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(12) Patent Application Publication (10) Pub. No.: US 2004/0047882 A1 Broeker (43) Pub US 20040047882A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0047882 A1 Broeker (43) Pub. Date: Mar. 11, 2004 (54) ADJUVANT FOR VACCINES (30) Foreign Application Priority Data (76) Inventor: Michael Broeker, Marburg (DE) Mar. 14, 2000 (DE).......................................... 1OO1237O. Correspondence Address: Publication Classification AlisaChiron A CorporationHarbin (51)51) Int. Cl.C.7 ....................... A61K 48700:700; A61K 39/145:/145; Intellectual Property R338 A61K 31/739 PO Box 8097 (52) U.S. Cl. ............................ 424/206.1; 514/54, 514/44 (21) Appl. No.: 10/221,941 Vaccine containing a first vaccine, adjuvated with an oil-in water emulsion comprising 5% Squalene, 0.5% polySorbate 80 and 0.5% sorbitan trioleate in aqueous citrate buffer pH (22) PCT Filed: Mar. 14, 2001 6.5, and a nonadjuvated Second vaccine as combination partners for the Simultaneous, Separate or phased application for immunization against Viral, bacterial or parasitic infec (86) PCT No.: PCT/EP01/02866 tious diseases. US 2004/0047882 A1 Mar. 11, 2004 ADJUVANT FOR WACCINES 0007. The invention in question is based on the surprising and unexpected discovery that the Spatially Separate con 0001. The invention involves the use of an oil-in-water secutive or simultaneous application of MF59 or of a emulsion as an adjuvant to be applied contralaterally. The vaccine, adjuvated with MF59, produces a synergistic effect invention especially involves vaccines containing a first on the antigenicity/immunogenicity of a Second vaccine, not vaccine, adjuvated with an oil-in-water emulsion, and a Second vaccine, not adjuvated with this adjuvant, as com adjuvated with MF59, in humans. bination partners for the Simultaneous, Separate or phased 0008 Based on the mode of action of MF59 discussed in application for therapy or prophylaxis. The invention very the literature, this effect should not be expected. It should especially involves combinations of an influenza vaccine, thus be noted that the mechanism of action for MF59 has not adjuvated with MF59, and a second vaccine. yet been thoroughly clarified. 0002) Numerous vaccine formulations containing attenu 0009. Although a stimulation of cytokine synthesis, espe ated pathogens or protein Subunit antigens have So far been cially of IL-5 and IL-6, has been discussed (e.g. Cellular developed. Conventional vaccine preparations usually con Immunology, 186 (1998), pages 18-27), it has been shown tain adjuvants to Strengthen the immune response. For in particular that MF59 affects the recruiting and activation example, depot-forming adjuvants are frequently used, of antigen-presenting cells Such as dendritic cells in muscle, which absorb and/or precipitate the administered antigen for example, which take up the antigen, migrate to the and form a depot at the injection Site. Typical depot-forming draining lymph nodes and efficiently present the processed adjuvants include aluminum compounds (alum) and water antigen to the T-lymphocytes, which should at least Suggest in-oil emulsions. However, although depot-forming adju that a certain Spatial proximity to the application site of Vants increase the antigenicity, they frequently cause Severe, adjuvant or antigen should be present in the muscle. AS persistent local reactions Such as granulomas, abscesses and mentioned above, although the Spatially Separate application cicatrices if they are applied Subcutaneously or intramuscu of MF59 and antigen in an animal experiment resulted in an larly. adjuvation (Stimulation of antigenicity/immunogenicity), the effects found with the contralateral application in 0003. On injection, other adjuvants such as lipopolysac humans are even more amazing if one considers-as the charides and muramyl dipeptides can cause pyrogenic reac Specialist is adequately aware-that it is not possible to tions or Reiter's Syndrome with flu-like Symptoms, gener extrapolate the results obtained with adjuvants in an animal alized arthralgia and Sometimes also anterior uveitis, experiment involving Small mammals, in particular, to large arthritis and urethritis. Saponins, Such as those from Quillaia mammals, not to mention humans. This should be taken into Saponaria, have likewise been used as adjuvants in VaccineS. consideration, especially for contralateral application, Since 0004 MF59, an immunostimulating Submicron oil-in Spatial Separation in Small mammals is of course not as water emulsion having a safe application, has recently been obvious. developed for use in vaccine formulations, See e.g. Ott et al., 0010. The contralateral simultaneous application of the “MF59Design and Evaluation of a Safe and Potent Adjuvant two vaccines, one of which is adjuvated with MF59 and the for Human Vaccines” in Vaccine Design: The Subunit and other is not adjuvated with MF59, is the preferred embodi Adjuvant Approach (Powell, M. F. and Newman, M. J., ment of the invention in question. “Contralateral,” as used in editors) Plenum Press, New York, 1995, pages 277-296. So the description in question and in the claims, is