      Document 0072
 DOCN  DRG0072
 UNIQUE IDENTIFIER        DRG-0175
 NAME OF SUBSTANCE        Syntex adjuvant formulation [Vaccine
                          1993;11(3)]
 SYNONYMS                 SAF/2 [NIAID VEU 015]
 PROTOCOL ID NUMBERS      NIAID VEU 015
 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. Vaccines using
                          SAF have protected guinea pigs against
                          genital herpes simplex virus infections and
                          subhuman primates against Epstein-Barr virus
                          and simian immunodeficiency virus infections.
                          [NIAID VEU 015] [Semin Immunol 1990 Sep;2(5)]
 DISEASES STUDIED/TREATED Primary HIV infection: as a vaccine adjuvant
                          for the enhancement of the immune response
                          [NIAID VEU 015]
 CLASSIFICATION CODE      Adjuvant [Semim Immunol 1990 Sep;2(5)]
 CLASSIFICATION CODE      Immunostimulant [NIAID VEU 015]
 ADVERSE EFFECTS          Adverse effects include discomfort at the
                          site of injection; mild acute elevations in
                          white blood count, CPK and sedimentation rate
                          have been observed. [NIAID VEU 015]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: An emulsion consisting of
                          squalene, Pluronic L121 block polymer, and
                          Tween 80 in phosphate-buffered saline [NIAID
                          VEU 015]
 CHEMICAL/PHYSICAL DATA   PHYSICAL COMMENT: Properties of SAF are
                          compared with those of other adjuvants,
                          including lipopolysaccharide analogs,
                          ISCOM's, and liposomes [Semin Immunol 1990
                          Sep;2(5)]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 0.6 ml vial. [NIAID VEU 015]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular injection.
                          [NIAID VEU 015]
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Store refrigerated at
                          2-8 C. [NIAID VEU 015]
 MANUFACTURERS            The BIOCINE Company
 REFERENCES               Robuccio JA, Griffith JW, Chroscinski EA,
                          Cross PJ, Light TE, Lang CM. Comparison  of
                          the effects of five adjuvants on the antibody
                          response to influenza virus antigen in guinea
                          pigs. Lab Anim Sci 1995 Aug;45(4):420-6.
 REFERENCES               Houston L, Moncla BJ, Page R, Engel D.
                          Response of guinea pigs to a vaccine
                          containing a new adjuvant (SAF) and
                          gram-negative bacteria. Lab Anim Sci 1995
                          Feb;45(1):59-66.
 REFERENCES               Perraut R, Chouteau P, Bourreau E, Bonnemain
                          B, Garraud O. Assays for adjuvanticity of new
                          formulations and of carrier proteins for
                          inducing antibody responses to selected
                          immunogens in the squirrel monkey Saimiri
                          sciureus. Immunol Cell Biol. 1994
                          Apr;72(2):169-75.
 REFERENCES               Byars NE, Fraser-Smith EB, Pecyk RA, Welch M,
                          Nakano G, Burke RL, Hayward AR, Allison AC.
                          Vaccinating guinea pigs with recombinant
                          glycoprotein D of herpes simplex virus in an
                          efficacious adjuvant formulation elicits
                          protection against vaginal infection.
                          Vaccine. 1994;12(3):200-9.
 REFERENCES               Allison AC. Adjuvants and immune enhancement.
                          Int J Technol Assess Health Care. 1994
                          Winter;10(1):107-20.
 REFERENCES               Ohkawa S, Wilson LA, Larosa G, Javaherian K,
                          Martin LN, Murphey-Corb M. Immune responses
                          induced by prototype vaccines for AIDS in
                          rhesus monkeys. AIDS Res Hum Retroviruses
                          1994 Jan;10(10:27-38.
 REFERENCES               Gupta RK, Relyveld EH, Lindblad EB, Bizzini
                          B, Ben-Efraim S, Gupta CK. Adjuvants-- a
                          balance between toxicity and adjuvanticity.
                          Vaccine. 1993;11(3):293-306.
 REFERENCES               McBride BW, Corthals G, Rud E, Kent K,
                          Webster S, Cook N, Cranage MP. Comparison of
                          serum antibody reactivities to a
                          conformational and to linear antigenic sites
                          in the external envelope glycoprotein of
                          simian immunodeficiency virus (SIVmac)
                          induced by infection and vaccination. J Gen
                          Virol. 1993 Jun;74 (Pt 6):1033-41.
 REFERENCES               Allison AC, Byars NE. Syntex adjuvant
                          formulation. Res Immunol. 1992
                          Jun;143(5):519-25.
 REFERENCES               Ewasyshyn M, Caplan B, Bonneau AM, Scollard
                          N, Graham S, Usman S, Klein M. Comparative
                          analysis of immunostimulatory properties of
                          different adjuvants on the immunogenicity of
                          a prototype parainfluenza virus type 3
                          subunit vaccine. Vaccine. 1992;10(6):412-20.
 ENTRY MONTH              9306
 LAST REVISION DATE       960403
 

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