      Document 0071
 DOCN  DRG0071
 UNIQUE IDENTIFIER        DRG-0176
 NAME OF SUBSTANCE        MF59 [Int Conf AIDS 1993 Jun
                          6-11;9(1):(abstract no. WS-B27-2)]
 SYNONYMS                 MF-59 [Ann NY Acad Sci 1995 May 31;754]
 PROTOCOL ID NUMBERS      NIAID VEU 005
 PROTOCOL ID NUMBERS      NIAID VEU 015
 PROTOCOL ID NUMBERS      NIAID ACTG 214
 PROTOCOL ID NUMBERS      NIAID VEU 024
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: The mechanisms in which
                          adjuvants augment vaccine immunogenicity may
                          include 1) the prolongation of antigen
                          exposure to antigen-presenting cells by the
                          creation of a depot at the site of injection,
                          2) the activation of antigen presenting
                          cells, such as monocytes or macrophages, to
                          release cytokines that can promote T-cell
                          help for B cell and CTL response, 3) the
                          introduction of antigen into the MHC Class I
                          processing pathway. As a result, the adjuvant
                          may induce a more favorable antibody response
                          with high titers, which appear earlier in the
                          course of immunization and persist over time,
                          as well as increase memory responses and CD8+
                          MHC Class I-restricted CTL. [NIAID VEU 015]
                          [Ann NY Acad Sci 1995 May 31;754] [J Infect
                          Dis 1994 Nov;170(5)]
 DISEASES STUDIED/TREATED Primary HIV infection: as a vaccine adjuvant
                          for the enhancement of the immune response [J
                          Infect Dis 1994 Nov;170(5)] [NIAID VEU 015]
                          [NIAID VEU 005]
 DISEASES STUDIED/TREATED Used as an emulsifier system in conjunction
                          with other adjuvants such as MTP-PE [J Infect
                          Dis 1994 Nov;170(5)] [NIAID VEU 015] [NIAID
                          VEU 005]
 CLASSIFICATION CODE      Adjuvant [Ann NY Acad Sci 1995 May 31;754]
 CLASSIFICATION CODE      Immunostimulant [NIAID VEU 015]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: This emulsion consists of
                          0.5% polysorbate 80 and 0.5% sorbitan
                          trioleate. Squalene (5.0%), a metabolizable
                          lipid, constitutes the oil phase [NIAID VEU
                          015]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Emulsion [Int Conf AIDS
                          1992 Jul 19-24;8(1): (abstract no. MoB 0025)]
                          [NIAID VEU 015]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Vial with a fill volume of 0.65
                          ml and a withdrawable volume of 0.50 ml.
                          [NIAID VEU 015]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular injection.
                          [Int Conf AIDS 1993 Jun 6-11;9(1):(abstract
                          no. WS-B27-2)]
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Store refrigerated at
                          2-8 C. [NIAID VEU 015]
 MANUFACTURERS            The BIOCINE Company
 REFERENCES               Langenberg AG, Burke RL, Adair SF, Sekulovich
                          R, Tigges M, Dekker CL, Corey L. A
                          recombinant glycoprotein vaccine for herpes
                          simplex virus type 2: safety and
                          immunogenicity [corrected] [published erratum
                          appears in Ann Intern Med 1995 Sep
                          1;123(5):395]. Ann Intern Med 1995 Jun
                          15;122(12):889-98.
 REFERENCES               Ott G, Barchfeld GL, Chernoff D,
                          Radhakrishnan R, van Hoogevest P, Van Nest G.
                          MF59. Design and evaluation of a safe and
                          potent adjuvant for human vaccines. Pharm
                          Biotechnol. 1995;6:277-96.
 REFERENCES               Valensi JP, Carlson JR, Van Nest GA. Systemic
                          cytokine profiles in BALB/c mice immunized
                          with trivalent influenza vaccine containing
                          MF59 oil emulsion and other advanced
                          adjuvants. J Immunol 1994 Nov
                          1;153(9):4029-39.
 REFERENCES               McElrath MJ, Corey L, Clements ML, Belshe R,
                          Keefer M, Graham B, Fast P, Matthews T,
                          Duliege AM, Francis D. A phase II HIV vaccine
                          trial in seronegative subjects: safety,
                          immunogenicity, and future directions. Int
                          Conf AIDS. 1994 Aug 7-12;10(1):91 (abstract
                          no. 317A).
 REFERENCES               Kahn JO, Sinangil F, Baenziger J, Murcar N,
                          Wynne D, Coleman RL, Steimer KS, Dekker CL,
                          Chernoff D. Clinical and immunologic
                          responses to human immunodeficiency virus
                          (HIV) type 1SF2 gp120 subunit vaccine
                          combined with MF59 adjuvant with or without
                          muramyl tripeptide dipalmitoyl
                          phosphatidylethanolamine in non-HIV-infected
                          human volunteers. J Infect Dis. 1994
                          Nov;170(5):1288-91.
 REFERENCES               Kahn JO, Birx DL. Vaccines directed against
                          HIV: preventive and therapeutic strategies.
                          AIDS Clin Rev. 1993-94;213-238.
 REFERENCES               Kahn J, Chernoff D, Sinangil F, Baenziger J,
                          Murcar N, Steimer K. Phase I study of an
                          HIV-1 gp 120 vaccine combined with MF59 and
                          with dose escalation of MTP-PE, in
                          sero-negative adults. Int Conf AIDS. 1993 Jun
                          6-11;9(1):70 (abstract no. WS-B27-2).
 REFERENCES               Corey L, McElrath J, Keefer M, Paxton W,
                          Sposto R, Chernoff D. A phase I HIV-1 vaccine
                          trial in asymptomatic HIV-infected
                          individuals using Env 2-3 in MF-59 with or
                          without MTP-PE. Int Conf AIDS. 1993 Jun
                          6-11;9(1):494 (abstract no. PO-B28-2152).
 REFERENCES               Keefer M, Graham B, McElrath J, Matthews T,
                          Chernoff D, Dolin R. Phase I trial of an
                          HIV-1 vaccine candidate, Env 2-3, in
                          combination with MTP-PE/MF59. Int Conf AIDS.
                          1993 Jun 6-11;9(1):252 (abstract no.
                          PO-A29-0708).
 REFERENCES               Graham B, Keefer M, McElrath J, Matthews T,
                          Schwartz D, Gorse G, Sposto R, Chernoff D.
                          Phase I trial of native HIV-1SF-2 rgp120
                          candidate vaccine. Int Conf AIDS. 1993 Jun
                          6-11;9(1):250 (abstract no. PO-A29-0692).
 ENTRY MONTH              9306
 LAST REVISION DATE       960403
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
