      Document 0085
 DOCN  DRG0085
 UNIQUE IDENTIFIER        DRG-0162
 NAME OF SUBSTANCE        gp160 Vaccine (Immuno-AG) [NIAID ACTG 205]
 SYNONYMS                 HIV envelope protein gp160 [MeSH]
 SYNONYMS                 Glycoprotein 160 HIV [MeSH]
 SYNONYMS                 gp160 envelope protein, HIV [MeSH]
 SYNONYMS                 IIIB rpg160 [Immuno U.S.] [AmFAR Tx Dir
                          1995;7(4)]
 SYNONYMS                 VaxSyn [MicroGene Sys] [AmFAR Tx Dir
                          1995;7(4)]
 PROTOCOL ID NUMBERS      NIAID ACTG 205
 PROTOCOL ID NUMBERS      NIAID VEU 004
 PROTOCOL ID NUMBERS      NIAID VEU 004A
 PROTOCOL ID NUMBERS      NIAID VEU 004B
 PROTOCOL ID NUMBERS      NIAID ACTG 221
 PROTOCOL ID NUMBERS      NIAID VEU 013B
 PROTOCOL ID NUMBERS      NIAID VEU 010
 PROTOCOL ID NUMBERS      NIAID VUE 013A
 PROTOCOL ID NUMBERS      NIAID ACTG 246
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Subunit vaccines consisting
                          of HIV antigens may stimulate humoral and
                          lymphoproliferative cellular immune
                          responses. Data from non-HIV infected people
                          receiving experimental vaccines indicates
                          that the induced antibodies are not effective
                          at neutralizing primary (clinical) HIV
                          isolates. Implications of these data for
                          therapeutic vaccine trials are not clear.
                          Conformational similarity of rpg160 to native
                          gp160 may have positve implications for
                          blockage of primary infections with diverse
                          HIV-1 strains. Since the VaxSyn molecule is
                          substantially denatured, it may stimulate
                          less relevant antibodies than recombinant
                          vaccine products which mimic the
                          three-dimensional structure of native viral
                          particles. Immuno-AG gp160 vaccine is
                          obtained by using a recombinant vaccinia
                          virus/bacteriophage T7 hybrid system to
                          express the HIV env gene in mammalian cells.
                          One vaccinia recombinant contains the
                          bacteriophage T7 polymerase gene under the
                          direction of the vaccinia virus P7.5
                          promoter. Vero cells are co-infected with
                          this recombinant and another vaccinia
                          recombinant containing the HIV gp160 env gene
                          under the direction of the T7 promoter. The
                          rgp160 is purified from infected Vero cells
                          following extraction, lentil-lectin
                          chromatography, immune affinity
                          chromatography, ion-exchange chromatography,
                          a second lentil-lectin chromatography, and
                          dialysis. Research shows that rgp160 is well
                          tolerated and that repeated injections of
                          rgp160 can induce specific T cell
                          proliferation responses. [Int Conf AIDS 1993
                          Jun 6-11;9(1):(abstract no. PO-A28-0668)]
                          [NIAID ACTG 205] [AmFAR Tx Dir 1995;7(4)]
 DISEASES STUDIED/TREATED HIV infection [AmFAR Tx Dir 1995;7(4)]
 CLASSIFICATION CODE      Vaccine [AmFAR Tx Dir 1995;7(4)]
 ADVERSE EFFECTS          VaxSyn (recombinant gp60) has been well
                          tolerated when given IM. Local reactions are
                          common including tenderness and induration at
                          the injection site. Mild fever, myalgia or
                          fatigue may accompany local reactions.
                          Interdermal administration results in
                          subcutaneous nodule formation, prolonged skin
                          discoloration, occasional purulent drainage
                          and local pruritis. Other side effects
                          include headaches and nausea. [AmFAR Tx Dir
                          1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: rgp160 is a recombinant
                          form of purified envelope glycoprotein gp160
                          derived from either the IIIB or MN strain of
                          HIV-1 [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: It is fully glycosylated,
                          with a 3-dimensional shape approximately
                          identical to gp160 [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Formulated powder
                          [NIAID ACTG 205]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Liquid. [NIAID ACTG 205]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular. [AmFAR Tx
                          Dir 1995;7(4)]
 SUBSTANCE DELIVERY DATA  STORAGE: Store at 2-8 C (35-46 F). [NIAID
                          ACTG 205]
 MANUFACTURERS            Immuno-US Incorporated
 REFERENCES               Loomis LD, Deal CD, Kersey KS, Burke DS,
                          Redfield RR, Birx DL. Humoral responses to
                          linear epitopes on the HIV-1 envelope in
                          seropositive volunteers after vaccine therapy
                          with rgp160. J Acquir Immune Defic Syndr Hum
                          Retrovirol. 1995 Sep 1;10(1):13-26.
