Immune response to sheep red blood cells in mice pretreated with mycobacterial fractions. Infect Immun 4:256–263.
   PubMed Web of Science ®Google Scholar
• Brunel F, Darbouret A, et al. (1999). Cationic lipid DC-Chol induces an improved and balanced immunity able to overcome the unresponsiveness to the hepatitis B vaccine. Vaccine 17:2192–2203.
   PubMed Web of Science ®Google Scholar
• Carmona-Rribeiro AM, Chaimovich H. (1983). Preparation and characterization of large dioctadecyldimethylammonium chloride liposomes and comparison with small sonicated vesicles. Biochim Biophys Acta 733:172–179.
   Google Scholar
• Carmona-Ribeiro AM, Yoshida LS, et al. (1984). Permeabilities and stabilities of large dihexadecylphosphate and dioctadecyldimethylammonium chloride vesicles. J Coll Interf Sci 100:433–443.
   Web of Science ®Google Scholar
• Christensen D, Foged C, et al. (2007a). Trehalose preserves DDA/TDB liposomes and their adjuvant effect during freeze-drying. Biochim Biophys Acta 1768:2120–2129.
   PubMed Web of Science ®Google Scholar
• Christensen D, Kirby D, et al. (2008). alpha,alpha’-trehalose 6,6’-dibehenate in non-phospholipid-based liposomes enables direct interaction with trehalose, offering stability during freeze-drying. Biochim Biophys Acta 1778:1365–1373.
   PubMed Web of Science ®Google Scholar
• Christensen D, Korsholm KS, et al., (2007b). Cationic liposomes as vaccine adjuvants. Exp Rev Vaccines 6:785–796.
   PubMed Web of Science ®Google Scholar
• Coelho EA, Tavares CA, et al. (2006). Mycobacterium hsp65 DNA entrapped into TDM-loaded PLGA microspheres induces protection in mice against Leishmania (Leishmania) major infection. Parasitol Res 98:568–575.
   PubMed Web of Science ®Google Scholar
• Davidsen J, Rosenkrands I, et al. (2006). Compositions and Methods for Stabilizing Lipid-based Adjuvant Formulations using Glycolipids. World, Statens Serum Institut.
   Google Scholar
• Davidsen J, Rosenkrands I, et al. (2005). Characterization of cationic liposomes based on dimethyldioctadecylammonium and synthetic cord factor from M. tuberculosis (trehalose 6,6’-dibehenate)—a novel adjuvant inducing both strong CMI and antibody responses. Biochim Biophys Acta 1718(1–2):22–31.
   Google Scholar
• EMEA. (July 2005). Guideline on Adjuvants in Vaccines for Human Use.
   Google Scholar
• EMEA. (June 1998). Note for guidance on preclinical pharmacological and toxicological testing of vaccines.
   Google Scholar
• Franchi L, Park J-H, et al. (2008). Intracellular NOD-like receptors in innate immunity, infection, and disease. Cell Microbiol 10:1–8.
   PubMed Web of Science ®Google Scholar
• Gall D. (1966). The adjuvant activity of aliphatic nitrogenous bases. Immunology 11:369–386.
   PubMed Web of Science ®Google Scholar
• Gregoriadis G, Leathwood PD, et al. (1971). Enzyme entrapment in liposomes. FEBS Lett 14:95–99.
   PubMed Web of Science ®Google Scholar
• Gregoriadis G, Ryman BE. (1972). Fate of protein-containing liposomes injected into rats. An approach to the treatment of storage diseases. Eur J Biochem 24:485–491.
   PubMedGoogle Scholar
• Hansen J, Jensen KT, et al. (2008). Liposome delivery of Chlamydia muridarum major outer membrane protein primes a Th1 response that protects against genital chlamydial infection in a mouse model. J Infect Dis 198:758–767.
   PubMed Web of Science ®Google Scholar
• Hilgers LA, Snippe H. (1992). DDA as an immunological adjuvant. Res Immunol 143:494–503; discussion, 574–576.
   PubMedGoogle Scholar
• Hilgers LA, Snippe H, et al. (1985). Combinations of two synthetic adjuvants: synergistic effects of a surfactant and a polyanion on the humoral immune response. Cell Immunol 92:203–209.
   PubMedGoogle Scholar
• Hilgers LA, Weststrate MW. (1991). Stabilized Adjuvant Suspension comprising Dimethyl Dioctadecyl Ammonium Bromide. D. I. R. B.V. Netherlands, Duphar International Research B.V.
   Google Scholar
• Hunter RL, Olsen M, et al. (2006a). Trehalose 6,6’-dimycolate and lipid in the pathogenesis of caseating granulomas of tuberculosis in mice. Am J Pathol 168:1249–1261.
   PubMed Web of Science ®Google Scholar
• Hunter RL, Olsen MR, et al. (2006b). Multiple roles of cord factor in the pathogenesis of primary, secondary, and cavitary tuberculosis, including a revised description of the pathology of secondary disease. Ann Clin Lab Sci 36:371–386.
