      Document 0206
 DOCN  DRG0206
 UNIQUE IDENTIFIER        DRG-0041
 NAME OF SUBSTANCE        gp160 Vaccine (MicroGeneSys) [AmFAR Tx Dir
                          1993 April;6(3)]
 SYNONYMS                 HIV envelope protein gp160 [MeSH]
 SYNONYMS                 Human T-lymphotropic virus type III gp 160
                          antigens, recombinant vaccine, alum adsorbed
                          [USP DI 1995]
 SYNONYMS                 Glycoprotein 160 HIV [MeSH]
 SYNONYMS                 gp160 envelope protein, HIV [MeSH]
 SYNONYMS                 VaxSyn [AmFAR Tx Dir 1995];7(4)]
 SYNONYMS                 rgp160 [MeSH]
 SYNONYMS                 MicroGeneSys HIV-1 gp160 vaccine [MeSH]
 SYNONYMS                 VaxSyn HIV-1 (gp160) vaccine [MeSH]
 SYNONYMS                 VaxSyn HIV-1 (gp160) [MeSH]
 SYNONYMS                 Recombinant gp160 [AmFAR Tx Dir 1995;7(4)]
 PROTOCOL ID NUMBERS      NIAID ACTG 137
 PROTOCOL ID NUMBERS      NIAID ACTG 148
 PROTOCOL ID NUMBERS      NIAID 87 I-114
 PROTOCOL ID NUMBERS      FDA 063A
 PROTOCOL ID NUMBERS      NIAID VEU 002
 PROTOCOL ID NUMBERS      NIAID VEU 002A
 PROTOCOL ID NUMBERS      NIAID VEU 002B
 PROTOCOL ID NUMBERS      NIAID 90 I-5
 PROTOCOL ID NUMBERS      NIAID VEU 010
 PROTOCOL ID NUMBERS      NIAID VEU 008
 PROTOCOL ID NUMBERS      NIAID VEU 003
 PROTOCOL ID NUMBERS      NIAID VEU 003A
 PROTOCOL ID NUMBERS      NIAID VEU 003B
 PROTOCOL ID NUMBERS      NIAID ACTG 221
 PROTOCOL ID NUMBERS      NIAID ACTG 218
 PROTOCOL ID NUMBERS      NIAID ACTG 234
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: It is theorized that subunit
                          vaccines consisting of HIV antigens may
                          stimulate humoral and lymphoproliferative
                          cellular immune responses. Some investigators
                          have hypothesized that since the VaxSyn
                          molecule is substantially denatured it may
                          stimulate less relevant antibodies than
                          recombinant vaccine products which mimic the
                          3-D structure of native viral particles.
                          Current experiments show VaxSyn can cause the
                          development of significant
                          lymphoproliferative responses, enhanced
                          cytotoxic activity against targets bearing
                          gp160, and increased levels of antibodies to
                          gp 160. [AmFAR Tx Dir 1995;7(4)] [NIAID VEU
                          008]
 DISEASES STUDIED/TREATED Primary HIV infection [AmFAR Tx Dir
                          1995;7(4)]
 CLASSIFICATION CODE      Vaccine [AmFAR Tx Dir 1995;7(4)]
 ADVERSE EFFECTS          Intramuscular dosages forms are well
                          tolerated, local reactions are common,
                          including tenderness and indurations at the
                          injection site. Mild fever, myalgia or
                          fatigue may occur. Intradermal injections
                          produced subcutaneous nodules, prolonged skin
                          discoloration and resulted in occasional
                          purulent drainage and local pruritis. Nausea
                          and headache were also reported. [AmFAR Tx
                          Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Molecularly-cloned,
                          denatured envelope glycoprotein derived from
                          the LAV strain of HIV-1 [AmFAR Tx Dir
                          1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: VaxSyn is propagated in
                          insect cells and adsorbed to an alum
                          adjuvant. The preparation is expressed in
                          baculovirus [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 160,000 daltons [NIAID VEU
                          008]
 CHEMICAL/PHYSICAL DATA   MOLECULAR COMPOSITION: Protein structure
                          representing the entire envelope precursor
                          protein, gp160 [NIAID 87 I-114]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Formulated powder
                          [NIAID VEU 008]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 1-ml vials containing 320 mcg/ml
                          HIV-1 gp160 adsorbed onto 0.5 mg aluminum
                          phosphate. [NIAID VEU 008]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY:  Intramuscular injection.
