      Document 0095
 DOCN  DRG0095
 UNIQUE IDENTIFIER        DRG-0152
 NAME OF SUBSTANCE        rgp120/HIV-1IIIB [AmFAR Tx Dir 1995;7(4)]
 SYNONYMS                 IIIB rgp120/HIV-1 [AmFAR Tx Dir 1995;7(4)]
 PROTOCOL ID NUMBERS      FDA 075A
 PROTOCOL ID NUMBERS      NIAID VEU 006
 PROTOCOL ID NUMBERS      NIAID VEU 009
 PROTOCOL ID NUMBERS      VEU 010
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: It has been theorized that
                          subunit vaccines consisting of HIV antigens
                          may stimulate humoral and lymphoproliferative
                          cell immune responses. One animal study
                          showed IIIB rgp120/HIV-1 protected two
                          chimpanzees from infection with a homologous
                          strain of cell-free HIV after three
                          inoculations with 300 micrograms of vaccine.
                          However, a similar study performed with
                          another recombinantly produced vaccine based
                          on gp120 from HIV strain IIIB showed the
                          vaccine did not protect chimpanzees from
                          infections with a homologous strain of HIV.
                          In human studies IIIB rgp120/HIV produced
                          significant increases in proliferative
                          responses to the gp120 antigens. [AmFAR Tx
                          Dir 1993;6(4)] [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)]
 SUBSTANCE INTERACTIONS   Interacts with corticosteroids or other known
                          immunosuppressive drugs, any experimental
                          agents, and antituberculous medications. [FDA
                          075A] [NIAID VEU 009]
 ADVERSE EFFECTS          No clinicallly significant adverse events
                          have been attributed to the vaccine. [Int
                          Conf AIDS 1993 Jun 6-11;9(1):(abstract no.
                          PO-B27-2137)]
 CONTRAINDICATIONS        Contraindicated in the presence of prior
                          history of clinically significant cardiac,
                          pulmonary, hepatic, renal or autoimmune
                          disease (other than HIV infection);
                          pregnancy; and breastfeeding. [AmFAR Tx Dir
                          April, 1991]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Vaccine preparation IIIB
                          rgp120/HIV is a genetically engineered form
                          of envelope glycoprotein gp120 derived from
                          HIV-1 strain IIIB [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: It is propagated in
                          mammalian cells [AmFAR Tx Dir 1995;7(4)]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular injection
                          (IM). [AmFAR Tx Dir April, 1991]
 MANUFACTURERS            Genentech Incorporated
 REFERENCES               Warner JF, Jolly D, Mento S, Galpin J,
                          Haubrich R, Merritt J. Retroviral vectors for
                          HIV immunotherapy. Ann N Y Acad Sci 1995 Nov
                          27;772:105-6.
 REFERENCES               Fast PE, Sawyer LA, Wescott SL. Clinical
                          considerations in vaccine trials with special
                          reference to candidate HIV vaccines. Pharm
                          Biotechnol 1995;6:97-134.
 REFERENCES               Schwartz DH, Gorse G, Clements ML, Belshe R,
                          Izu A, Duliege AM, Berman P, Twaddell T,
                          Stablein D, Sposto R, et al. Induction of
                          HIV-1-neutralising and syncytium-inhibiting
                          antibodies in uninfected recipients of
                          HIV-1IIIB rgp120 subunit vaccine. Lancet 1993
                          Jul 10;342(8863):69-73.
 REFERENCES               Allan JD, Conant M, Lavelle J, Mitsuyasu R,
                          Twaddell T, Kahn J. Safety and immunogenicity
                          of MN and IIB rgp 120/HIV-1 vaccines in HIV-1
                          infected subjects with CD4 counts > 500
                          cells/mm3. Int Conf AIDS 1993 Jun
                          6-11;9(1):491 (abstract no. PO-B27-2137).
 REFERENCES               Belshe R, Keefer M, Graham B, Matthews T,
                          Twaddell T, Fast P. Safety and immunogenicity
                          of HIV-1 (MN or combination MN/IIIB) rgp120
                          vaccines in low risk volunteers. The NIAID
                          AIDS Vaccine Evaluation Network. Int Conf
                          AIDS. 1993 Jun 6-11;9(1):70 (abstract no.
                          WS-27-1).
 REFERENCES               Hamilton BL, Byrn RA, Giorgi J, Izu AE. T
                          cell proliferation as a measure of the
                          immunogenicity of HIV/gp120 vaccines in
                          seropositive subjects. Int Conf AIDS. 1993
                          Jun 6-11;9(1):491 (abstract no. PO-B27-2136).
 REFERENCES               Schwartz D, Clements ML, Belshe R, Gorse G,
                          Izu A. Antibody responses to neutralizing
                          domains of gp120 in HIV(-) vaccinees boosted
                          with homologous or heterologous rgp120. The
                          NIAID AIDS Vaccine Evaluation Group. Int Conf
                          AIDS. 1993 Jun 6-11;9(1):249 (abstract no.
                          PO-A29-0690).
 REFERENCES               Clements ML, Belshe R, Duliege AM, Schwartz
                          D, Gorse G, Izu A, Ammann A. Safety and
                          immunogenicity of IIIB rgp120/HIV-1 vaccine
                          in seronegative volunteers. The
                          NIAID-sponsored AIDS Vaccine Clinical Trials
                          Network. Int Conf AIDS. 1992 Jul
                          19-24;8(1):Mo9 (abstract no. MoB 0026).
 REFERENCES               Rovinski B, Cao SX, James O, Sia C,
                          Zolla-Pazner S, Matthews T, Klein M.
                          Genetically engineered HIV-like particles
                          containing chimeric MN/LAI envelope
                          glycoproteins can induce cross-neutralizing
                          antibodies recognizing the IIIB and MN
                          isolates. Int Conf AIDS. 1992 Jul
                          19-24;8(1):We52 (abstract no. WeD 1041).
 ENTRY MONTH              9212
 LAST REVISION DATE       960307
 

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