   PubMedGoogle Scholar
• Hunter RL, Venkataprasad N, et al. (2006c). The role of trehalose dimycolate (cord factor) on morphology of virulent M. tuberculosis in vitro. Tuberculosis (Edinb) 86:349–356.
   PubMedGoogle Scholar
• ICH. (June 2001). S7A: Safety Pharmacology Studies for Human Pharmaceuticals.
   Google Scholar
• ICH. (March 1998). S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.
   Google Scholar
• ICH. (November 2000). M3: Nonclinical Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.
   Google Scholar
• Joseph A, Itskovitz-Cooper N, et al. (2006). A new intranasal influenza vaccine based on a novel polycationic lipid—ceramide carbamoyl-spermine (CCS) I. Immunogenicity and efficacy studies in mice. Vaccine 24:3990–4006.
   PubMed Web of Science ®Google Scholar
• Kanazawa N. (2007). Dendritic cell immunoreceptors: C-type lectin receptors for pattern-recognition and signaling on antigen-presenting cells. J Dermatol Sci 45:77–86.
   PubMed Web of Science ®Google Scholar
• Kawai T, Akira S. (2006). TLR signaling. Cell Death Differ 13:816–825.
   PubMed Web of Science ®Google Scholar
• Kirby DJ, Rosenkrands I, et al. (2008a). Liposomes act as stronger subunit vaccine adjuvants when compared to microspheres. J Drug Target 16:543–554.
   PubMed Web of Science ®Google Scholar
• Kirby DJ, Rosenkrands I, et al. (2008b). PLGA microspheres for the delivery of a novel subunit TB vaccine. J Drug Target 16:282–293.
   PubMed Web of Science ®Google Scholar
• Kirschning CJ, Bauer S. (2001). Toll-like receptors: cellular signal transducers for exogenous molecular patterns causing immune responses. Int J Med Microbiol 291:251–260.
   PubMed Web of Science ®Google Scholar
• Korsholm KS, Agger EM, et al. (2007). The adjuvant mechanism of cationic dimethyldioctadecylammonium liposomes. Immunology 121:216–226.
   PubMed Web of Science ®Google Scholar
• Kuramoto T, Nishikawa M, et al. (2006). Use of lipoplex-induced nuclear factor-kappaB activation to enhance transgene expression by lipoplex in mouse lung. J Gene Med 8:53–62.
   PubMed Web of Science ®Google Scholar
• Lee RE, Brennan PJ, et al. (1996). Mycobacterium tuberculosis cell envelope. Curr Top Microbiol Immunol 215:1–27.
   PubMed Web of Science ®Google Scholar
• Lima VM, Bonato VL, et al. (2001). Role of trehalose dimycolate in recruitment of cells and modulation of production of cytokines and NO in tuberculosis. Infect Immun 69:5305–5312.
   PubMed Web of Science ®Google Scholar
• Lindblad EB, Elhay MJ, et al. (1997). Adjuvant modulation of immune responses to tuberculosis subunit vaccines. Infect Immun 65:623–629.
   PubMed Web of Science ®Google Scholar
• Lindenstrøm T, Agger EM, et al. (Submitted). Tuberculosis subunit vaccination provides long-term protective immunity characterised by multifunctional CD4 memory T cells.
   Google Scholar
• Lonez C, Vandenbranden M, et al. (2008). Cationic liposomal lipids: from gene carriers to cell signaling. Prog Lipid Res 47:340–347.
   PubMed Web of Science ®Google Scholar
• Masihi KN, Bhaduri CR, et al. (1986a). Effects of muramyl dipeptide and trehalose dimycolate on resistance of mice to Toxoplasma gondii and Acanthamoeba culbertsoni infections. Int Arch Allergy Appl Immunol 81:112–117.
   Google Scholar
• Masihi KN, Brehmer W, et al. (1984a). Stimulation of chemiluminescence and resistance against aerogenic influenza virus infection by synthetic muramyl dipeptide combined with trehalose dimycolate. Infect Immun 43:233–237.
   Google Scholar
• Masihi KN, Brehmer W, et al. (1984b). Protective effect of muramyl dipeptide analogs in combination with trehalose dimycolate against aerogenic influenza virus and Mycobacterium tuberculosis infections in mice. J Biol Response Mod 3:663–671.
   Google Scholar
• Masihi KN, Lange W, et al. (1986b). Immunobiological activities of nontoxic lipid A: enhancement of nonspecific resistance in combination with trehalose dimycolate against viral infection and adjuvant effects. Int J Immunopharmacol 8:339–345.
   PubMed Web of Science ®Google Scholar
• McBride BW, Mogg A, et al. (1998). Protective efficacy of a recombinant protective antigen against Bacillus anthracis challenge and assessment of immunological markers. Vaccine 16:810–817.
   PubMed Web of Science ®Google Scholar
• Mitchell LA, Joseph A, et al. (2006). Mucosal immunization against hepatitis A: antibody responses are enhanced by coadministration of synthetic oligodeoxynucleotides and a novel cationic lipid. Vaccine 24:5300–5310.
