      Document 0094
 DOCN  DRG0094
 UNIQUE IDENTIFIER        DRG-0153
 NAME OF SUBSTANCE        rgp120/HIV-1MN [AmFAR Tx Dir 1995;7(4)]
 SYNONYMS                 MN rgp120/HIV-1 [AmFAR Tx Dir 1995;7(4)]
 PROTOCOL ID NUMBERS      NIAID VEU 201
 PROTOCOL ID NUMBERS      NIAID VEU 009
 PROTOCOL ID NUMBERS      NIAID ACTG 209
 PROTOCOL ID NUMBERS      NIAID ACTG 218
 PROTOCOL ID NUMBERS      NIAID ACTG 214
 PROTOCOL ID NUMBERS      NIAID ACTG 230
 PROTOCOL ID NUMBERS      NIAID VEU 016A
 PROTOCOL ID NUMBERS      NIAID ACTG 235
 PROTOCOL ID NUMBERS      NAID VEU 006X
 PROTOCOL ID NUMBERS      NIAID VEU 010
 PROTOCOL ID NUMBERS      NIAID VEU 016
 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. MN rgp120/HIV-1 was
                          compared in preclinical studies with IIIB
                          rgp120/HIV-1 to assess differences in fusion
                          inhibition of rgp120 to recombinant CD4,
                          reactivity with the principal neutralizing
                          determinant (PND) of rgp120 and ability to
                          neutralize various clinical isolates of
                          HIV-1. The two products stimulated roughly
                          approximate levels of antibodies to gp120.
                          According to the manufacturer, the vaccine
                          based on MN was capable of reacting with the
                          PND of five diverse isolates while the IIIB
                          vaccine only reacted with the PND of the IIIB
                          strain of HIV-1. Single doses of MN
                          rgp120/HIV-1 up to 300 micrograms have been
                          administered safely to animals. [AmFAR Tx Dir
                          1993;6(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.
                          [NIAID VEU 009]
 ADVERSE EFFECTS          No clinically 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: MN rgp120/HIV-1 is a
                          genetically engineered form of envelope
                          glycoprotein gp120 derived from HIV-1 strain
                          MN [AmFAR Tx Dir 1993;6(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The HIV-1 strain MN is
                          highly representative of strains commonly
                          found in North America [AmFAR Tx Dir
                          1993;6(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The principal neutralizing
                          determinant (PND) of the MN strain is found
                          in approximately 60% of isolates in the
                          United States whereas the PND of strain IIIB
                          is found only in 5% of isolates in the U.S.
                          [AmFAR Tx Dir 1993;6(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: MN rgp120/HIV-1 is
                          propagated in a mammalian cell line [AmFAR Tx
                          Dir 1993;6(4)]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular (IM)
                          injection. [AmFAR Tx Dir April, 1991]
 MANUFACTURERS            Genentech Inc
 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;772:105-16.
 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               Yang E, Gorse G, Belshe R, Berman P. Salivary
                          antibody response to HIV-1 recombinant gp120
                          (rgp120) vaccine. Natl Conf Hum Retroviruses
                          Relat Infect (2nd). 1995 Jan 29-Feb 2;:151.
 REFERENCES               Lambert JS, McNamara J, Katz S, Livingston R,
                          Fenton T, Geheb H, Duliege AM, Francis D,
                          Volvowitz F, Hawkins E, et al. Safety and
                          immunogenicity of recombinant envelope HIV
                          vaccines in asymptomatic HIV infected
                          children. Natl Conf Hum Retroviruses Relat
                          Infect (2nd). 1995 Jan 29-Feb 2;:151.
 REFERENCES               Francis DP, Berman P, Gregory T. MNrgp120
                          vaccine to test or not to test. That is the
                          question. Natl Conf Hum Retroviruses Relat
                          Infect (2nd). 1995 Jan 29-Feb 2;:92.
 REFERENCES               McElrath MJ, Corey L, Clements ML, Belshe R,
                          Keefer M, Graham B, Fast P, Matthews T,
                          Duliege AM, Francis D. A phase II HIV vaccine
                          trial in seronegative subjects: safety,
                          immunogenicity, and future directions. Int
                          Conf AIDS. 1994 Aug 7-12;10(1):91 (abstract
                          no. 317A).
 REFERENCES               Belshe RB, Graham BS, Keefer MC, Gorse GJ,
                          Wright P, Dolin R, Matthews T, Weinhold K,
                          Bolognesi DP, Sposto R, et al. Neutralizing
                          antibodies to HIV-1 in seronegative
                          volunteers immunized with recombinant gp120
                          from the MN strain of HIV-1. NIAID AIDS
                          Vaccine Clinical Trials Network [see
                          comments]. JAMA. 1994 Aug 10;272(6):475-80.
 REFERENCES               Francis DP, Fast P, Harkonen S, McElrath MJ,
                          Belshe R, Berman P, Gregory T. MN rgp120
                          (Genentech) vaccine safe and immunogenic--but
                          will it protect humans? The AIDS Vaccine
                          Evaluation Group. Int Conf AIDS. 1994 Aug
                          7-12;10(1):90 (abstract no. 314A).
 REFERENCES               Belshe R, Keefer M, Graham B, Matthews T,
                          Twaddell T, Fast P. Safety and immunogenicity
                          of HIV-1 (MN or combination MN/IIB) 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-B27-1).
 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).
 ENTRY MONTH              9212
 LAST REVISION DATE       960307
 

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