      Document 0069
 DOCN  DRG0069
 UNIQUE IDENTIFIER        DRG-0178
 NAME OF SUBSTANCE        QS-21 [Ann NY Acad Sci 1995 May 31;754]
 SYNONYMS                 QS21 [NIAID VEU 015]
 PROTOCOL ID NUMBERS      NIAID VEU 016
 PROTOCOL ID NUMBERS      NIAID VEU 016A
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: The potential and desired
                          effects of this adjuvant may include the
                          following: an increase in antibody responses
                          directed to neutralizing epitopes, a
                          reduction in the time interval needed to
                          achieve high neutralizing antibody titers, an
                          increase in the duration of the immune
                          responses, the induction of CD8+
                          MHC-restricted CTL, and a decrease in the
                          amount of immunogen needed in the vaccine
                          preparation. The saponin adjuvant, QS-21, has
                          been extensively tested in experimental
                          vaccine formulations in animals and in one
                          human trial, and results to date indicate
                          that this adjuvant may offer several of the
                          above desired effects in combination with
                          with a subunit HIV-1 envelope vaccine. [NIAID
                          VEU 016] [AIDS Res Hum Retroviruses 1995
                          Feb;11(2)] [J of Immunol 1992 Mar 1;158(4)]
 DISEASES STUDIED/TREATED Primary HIV infection: as a vaccine adjuvant
                          for the enhancement of the immune response
                          [NIAID VEU 016]
 CLASSIFICATION CODE      Adjuvant [AIDS Res Hum Retroviruses 1995
                          Feb;11(2)]
 CLASSIFICATION CODE      Immunostimulant [NIAID VEU 015]
 ADVERSE EFFECTS          Adverse effects include tenderness at the
                          site of intramuscular injection and mild
                          flu-like symptoms. [NIAID VEU 016]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: A nontoxic saponin derived
                          from the soapbark tree Quillaja saponaria
                          [NIAID VEU 016] [AIDS Res Hum Retroviruses
                          1992 Aug;8(8)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The molecule contains 8
                          monosaccharides, 2 fatty acids and a
                          triterpene aldehyde (> 10 EU/mg), at C4
                          [NIAID VEU 016] [AIDS Res Hum Retroviruses
                          1992 Aug;8(8)]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 1990 kD [NIAID VEU 016]
 CHEMICAL/PHYSICAL DATA   PHYSICAL COMMENT: The amphipathic molecule
                          forms micelles at a concentration of 35 mcM
                          at pH 7 [NIAID VEU 016]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 3 ml vial containing 0.5 mg/ml
                          QS-21, 20 mM succinate pH 5.5, and 120 mM
                          NaCl. [NIAID VEU 016]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular injection.
                          [NIAID VEU 016]
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Refrigerate at 2-8 C.
                          [NIAID VEU 016]
 MANUFACTURERS            Genentech, Incorporated
 REFERENCES               Coughlin RT, Fish D, Mather TN, Ma J, Pavia
                          C, Bulger P. Protection of dogs from Lyme
                          disease with a vaccine containing outer
                          surface protein (Osp) A, OspB, and the
                          saponin adjuvant QS21. J Infect Dis 1995
                          Apr;171(4):1049-52.
 REFERENCES               Hancock GE, Speelman DJ, Frenchick PJ,
                          Mineo-Kuhn MM, Baggs RB, Hahn DJ. Formulation
                          of the purified fusion protein of respiratory
                          responses in Balb/c mice that are similar to
                          those generated by experimental infection.
                          Vaccine 1995 Mar;13(4):391-400.
 REFERENCES               Powell MF, Eastman DJ, Lim A, Lucas C,
                          Peterson M, Vennari J, Weissburg RP, Wrin T,
                          Kensil CR, Newman MJ, et al. Effect of
                          adjuvants on immunogenicity of MN recombinant
                          glycoprotein 120 in guinea pigs. AIDS Res Hum
                          Retroviruses 1995 Feb;11(2):203-9.
 REFERENCES               Britt W, Fay J, Seals J, Kensil C.
                          Formulation of an immunogenic human
                          cytomegalovirus vaccine: responses in mice. J
                          Infect Dis 1995 Jan;171(1):18-25.
 REFERENCES               Kensil CR, Wu JY, Soltysik S. Structural and
                          immunological characterization of the vaccine
                          adjuvant QS-21. Pharm Biotechnol
                          1995;6:525-41.
 REFERENCES               Cleland JL, Powell MF, Lim A, Barron L,
                          Berman PW, Eastman DJ, Nunberg JH, Wrin T,
                          Vennari JC. Development of a single-shot
                          subnit vaccine for HIV-1. AIDS Res Hum
                          Retroviruses. 1994;10 Suppl 2:S21-6.
 REFERENCES               Powel MF, Cleland JL, Eastman DJ, Lim A,
                          Newman MJ, Nunberg JH, Weissburg RP, Vennari
                          JC, Wrin T, Berman PW. Immunogenicity and
                          HIV-1 virus neutralization of MN recombinant
                          glycoprotien 120/HIV-1 QS21 vaccine in
                          baboons. AIDS Res Hum Retroviruses 1994;10
                          Suppl 2:S105-8.
 REFERENCES               Livingston PO, Adluri S, Helling F, Yao TJ,
                          Kensil CR, Newman MJ, Marciani D. Phase 1
                          trial of immunological adjuvant QS-21 with a
                          GM2 ganlioside-keyhole limpet haemocyanin
                          conjugate vaccine in patients with malignant
                          melanoma. Vaccine 1994 Nov;12(14):1275-80.
 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               Cleland JL, Powell MF, Lim A, Barron L,
                          Berman PW, Nunberg JH, Murthy KK. Controlled
                          release subunit vaccine for HIV-1. Int Conf
                          AIDS. 1994 Aug 7-12;10(2):119 (abstract no.
                          PAO358).
 ENTRY MONTH              9306
 LAST REVISION DATE       960403
 

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