defined as the far only aluminum salts and MF59 have been licensed for application on opposite Sides of the body, Such as e.g. use as adjuvants for formulating vaccines for application in usually in the deltoid (musculus deltoides) of the right and humans. left arm. 0005 Adjuvants can act in various ways; they can influ 0011. The application can take place consecutively or ence the cytokine network, direct antigens to potent antigen Simultaneously, Simultaneous application being preferred. presenting cells, induce cytotoxic T-lymphocytes or prolong the release of the antigen Via depot formation. The conven 0012. The oil-in-water emulsion preferably used as adju tional application of adjuvants and vaccines usually takes vant is MF59, whose composition and preparation is place at the same time and place So as to increase an immune described as follows: response to the applied antigen. 0013 MF59 0006 For MF59 a temporal and spatial separation of the 0014) 1. squalene (2, 6, 10, 15, 23-hexamethyl-2, 6, application of antigen and adjuvant in an animal experiment 10, 14, 18, 22-tetracosahexane), about 5% (39 has been described, although without Specific data on the mg/ml) various application sites (Dupuis et al., Vaccine 18 (2000), 0.015 2. polysorbate 80 (Tween(E) 80), approx. 0.5% 434-439, Dupuis et al., Cellular Immunology 186 (1998), (4.7 mg/ml) 18-27 and Ott et al., “MF59-Design and Evaluation of a Safe and Potent Adjuvant for Human Vaccines: in Vaccine 0016 3. Sorbitan trioleate 85 (Span(R) 85), approx. Design: The Subunit and Adjuvant Approach (Powell, M. F. 0.5% (4.7 mg/ml) and Newman, M. F., editors) Plenum Press, New York, 1995, pages 277-296), which nonetheless resulted in an increase in 0.017. 4. citrate buffer pH 6.5 (trisodium citrate the applied immunity/antigenicity of the temporally and/or dihydrate, citric acid monohydrate, water for injec Spatially separate antigens. However, a (simultaneous) con tion) tralateral application of MF59 or a vaccine, adjuvated with 0018 MF59 is prepared in a perse known manner (Ott et MF59, in combination with a second vaccine, not adjuvated al., “MF59-Design and Evaluation of a Safe and Potent with MF59, has not yet been described. Adjuvant for Human Vaccines” in Vaccine Design: The US 2004/0047882 A1 Mar. 11, 2004 Subunit and Adjuvant Approach (Powell, M. F. and New Surrounded by a shell. The antigens hemagglutinin (HA) and man, M. J., editors) Plenum Press, New York, 1995, pages neuraminidase (NA) are integrated on the outside of the 277-296). shell. These two antigens sit on the particle Surface like fungiform Spikes. HA and NA are important for the adhesion 0019 Polysorbate 80 is dissolved in water for injection and intracellular penetration of the virus. For the influenza and Sodium citrate buffer is added. Sorbitan trioleate is virus that can infect humans, three HA serotypes (H1, H2 dissolved in Squalene Separately. These two Solutions are and H3) and two NA types (NA1 and NA2) are known. combined, and an emulsion is prepared in a homogenizer Extensive preclinical and clinical Studies have shown that (microfluidizer). After filtration through a 22 um filter and HA is capable of inducing protective, virus-neutralizing removal of larger drops under nitrogen treatment, the result antibodies. is a milky, white, Stable emulsion, which contains essentially particles having a diameter <1.2 lim. The resulting emulsion 0023 Influenzavirus is distinguished by a genetic pecu can be admixed to the vaccine to be adjuvated either while liarity: The viral ribonucleic acid (RNA) is divided into eight the vaccine is being prepared or Shortly before it is applied, Segments, which can be passed on Separately to the viral Such as e.g. in the formulation with the recombinant Surface progeny. This makes possible an arbitrary new combination glycoprotein gp120 of human immunodeficiency virus among Viral particles of a virus type. Virus type A is Subject (HIV), to prevent changes in confirmation. A proximal to the phenomenon of antigen change via antigen drift and application of antigen and MF59 is also possible. antigen shift. Antigen drift is defined as a point mutation in the HA gene. New drift variants are responsible for the 0020 “Vaccine,” as used in the description and the appearance of epidemics. Antigen shift is defined as the claims, is defined as viral, bacterial or parasitic antigens. eXchange of larger gene Segments between different animal They can exist in the form of whole-cell viruses, bacteria, and human influenza Strains (reassortment of RNA seg parasites, protein Subunits, polysaccharides, polysaccharide ments). In 1957 the surface antigens H1N1 developed into conjugates and nucleic acids. They can be used without H2N2 via exchange of homologous RNA segments between modification in galenic form or in combination with Vehicles human and animal influenzavirus strains, and in 1968 H2N2 or carrierS Such as e.g. microSpheres, liposomes, nano developed into H3N2. Viral flu is a highly contagious spheres, ISCOMS and other antigen delivery systems famil disease occurring throughout the World, which is typically iar to the Specialist.
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