   PubMed Web of Science ®Google Scholar
• Mohammed AR, Bramwell VW, et al. (2006). Lyophilisation and sterilisation of liposomal vaccines to produce stable and sterile products. Methods 40:30–38.
   PubMed Web of Science ®Google Scholar
• Olds GR, Chedid L, et al. (1980). Induction of resistance to Schistosoma mansoni by natural cord factor and synthetic lower homologues. J Infect Dis 141:473–478.
   PubMed Web of Science ®Google Scholar
• Olsen AW, Williams A, et al. (2004). Protective effect of a tuberculosis subunit vaccine based on a fusion of antigen 85B and ESAT-6 in the aerosol guinea pig model. Infect Immun 72:6148–6150.
   PubMed Web of Science ®Google Scholar
• Perrie Y, Mohammed AR, et al. (2008). Vaccine adjuvant systems: enhancing the efficacy of subunit protein antigens. Int J Pharmaceut 364:272–280.
   PubMed Web of Science ®Google Scholar
• Pimm MV, Baldwin RW, et al. (1979). Immunotherapy of an ascitic rat hepatoma with cord factor (trehalose-6,6’-dimycolate) and synthetic analogues. Int J Cancer 24:780–785.
   PubMed Web of Science ®Google Scholar
• Rosenkrands I, Agger EM, et al. (2005). Cationic liposomes containing mycobacterial lipids: a new powerful Th1 adjuvant system. Infect Immun 73:5817–5826.
   PubMed Web of Science ®Google Scholar
• Ryll R, Watanabe K, et al. (2001). Mycobacterial cord factor, but not sulfolipid, causes depletion of NKT cells and upregulation of CD1d1 on murine macrophages. Microbes Infect 3:611–619.
   PubMed Web of Science ®Google Scholar
• Sanchez V, Gimenez S, et al. (2001). Formulations of single or multiple H. pylori antigens with DC Chol adjuvant induce protection by the systemic route in mice. Optimal prophylactic combinations are different from therapeutic ones. FEMS Immunol Med Microbiol 30:157–165.
   PubMedGoogle Scholar
• Setia S, Mainzer H, et al. (2002). Frequency and causes of vaccine wastage. Vaccine 20(7–8):1148–1156.
   Google Scholar
• Silva CL, Ekizlerian SM, et al. (1985). Role of cord factor in the modulation of infection caused by mycobacteria. Am J Pathol 118:238–247.
   PubMed Web of Science ®Google Scholar
• Stanfield JP, Gall D, et al. (1973). Single-dose antenatal tetanus immunisation. Lancet 301(7797):215–219.
   Google Scholar
• Tanaka T, Legat A, et al. (2008). DiC14-amidine cationic liposomes stimulate myeloid dendritic cells through toll-like receptor 4. Eur J Immunol 38:1351–1357.
   PubMed Web of Science ®Google Scholar
• Vangala A, Bramwell VW, et al. (2007). Comparison of vesicle based antigen delivery systems for delivery of hepatitis B surface antigen. J Cont Rel 119:102–110.
   PubMed Web of Science ®Google Scholar
• Vangala A, Kirby D, et al. (2006). A comparative study of cationic liposome and niosome-based adjuvant systems for protein subunit vaccines: characterisation, environmental scanning electron microscopy, and immunisation studies in mice. J Pharm Pharmacol 58:787–799.
   PubMed Web of Science ®Google Scholar
• Vangasseri DP, Cui Z, et al. (2006). Immunostimulation of dendritic cells by cationic liposomes. Mol Membr Biol 23:385–395.
   PubMed Web of Science ®Google Scholar
• Veronesi R, Correa A, et al. (1970). Single-dose immunization against tetanus. Promising results in human trials. Rev Inst Med Trop (Sao Paulo) 12:46–54.
   PubMedGoogle Scholar
• Vipond J, Clark SO, et al. (2006). Reformulation of selected DNA vaccine candidates and their evaluation as protein vaccines using a guinea pig aerosol infection model of tuberculosis. Tuberculosis (Edinb) 86(3–4):218–224.
   Google Scholar
• WHO (2003). Report: Monitoring Vaccine Wastage at Country Level.
   Google Scholar
• WHO (2008). Report: Global Tuberculosis Control—Surveillance, Planning, Financing.
   Google Scholar
• Woodard LF, Toone NM, et al. (1980). Comparison of muramyl dipeptide, trehalose dimycolate, and dimethyl dioctadecyl ammonium bromide as adjuvants in Brucella abortus 45/20 vaccines. Infect Immun 30:409–412.
   PubMed Web of Science ®Google Scholar
• Yarkoni E, Rapp HJ, et al. (1978). Immunotherapy with an intralesionally administered synthetic cord factor analogue. Int J Cancer 22:564–569.
   PubMed Web of Science ®Google Scholar
• Zaks K, Jordan M, et al. (2006). Efficient immunization and cross-priming by vaccine adjuvants containing TLR3 or TLR9 agonists complexed to cationic liposomes. J Immunol 176:7335–7345.
   PubMed Web of Science ®Google Scholar