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Hiv vaccine formulationsRelated Patent Categories: Chemistry: Molecular Biology And Microbiology, Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip, Involving Nucleic AcidHiv vaccine formulations description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060110736, Hiv vaccine formulations. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] The present invention relates generally to immunogenic HIV compositions, in particular to HIV vaccines and methods of formulating and administering these vaccines. BACKGROUND [0002] Acquired immune deficiency syndrome (AIDS) is recognized as one of the greatest health threats facing modern medicine. There is, as yet, no cure for this disease. [0003] In 1983-1984, three groups independently identified the suspected etiological agent of AIDS. See, e.g., Barre-Sinoussi et al. (1983) Science 220:868-871; Montagnier et al., in Human T-Cell Leukemia Viruses (Gallo, Essex & Gross, eds., 1984); Vilmer et al. (1984) The Lancet 1:753; Popovic et al. (1984) Science 224:497-500; Levy et al. (1984) Science 225:840-842. These isolates were variously called lymphadenopathy-associated virus (LAV), human T-cell lymphotropic virus type III (HTLV-III), or AIDS-associated retrovirus (ARV). All of these isolates are strains of the same virus, and were later collectively named Human Immunodeficiency Virus (HIV). With the isolation of a related AIDS-causing virus, the strains originally called HIV are now termed HIV-1 and the related virus is called HIV-2. See, e.g., Guyader et al. (1987) Nature 326:662-669; Brun-Vezinet et al. (1986) Science 233:343-346; Clavel et al. (1986) Nature 324:691-695. [0004] Since the implementation of highly active antiretroviral therapy (HAART) in the United States in 1996, the number of persons diagnosed with acquired immunodeficiency syndrome (AIDS) and the number of deaths among persons with AIDS have declined substantially (Karon et al. (2001) Am J Public Health 91(7):1060-1068) as a result, the number of persons living with AIDS has increased. The Centers for Disease Control (CDC) estimates that as of Dec. 31, 2000, approximately 340,000 persons in the United States were living with AIDS. (MMWR, Centers for Disease Control and Prevention. HIV/AIDS Surveillence Report, 13(No.1) 2001). [0005] Clinical trials in the US have been conducted with a limited number of subjects and further HIV vaccine development will require the identification of a suitable population where the HIV seroincidence is sufficiently high to enable a distinction between protection in the immunized population with a placebo control. Seage III et al. (2001) Am. J. Epidemiol. 153(7):619-627; Halpern et al. (2001) J Acquir Immune Defic Syndr 27(3):281-8. [0006] The primary mode of transmission of HIV is through sex and by contact with infected body fluids including blood, semen, vaginal fluid, breast milk, and other body fluids containing blood. In industrialized countries, the majority of cases reported in which the person's risk is known are among men who have sex with men. Before blood screening for antibodies to HIV was instituted, transfusion-associated HIV was a concern in the US. (CDC. Update: HIV-2 infection among blood and plasma donors--United States, June 1992-June 1995. MMWR, 1995. 44: p. 603-606). Other modes of transmission include needle sharing by injection drug users, inadvertent contact with infected blood among hospital workers, and rare iatrogenic transmission through the re-use of contaminated medical equipment. Higher rates of sexually transmitted infections signal a rise in unsafe sex practices. Chen et al. (2001) Am J Public Health 92(9):1387-1388. Heterosexual transmission of HIV-1 continues to rise, particularly among women, the young, and the economically disadvantaged and, in fact, heterosexual transmission is the dominant mode of transmission in the developing world. These trends highlight the need for the development of a preventive and/or therapeutic vaccine. Catania et al. (2001) Am J Public Health 91(6):907-914. [0007] Several targets for vaccine development have been examined, including the env and Gag gene products encoded by HIV. Gag gene products include, but are not limited to, Gag-polymerase (pol) and Gag-protease (prot). Env gene products include, but are not limited to, monomeric gp120 polypeptides, oligomeric gp140 polypeptides (o-gp140) and gp160 polypeptides. [0008] Recently, use of HIV Env polypeptides in immunogenic compositions has been described. (see, U.S. Pat. No. 5,846,546 to Hurwitz et al., issued Dec. 8, 1998, describing immunogenic compositions comprising a mixture of at least four different recombinant virus that each express a different HIV env variant; and U.S. Pat. No. 5,840,313 to Vahlne et al., issued Nov. 24, 1998, describing peptides which correspond to epitopes of the HIV-1 gp120 protein). In addition, U.S. Pat. No. 5,876,731 to Sia et al, issued Mar. 2, 1999 describes candidate vaccines against HIV comprising an amino acid sequence of a T-cell epitope of Gag linked directly to an amino acid sequence of a B-cell epitope of the V3 loop protein of an HIV-1 isolate containing the sequence GPGR. However, these groups did not identify an effective HIV vaccine. [0009] U.S. Pat. No. 6,602,705 and International Patent Publications WO 00/39302; WO 02104493; WO 00/39303; and WO 00/39304 describe polynucleotides encoding immunogenic HIV polypeptides from various subtypes. [0010] Thus, there remains a need for immunogenic HIV compositions, specifically for HIV vaccine formulations. SUMMARY [0011] In one aspect, the