      Document 0025
 DOCN  DRG0025
 UNIQUE IDENTIFIER        DRG-0222
 NAME OF SUBSTANCE        HIV p17/p24:Ty-VLP [AIDS 1993 Oct;7(10)]
 PROTOCOL ID NUMBERS      NIAID VEU 019
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Vaccine delivery system with
                          the potential for inducing broadly
                          cross-reactive CD8+ cytotoxic T-lymphocyte
                          (CTL) responses to p17 and p24. A previous
                          study indicated that hybrid p17/p24:Ty-VLP
                          was capable of inducing both cellular and
                          humoral immunity to HIV-1 gag p17 and p24
                          components. [AIDS 1993 Oct;7(10); NIAID VEU
                          019]
 DISEASES STUDIED/TREATED Prevention of HIV infection [NIAID VEU 019]
 CLASSIFICATION CODE      Vaccine [AIDS 1993 Oct;7(10)]
 ADVERSE EFFECTS          Adverse effects of the intramuscular
                          injection may include pain, soreness,
                          redness, and swelling at the injection site.
                          Other adverse effects may include fever,
                          chills, rash, aches, pains, nausea, headache,
                          and fatigue. Side effects after rectal
                          administration of the vaccine may include
                          local discomfort, crampy abdominal pain, or
                          watery diarrhea immediately following
                          injection. [NIAID VEU 019]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Fusion product of the gag
                          gene of HIV-1 IIIB and a gene from the yeast
                          retrotransposon. Retrotransposons are
                          transposable elements (transposons) that
                          involve a retrovirus-like process of reverse
                          transcription [NIAID VEU 019] [MeSH]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The TYA-gag fusion gene
                          produces a protein that retains the
                          self-assembly properties of the
                          retrotransposon and thereby expresses the
                          HIV-1 gag gene products p17 and p24 in a
                          virus-like particle (VLP) [NIAID VEU 019]
                          [MeSH]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The fusion protein contains
                          amino acids 1-381 of yeast protein p1, 33
                          C-terminal amino acids of p17, and 177 amino
                          acids of p24 (not including the 48 C-terminal
                          amino acids of p24) [NIAID VEU 019] [MeSH]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Together the p17 and p24
                          components comprise 30 percent of the mass
                          [NIAID VEU 019] [MeSH]
 CHEMICAL/PHYSICAL DATA   MOLECULAR WEIGHT: 66,460 D [NIAID VEU 019]
 CHEMICAL/PHYSICAL DATA   STABILITY: Virus-like particles (VLPs)
                          adjuvanted with aluminum hydroxide (alum) are
                          stable at 4 C for at least 30 months [NIAID
                          VEU 019]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Adjuvanted with alum or
                          unadjuvanted. [NIAID VEU 019]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular; oral;
                          rectal. [NIAID VEU 019]
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Store adjuvanted
                          formulation at 4 C. Store unadjuvanted
                          formulation at -70 C. [NIAID VEU 019]
 MANUFACTURERS            British Biotech PLC
 REFERENCES               Weber J, Cheinsong-Popov R, Callow D, Adams
                          S, Patou G, Hodgkin K, Martin S, Gotch F,
                          Kingsman A. Immunogenicity of the yeast
                          recombinant p17/p24:Ty virus-like particles
                          (p24-VLP) in healthy volunteers. Vaccine.
                          1995 Jun;13(9):831-4.
 REFERENCES               Brookman JL, Stott AJ, Cheeseman PJ, Adamson
                          CS, Holmes D, Cole J, Burns NR. Analysis of
                          TYA protein regions necessary for formation
                          of the Ty1 virus-like particle structure.
                          Virology;VOL 212,ISS 1,1995,P69-76.
 REFERENCES               Luo L, Li Y, Dales S, Kang CY. Mapping of
                          functional domains for HIV-2 gag assembly
                          into virus-like particles. Virology; VOL
                          205,ISS 2,1994,P496-502.
 REFERENCES               Martin SJ, Vyakarnam A, Cheingsong-Popov R,
                          Callow D, Jones KL, Senior JM, Adams SE,
                          Kingsman AJ, Matear P, Gotch FM, et al.
                          Immunization of human HIV-seronegative
                          volunteers with recombinant p17/p24:Ty
                          virus-like particles elicits HIV-1
                          p24-specific cellular and humoral immune
                          responses. AIDS 1993 Oct;7(10):1315-23.
 ENTRY MONTH              9505
 LAST REVISION DATE       960424
 

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