      Document 0075
 DOCN  DRG0075
 UNIQUE IDENTIFIER        DRG-0172
 NAME OF SUBSTANCE        Aluminum hydroxide [USAN 1996]
 REGISTRY NUMBER          21645-51-2
 STANDARD CHEMICAL NAME   Aluminum hydroxide [USAN 1996]
 SYNONYMS                 Aluminum hydrate [Merck Index 1989]
 SYNONYMS                 Aluminum trihydrate [Merck Index 1989]
 SYNONYMS                 Hydrated alumina [Merck Index 1989]
 SYNONYMS                 Alhydrogel [NIAID VEU 015]
 SYNONYMS                 Superfos [NIAID VEU 015]
 SYNONYMS                 Amphojel [USAN 1996]
 SYNONYMS                 Dialume [USAN 1996]
 SYNONYMS                 Creamalin [Merck Index 1989]
 SYNONYMS                 Cremorin [Merck Index 1989]
 SYNONYMS                 ALternaGEL [Merck Index 1989]
 SYNONYMS                 Al-U-Creme [Merck Index 1989]
 SYNONYMS                 Alucol [Merck Index 1989]
 SYNONYMS                 Hycolal [Merck Index 1989]
 SYNONYMS                 Hydrolum [Merck Index 1989]
 SYNONYMS                 Merlum [Merck Index 1989]
 SYNONYMS                 Aludrox [Merck Index 1989]
 SYNONYMS                 Alkagel [Merck Index 1989]
 SYNONYMS                 Collumol [Merck Index 1989]
 SYNONYMS                 Aldrox [Merck Index 1989]
 SYNONYMS                 Aludyal [Merck Index 1989]
 SYNONYMS                 Pepsamar [Merck Index 1989]
 SYNONYMS                 Fluagel [Merck Index 1989]
 SYNONYMS                 Gelumina [Merck Index 1989]
 SYNONYMS                 Uracid [Merck Index 1989]
 SYNONYMS                 Vanogel [Merck Index 1989]
 SYNONYMS                 Alumigel [CHEMLINE]
 PROTOCOL ID NUMBERS      NIAID VEU 015
 PROTOCOL ID NUMBERS      NIAID VEU 016
 PROTOCOL ID NUMBERS      NIAID ACTG 214
 PROTOCOL ID NUMBERS      NIAID VEU 016A
 PROTOCOL ID NUMBERS      NIAID VEU 019
 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]
 DISEASES STUDIED/TREATED Primary HIV infection: as a vaccine adjuvant
                          for the enhancement of the immune response
                          [NIAID VEU 015]
 CLASSIFICATION CODE      Adjuvant [Merck Index 1989]
 CLASSIFICATION CODE      Immunostimulant [NIAID VEU 015]
 OTHER MAJOR USES         Alum has been used as an adjuvant since the
                          1920's and is the only adjuvant approved by
                          the FDA for use in human vaccines; aluminum
                          hydroxide is an antacid and a
                          antihyperphosphatemic [USAN 1996] [Merck
                          Index 1989] [NIAID VEU 015]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Aluminum salt (alum) [NIAID
                          VEU 015]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White, bulky, amorphous
                          powder [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   MOLECULAR FORMULA: Al(OH)3 [USAN 1996]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 78.00 [USAN 1996]
 CHEMICAL/PHYSICAL DATA   ELEMENTAL COMP.: Al34.58%, H3.88%, O61.54%
                          [Merck Index 1989]
 CHEMICAL/PHYSICAL DATA   SOLUBILITY: Practically insoluble in water;
                          soluble in alkaline aqueous solution, HCl,
                          H2SO4, and other strong acids [Merck Index
                          1989]
 CHEMICAL/PHYSICAL DATA   STABILITY: Forms gels on prolonged contact
                          with water. Absorbs acids and CO2 [Merck
                          Index 1989]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Aluminum hydroxide (2mg) in
                          water (q.s. to 1 ml). [NIAID VEU 015]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular injection.
                          [NIAID VEU 015]
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Store at 4 C. [NIAID
                          VEU 015]
 REFERENCES               Vogel FR. The role of adjuvants in retroviral
                          vaccines. Int J Immunopharmacol; VOL 17, ISS
                          2, 1995, P85-90 (REF: 43).
 REFERENCES               Vogel FR. Immunologic adjuvants for modern
                          vaccine formulations. Ann N Y Acad Sci 1995
                          May 31;754:153-60.
 REFERENCES               Stieneker F, Kersten G, van Bloois L,
                          Crommelin DJ, Hem SL, Lower J, Kreuter J.
                          Comparison of 24 different adjuvants for
                          inactivated HIV-2 split whole virus as
                          antigen in mice. Induction of titres of
                          binding antibodies and toxicity of the
                          formulations. Vaccine; VOL 13, ISS 1, 1995,
                          P45-53.
 REFERENCES               Men Y, Thomasin C, Merkle HP, Gander B,
                          Corradin G. A single administration of
                          tetanus toxoid in biodegradable microspheres
                          elicits T cell and antibody responses similar
                          or superior to those obtained with aluminum
                          hydroxide. Vaccine 1995 May;13(7):683-9.
 REFERENCES               Ma J, Bulger PA, Davis DR, Perilli-Palmer B,
                          Bedore DA, Kensil CR, Young EM, Hung CH,
                          Seals JR, Pavia CS, et al. Impact of the
                          saponin adjuvant QS-21 and aluminium
                          hydroxide on the immunogenicity of
                          recombinant OspA and OspB of Borrelia
                          burgdorferi. Vaccine 1994 Aug;12(10):925-32.
 REFERENCES               Goto N, Kato H, Maeyama J, Eto K, Yoshihara
                          S. Studies on the toxicities of aluminium
                          hydroxide and calcium phosphate as
                          immunological adjuvants for vaccines [see
                          comments]. Vaccine; VOL 11, ISS 9, 1993,
                          P914-8.
 REFERENCES               Stahl-Hennig C, Voss G, Nick S, Petry H,
                          Fuchs D, Wachter H, Coulibaly C, Luke W,
                          Hunsmann G. Immunization with
                          tween-ether-treated HIV adsorbed onto
                          aluminum hydroxide protects monkeys against
                          experimental HIV infection. Virology. 1992
                          Feb;186(2):588-96.
 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               Nicklas W. Aluminum salts. Res Immunol. 1992
                          Jun;143(5):489-94.
 REFERENCES               Bomford R, Stapleton M, Winsor S, McKnight A,
                          Andronova T. The control of the antibody
                          isotype response to recombinant human
                          immunodeficiency virus gp120 antigen by
                          adjuvants. AIDS Res Hum Retroviruses. 1992
                          Oct;8(1):1765-71.
 ENTRY MONTH              9306
 LAST REVISION DATE       960405
 

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