invention includes an HIV DNA vaccine composition comprising a nucleic acid expression vector (e.g., plasmid, viral vector, etc.) comprising at least one HIV Gag- or Env-encoding sequence and PLG. Preferably, the nucleic acid expression vector is adsorbed to the PLG. In certain embodiments, the concentration of PLG is between about 5 and 100 fold greater than the concentration of the nucleic acid expression vector. For example, the concentration of nucleic acid can be between about 10 .mu.g/mL and 5 mg/mL and the concentration of the PLG can be between about 100 .mu.g/mL and 100 mg/mL and/or the nucleic acid expression vector concentration per dose can be between approximately 1 .mu.g/dose and 5 mg/dose and the PLG concentration per dose can be between approximately 10 .mu.g/dose and 100 mg/dose. Specific formulations are described herein, for example, in Table 1, Table 2, or column 2 of Table 9. [0012] In another aspect, the invention includes an HIV vaccine composition comprising an HIV envelope protein, for example oligomeric gp140 (o-gp140); and a pharmaceutically acceptable excipient. In certain embodiments, the concentration of o-gp140 is between about 0.1 mg/mL and 10 mg/mL. Further, in certain embodiments, the concentration of o-gp140 per dose is approximately 100 .mu.g/dose. Specific formulations of HIV protein vaccines are also described herein, for example in Table 3 and Table 11. [0013] In another aspect, the invention comprises an HIV vaccine including one or more of the HIV DNA vaccines described herein (e.g., an HIV Gag DNA vaccine as described herein and an HIV Env DNA vaccine as described herein) and one or more of the HIV vaccines described herein (e.g., an HIV o-gp140 preparation). [0014] Any of the HIV vaccine compositions described herein may further include one or more adjuvants, for example MF59 or CpG. A particular formulation for MF59 is set forth in Table 4. [0015] In yet another aspect, the invention includes a method of generating an immune response in a subject, comprising (a) administering at least one HIV vaccine composition described herein to the subject, and (b) administering, at a time subsequent to the administering of step (a), at least one HIV vaccine composition described herein. In certain embodiments, the at least one HIV vaccine composition administered in step (a) comprises an HIV DNA vaccine (e.g., at least one HIV Gag vaccine and/or at least one HIV Env vaccine) as described herein and the HIV vaccine composition administered in step (b) comprises an HIV protein vaccine as described herein. Furthermore, step (a) may comprise multiple administrations of one or more HIV DNA vaccines as described herein (e.g., two or three administrations at one month intervals) and step (b) may comprise at least one administration of one or more HIV protein vaccines as described herein (e.g., two or three administrations at 1, 2, or 3 month intervals). Alternatively, step (b) may comprise concurrently administering at least one HIV DNA vaccine described herein (e.g., an HIV Gag vaccine and/or an HIV Env vaccine) and at least one and at least one HIV protein vaccine as described herein. The time between the administrations of step (a) and step (b) can vary, for example between 1 to 6 months or even longer. In any of the methods described herein, one or more administrations may be intramuscular and/or intradermal. [0016] In a further aspect, the invention includes a method of making oligomeric HIV Env gp140 proteins, comprising the steps of introducing a nucleic acid encoding gp140 into a host cell; culturing the host cell under conditions such that gp140. is expressed in the cell; and isolating oligomeric gp140 (o-gp140) protein from the host cell. In certain embodiments, the o-gp140 is secreted from the cell and isolated from the cell supernatant. [0017] In a still further aspect, a method of making any of the HIV DNA vaccines described herein is provided. The method comprises the step of combining a nucleic acid expression vector comprising a sequence encoding one or more HIV polypeptides with aseptic PLG microparticles such that the nucleic acid expression vector binds to the PLG microparticles to form a DNA/PLG HIV vaccine. In certain embodiments, the method further comprises the step of lyophilizing the DNA/PLG HIV vaccines. [0018] In another aspect, the invention includes a method of making an HIV protein vaccine as described herein, the method comprising the steps of combining o-gp140 with an adjuvant. [0019] These and other embodiments of the present invention will readily occur to those of ordinary skill in the art in view of the disclosure herein. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1A and FIG. 1B are graphs depicting the effect of PLG microparticles on anti-Gag antibody responses induced by DNA vaccines. FIG. 1A shows geometric mean ELISA titers of animals immunized with plasmid DNA at weeks 0, 4 and 14, then boosted at weeks 38 and 75 with recombinant Env protein formulated with MF59. FIG. 1B shows geometric mean titer of animals immunized with pSINCP DNA at weeks 0, 4 and 14, then boosted at weeks 38 and 75 with recombinant Env protein formulated with MF59. Anti-Gag antibodies are plotted as geometric mean ELISA titer for naked pCMV (solid symbols) and PLG/pCMV (open symbols) and error bars represent SEM. Continue reading about Hiv vaccine formulations... Full patent description for Hiv vaccine formulations Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Hiv vaccine formulations patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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