      Document 0140
 DOCN  DRG0140
 UNIQUE IDENTIFIER        DRG-0107
 NAME OF SUBSTANCE        Env 2-3 [AmFAR Tx Dir 1995;7(4)]
 SYNONYMS                 HIV Env 2-3 antigen [NIAID VEU 005]
 SYNONYMS                 ENV 2,3 (recombinant gp120) [AmFAR Tx Dir
                          1995;7(4)]
 PROTOCOL ID NUMBERS      NIAID VEU 005C
 PROTOCOL ID NUMBERS      NIAID VEU 103
 PROTOCOL ID NUMBERS      NIAID VEU 008
 PROTOCOL ID NUMBERS      NIAID ACTG 214
 PROTOCOL ID NUMBERS      NIAID VEU 005A/B
 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. Researchers have
                          shown Env 2-3 to stimulate production of
                          antibodies against the envelope glycoprotein,
                          gp120 of HIV. Evidence of CD4 cell priming
                          and lymphoproliferative responses have also
                          been observed. [AmFAR Tx Dir 1995;7(4)]
 DISEASES STUDIED/TREATED Primary HIV infection [AmFAR Tx Dir
                          1995;7(4)]
 CLASSIFICATION CODE      Vaccine [AmFAR Tx Dir 1995;7(4)]
 SUBSTANCE INTERACTIONS   Interacts with immunosuppressive medications.
                          [NIAID VEU 005]
 ADVERSE EFFECTS          ENV 2,3 alone is well tolerated. Researchers
                          have shown that 40% of patients who received
                          ENV 2,3 with MTP-PE experienced severe
                          local or systemic reactions including
                          malaise, myalgia, headache and moderate
                          fever. Those who received vaccine without
                          adjuvant experienced severe local or systemic
                          reactions at a rate of 7-8%. [AmFAR Tx Dir
                          1995;7(4)]
 CONTRAINDICATIONS        Contraindicated in patients with history of
                          immunodeficiency, chronic illness, or
                          autoimmune disease. [NIAID VEU 005]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: ENV 2,3 is a
                          non-glycosylated, fully denatured recombinant
                          polypeptide modeled on envelope glycoprotein
                          gp120 [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: It is derived from the SF-2
                          strain of HIV-1 and propagated in yeast cells
                          [AmFAR Tx Dir 1995;7(4)]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 55 kd [NIAID VEU 005]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Clear solution [NIAID
                          VEU 005]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Single dose vials in a sterile
                          aqueous solution of 0.35 ml per vial. [AmFAR
                          Tx Dir 1995;7(4)] [NIAID VEU 005]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Can be administered alone, but
                          also has been administered with an
                          oil-in-water emulsion adjuvant containing
                          MTP-PE/MF59. [AmFAR Tx Dir 1995;7(4)] [NIAID
                          VEU 005]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY:  IM injection. [AmFAR Tx
                          Dir 1995;7(4)]
 SUBSTANCE DELIVERY DATA  STORAGE: Keep frozen below -10 C. Thaw at 45
                          C for one hour to solubolize the antigen
                          contents. Bring vial to room temperature.
                          [NIAID VEU 005]
 SUBSTANCE DELIVERY DATA  STORAGE: Vortex lightly for about 5 seconds.
                          Before use, make sure the solution is clear
                          (or slightly opalescent) with no visible
                          particulates. [NIAID VEU 005]
 SUBSTANCE DELIVERY DATA  STORAGE: Inject as soon as possible, but no
                          longer than 4 hours after preparation. [NIAID
                          VEU 005]
 MANUFACTURERS            BIOCINE
 REFERENCES               Keefer M, Graham B, McElrath J, Matthews T,
                          Chernoff D, Dolin R. Phase I trial of an
                          HIV-1 vaccine candidate, Env 2-3, in
                          combination with MTP-PE/MF59. Int Conf AIDS.
                          1993 Jun 6-11;9(1):252 (abstract no.
                          PO-A29-0708).
 REFERENCES               Corey L, McElrath J, Keefer M, Paxton W,
                          Sposto R, Chernoff D. A phase I HIV-1 vaccine
                          trial in asymptomatic HIV-infected
                          individuals using Env 2-3 in MF-59 with or
                          without MTP-PE. Int Conf AIDS. 1993 Jun
                          6-11;9(1):494 (abstract no. PO-B28-2152).
 REFERENCES               McElrath J, Keefer M, Greenberg P, Sposto R,
                          Chernoff D, Steimer K. Evaluation of a
                          nonglycosylated yeast-derived envelope
                          vaccine on HIV-1 specific immunity in a
                          randomized, blinded, controlled HIV-1
                          seropositive trial. Int Conf AIDS. 1993 Jun
                          6-11;9(1):246 (abstract no. PO-A28-0670).
 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               Dolin R, Corey L, Graham B, Wright P,
                          McElrath J, Keefer M, Matthews T, Stablein D,
                          Dekker C. Safety and immunogenicity of an HIV
                          vaccine candidate, env 2-3, in combination
                          with MTP-PE/MF59. Int Conf AIDS. 1992 Jul
                          19-24;8(2):A40 (abstract no. PoA 2226).
 REFERENCES               Wintsch J, Chaignat CL, Braun DG, Jeannet M,
                          Stalder H, Abrignani S, Montagna D, Clavijo
                          F, Moret P, Dayer JM, et al. Safety and
                          immunogenicity of genetically engineered
                          immunodeficiency virus vaccine. J Infect Dis.
                          1991 Feb;163(12):219-25.
 ENTRY MONTH              9103
 LAST REVISION DATE       951213
 

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