                          [AmFAR Tx Dir 1995;7(4)]
 SUBSTANCE DELIVERY DATA  STORAGE: Store at 2-8 C. Use within 24 hours
                          after opening sealed vials. Do not freeze.
                          [NIAID VEU 008]
 MANUFACTURERS            MicroGeneSys Incorporated
 REFERENCES               Gorse GJ, Schwartz DH, Graham BS, Matthews
                          TJ, Stablein DM, Frey SE, Belshe RB, Clements
                          ML, Wright PF, Eibl M, et al. HIV-1
                          recombinant gp160 vaccine given in
                          accelerated dose schedules. Clin Exp Immunol.
                          1994 Nov;98(2):178-84.
 REFERENCES               Lundholm P, Wahren M, Sandstrom E, Volvovitz
                          F, Wahren B. Changes in autoreactivity during
                          HIV rgp160 vaccination. Int Conf AIDS. 1994
                          Aug 7-12;10(2):90 (abstract no. PA0239).
 REFERENCES               Belshe RB, Clements ML, Dolin R, Graham BS,
                          McElrath J, Gorse GJ, Schwartz D, Keefer MC,
                          Wright P, Corey L, et al. Safety and
                          immunogenicity of a fully glycosylated
                          recombinant gp160 human immunodeficiency
                          virus type 1 vaccine in subjects at low risk
                          of infection. J Infect Dis. 1993
                          Dec;168(6):1387-95.
 REFERENCES               Kovacs JA, Vasudevachari MB, Easter M, Davey
                          RT, Falloon J, Polis MA, Metcalf JA, Salzman
                          N, Baseler M, Smith GE, et al. Induction of
                          humoral and cell-mediated anti-human
                          immunodeficiency virus (HIV) responses in HIV
                          sero-negative volunteers by immunization with
                          recombinant gp160. J Clin Invest. 1993
                          Aug;92(2):919-28.
 REFERENCES               Tsoukas CM, Sampalis J, Gold P, Wainberg M,
                          Volvovitz F, Smith G. Long term use of
                          recombinant gp160 as a therapeutic vaccine in
                          asymptomatic HIV infection. Int Conf AIDS.
                          1993 Jun 6-11;9(1):491 (abstract no.
                          PO-B27-2134).
 REFERENCES               Blick G, Crook S, Buchanan S, Pelke I, Smith
                          G, Volvovitz F. A phase I/II trial evaluating
                          the combination use of recombinant GP160
                          (VaxSyn) and P24 vaccines vs. GP160 and
                          placebo by intradermal injection in
                          HIV-seropositive individuals regardless of
                          initial CD4+ cell counts. Int Conf AIDS. 1993
                          Jun 6-11;9(1):490 (abstract no. PO-B27-2128).
 REFERENCES               Bratt G, Eriksson L, Sandstrom E, Gilljam G,
                          Hinkula J, Wahren B. A study of a GP160
                          vaccine in healthy HIV-carriers with and
                          without zidovudine. Int Conf AIDS. 1992 Jul
                          19-24;8(2):B93 (abstract no. PoB 3036).
 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).
 REFERENCES               Tsoukas C, Sampalis J, Gold P, O'Shaughnessy
                          M, Wainberg M, Smith G, Volvovitz F. Specific
                          active immunotherapy in asymptomatic HIV
                          disease using recombinant gp160. Int Conf
                          AIDS. 1992 Jul 19-24;8(1):Tu39 (abstract no.
                          TuB 0560).
 REFERENCES               Picard O, Achour A, Bernard J, Halbreich A,
                          Bizzini B, Boyer V, Desgranges C, Bertho JM,
                          Lachgar A, Polliotti B, et al. A 2-year
                          follow-up of an anti-HIV immune reaction in
                          HIV-1 gp160-immunized healthy seronegative
                          humans: evidence for persistent cell-mediated
                          immunity. J Acquire Immune Defic Syndr.
                          1992;5(6): 539-46.
 ENTRY MONTH              8909
 LAST REVISION DATE       960310
 

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