      Document 0144
 DOCN  DRG0144
 UNIQUE IDENTIFIER        DRG-0103
 NAME OF SUBSTANCE        rgp120/HIV-1SF2 [NIAID VEU 015]
 SYNONYMS                 SF-2 rgp120/HIV-1 [NIAID VEU 015]
 SYNONYMS                 gp120 (CHO) [AmFAR Tx Dir 1995;7(4)]
 SYNONYMS                 SF2 rgp120 [NIAID ACTG 230]
 PROTOCOL ID NUMBERS      NIAID VEU 007C
 PROTOCOL ID NUMBERS      NIAID VEU 008
 PROTOCOL ID NUMBERS      NIAID VEU 010
 PROTOCOL ID NUMBERS      NIAID VEU 201
 PROTOCOL ID NUMBERS      NIAID VEU 007A/B
 PROTOCOL ID NUMBERS      NIAID ACTG 218
 PROTOCOL ID NUMBERS      NIAID ACTG 214
 PROTOCOL ID NUMBERS      NIAID ACTG 230
 PROTOCOL ID NUMBERS      NIAID VEU 012A
 PROTOCOL ID NUMBERS      NIAID VEU 015
 PROTOCOL ID NUMBERS      NIAID VEU 024
 PROTOCOL ID NUMBERS      NIAID VEU 026
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: The molecule is fully
                          glycosylated, a llowing it to closely
                          simulate the three-dimensional structure of
                          naturally occuring gp120. rgp120(CHO) is
                          expressed in Chinese hamster ovary cells.
                          rgp120(CHO) has been administered with a
                          combination of adjuvant muramyl tripeptide
                          (MTP-PE) and an emulsion (MF59). MF59 may
                          also have some adjuvant properties. It has
                          been theorized that subunit vaccines
                          consisting of HIV antigens may stimulate
                          humoral and lymphoproliferative cellular
                          immune responses. Steimer et al report that
                          conformation-dependent antibodies to gp120
                          neutralize divergent strains of HIV-1. The
                          conformational similarity of rgp120 CHO to
                          the native gp120 may have positive
                          implications for its ability to block primary
                          infection of diverse HIV-1 strains. Kahn et
                          al report that rgp120 (CHO) has stimulated
                          antibodies to gp120 that have persisted at
                          least three months. Forty-two HIV-negative
                          patients were randomized to six arms,
                          corresponding to increasing doses of MTP-PE,
                          ranging from 0-300 micrograms. Within each
                          arm, six patients received 25 micrograms
                          rgp120 (CHO) in MF59 emulsion and two
                          patients received MTP-PE alone. Three
                          injections were administered. The best
                          responses appear to be correlated with higher
                          doses of MTP-PE. [AmFAR Tx Dir 1995;7(4)]
                          [AmFAR Tx Dir 1993;6(3)]
 DISEASES STUDIED/TREATED Primary HIV infection / prevention [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 and any experimental
                          agents. [NIAID VEU 008] [AmFAR Tx Dir
                          1995;7(4)]
 ADVERSE EFFECTS          Mild myalgia, headache, and low-grade fever
                          are the most common adverse effects. [AmFAR
                          Tx Dir 1995;7(4)]
 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] [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: SF-2 rgp120 (CHO) is a
                          recombinant form of envelope glycoprotein
                          gp120 derived from HIV-1 strain SF-2 [AmFAR
                          Tx Dir 1995;7(4)]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Single dose vials as solution.
                          [NIAID VEU 015]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular injection
                          (IM). [AmFAR Tx Dir 1993;6(3)] [AmFAR Tx Dir
                          April, 1991] [AmFAR Tx Dir 1995;7(4)]
 SUBSTANCE DELIVERY DATA  STORAGE: Store frozen at -70 C or colder.
                          [NIAID VEU 015]
 MANUFACTURERS            The BIOCINE Company
 REFERENCES               Kahn J, Chernoff D, Sinangil F, Murcar N,
                          Wynne D, Coleman R, Haigwood N, Steimer K,
                          Dekker C. Phase 1 dose escalation MTP-PE
                          study of an HIV-1 gp120 vaccine in
                          sero-negative adults. Int Conf AIDS. 1992 Jul
                          19-24;8(1):Mo9 (abstract no. MoB 0025).
 REFERENCES               Steimer KS, Haigwood NL. Immunization of
                          primates with native, recombinant HIV-SF2
                          gp120 generates broadly effective
                          neutralizing antibodies directed to
                          conformational epitopes. AIDS Res Hum
                          Retroviruses. 1992 Aug;8(8):1391.
 REFERENCES               Haigwood N, Yoshiyama H, McClure J, Ho DD,
                          Steimer KS. Neutralization of primary HIV-1
                          isolates by sera from primates immunized with
                          recombinant HIV-SF2 gp120. Int Conf AIDS.
                          1992 Jul 19-24;8(1):Tu27 (abstract no. TuA
                          0504).
 REFERENCES               Steimer KS, Skiles P, Scandella C, Doe B,
                          Haigwood N. Neutralizing antibodies effective
                          against multiple HIV-1 isolates specific for
                          conformational-dependent epitopes in HIV-1
                          gp120. Int Conf AIDS. 1990 Jun 20-23;6(3):115
                          (abstract no. S.A.77).
 ENTRY MONTH              9102
 LAST REVISION DATE       960514
 

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