 REFERENCES               Keefer MC, Graham BS, Belshe RB, Schwartz D,
                          Corey L, Bolognesi DP, Stablein DM,
                          Montefiori DC, McElrath MJ, Clements ML, et
                          al. Studies of high doses of a human
                          immunodeficiency virus type 1 recombinant
                          glycoprotein 160 candidate vaccine in HIV
                          type 1-seronegative humans. The AIDS Vaccine
                          Clinical Trials Network. AIDS Res Hum
                          Retroviruses. 1994 Dec;10(12):1713-23.
 REFERENCES               Bristow RG, Douglas AR, Skehel JJ, Daniels
                          RS. Analysis of murine antibody responses to
                          baculovirus-expressed human immunodeficiency
                          virus type 1 envelope glycoproteins. J Gen
                          Virol. 1994 Aug;75 (Pt 8):2089-95.
 REFERENCES               Aiuti F, Pontesilli O, Guerra E, Ricci G,
                          Varani AR, Carlesimo M, Scala E, Mollicone B,
                          Giovannetti A, Pandolfi F, et al.
                          Immunotherapy with rgp160 (VaxSyn), and AZT,
                          in asymptomatic HIV-infected individuals. Int
                          Conf AIDS. 1994 Aug 7-12;10(1):227 (abstract
                          no. PB0337).
 REFERENCES               DeMaria A, Coady W, Cohen C, Epstein P,
                          Kunches L, Mayer K, Werner B. Therapeutic
                          gp160 vaccine (VaxSyn) in adults with CD4
                          counts < 400/mm3. Int Conf AIDS. 1994 Aug
                          7-12;10(1):219 (abstract no. PBO307).
 REFERENCES               Montefiori DC, Graham BS, Zhou J, Zhou J,
                          Bucco RA, Schwartz DH, Cavacini LA, Posner
                          MR. V3-specific neutralizing antibodies in
                          sera from HIV-1 gp160-immunized volunteers
                          block virus fusion and act synergistically
                          with human monoclonal antibody to the
                          conformation-dependent CD4 binding site of
                          gp120. NIH-NIAID AIDS Vaccine Clinical Trials
                          Network. J Clin Invest. 1993 Aug;92(2):840-7.
 REFERENCES               Funkhouser A, Clements ML, Slome S, Clayman
                          B, Viscidi R. Antibodies to recombinant gp160
                          in mucosal secretions and sera of persons
                          infected with HIV-1 and seronegative vaccine
                          recipients. AIDS Res Hum Retroviruses. 1993
                          Jul;9(7):627-32.
 REFERENCES               Schwartz D, Clements ML, Belshe R, Gorse G,
                          et al. Interim results of rgp160 vaccine
                          trial in HIV+ volunteers. Int Conf AIDS. 1993
                          Jun 6-11;9(1):246 (abstract no. PO-A28-0668).
 REFERENCES               Schwartz D, Graham B, Bolognesi D, Belshe R,
                          Eibl M. Safety and immunogenicity of rgp160
                          in accelerated dose schedules. Int Conf AIDS.
                          1993 Jun 6-11;91):70 (abstract no. WS-B27-4).
 REFERENCES               Keefer M, Belshe R, Clements M, Graham B,
                          Corey L, Bolognesi D, Stablein D, Koff W,
                          Montefiori D, Smith G, et al. Safety and
                          immunogenicity of a baculovirus-derived HIV-1
                          IIIB  recombinant gp160 vaccine (Vaxsyn). Int
                          Conf AIDS. 1992 Jul 19-24;8(2):A41 (abstract
                          no. PoA 2228).
 ENTRY MONTH              9302
 LAST REVISION DATE       960310
 

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