      Document 0066
 DOCN  DRG0066
 UNIQUE IDENTIFIER        DRG-0181
 NAME OF SUBSTANCE        ALVAC-RG rabies glycoprotein (vCP65) [NIAID
                          VEU 012A]
 SYNONYMS                 ALVAC RG [NIAID VEU 012A]
 SYNONYMS                 ALVAC vCP65 rabies glycoprotein [NIAID VEU
                          012A]
 SYNONYMS                 ALVAC RG (vCP65) [NIAID VEU 012A]
 PROTOCOL ID NUMBERS      NIAID VEU 012A
 PROTOCOL ID NUMBERS      NIAID VEU 022
 PROTOCOL ID NUMBERS      NIAID VEU 026
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: ALVAC-RG has been safe and
                          immunogenic when administered to mice, dogs,
                          cats, rhesus macaques, chimpanzees, and human
                          volunteers. Protection against lethal rabies
                          challenge has been achieved in mice, dogs,
                          and cats using ALVAC vCP65 rabies
                          glycoprotein vaccine. The live recombinant
                          canarypox-rabies glycoprotein vaccine has
                          been tested in 15 adult volunteers in
                          Baltimore, MD., and in 15 volunteers in
                          France. The immune response following
                          vaccination appeared to be dose dependent,
                          with detection of protective levels of serum
                          antibody against rabies after two
                          immunizations in 90% of those who received
                          the two highest doses in Baltimore and in 77%
                          of the French volunteers. Cell-mediated
                          immune responses were also detected. [NIAID
                          VEU 012A] [Lancet 1992 Jun 13;339(8807)]
 DISEASES STUDIED/TREATED Used as control in vaccine studies [NIAID VEU
                          012A]
 CLASSIFICATION CODE      Vaccine [NIAID VEU 012A]
 ADVERSE EFFECTS          Adverse effects include mild transient pain
                          at the inoculation site. [NIAID VEU 012A]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: A recombinant canarypox
                          virus bearing the rabies virus glycoprotein G
                          gene under transcriptional control of the
                          vaccinia virus H6 promoter [NIAID VEU 012A]
                          [Lancet 1992 Jun 13;339(8807)]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Cream, homogeneous
                          powder (lyophilized product); clear liquid
                          (reconstituted product) [NIAID VEU 012A]
 CHEMICAL/PHYSICAL DATA   STABILITY: Thermostable at ambient
                          temperatures [NIAID VEU 012A]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Vaccine is supplied as a sterile
                          lyophilized product in single dose vials
                          containing 10 to the 5.5 TCID50 of ALVAC
                          vCP65. [NIAID VEU 012A]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Vaccine preparation is
                          given intramuscularly with a 22 gauge 1.5
                          inch needle into the right or left deltoid
                          muscle after preparation of the site with
                          alcohol. [NIAID VEU 012A]
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Refrigerate at 3-5 C.
                          Do not freeze. [NIAID VEU 012A]
 MANUFACTURERS            Pasteur Merieux Serums et Vaccins
 REFERENCES               Perkus ME, Tartaglia J, Paoletti E.
                          Poxvirus-based vaccine candidates for cancer,
                          AIDS, and other infectious diseases. J Leukoc
                          Biol. 1995 Jul;58(1):1-13.
 REFERENCES               Taylor J, Meignier B, Tartaglia J, Languet B,
                          VanderHoeven J, Franchini G, Trimarchi C,
                          Paoletti E. Biological and immunogenic
                          properties of a canarypox-rabies recombinant,
                          ALVAC-RG (vCP65) in non-avian species.
                          Vaccine 1995 Apr; 13(6):539-49.
 REFERENCES               Plotkin SA, Cadoz M, Meignier B, Meric C,
                          Leroy O, Excler JL, Tartaglia J, Paoletti E,
                          Gonczol E, Chappuis G. The safety and use of
                          canarypox vectored vaccines. Dev Biol Stand.
                          1995;84:165-70.
 REFERENCES               Fries LF, Shahan J, Thumus B, Tartaglia J,
                          Taylor J, Meignier B, Paoletti E. Safety and
                          immunogenicity of a canarypox-rabies
                          glycoprotein recombinant in adult human
                          volunteers. 32nd ICAAC Meeting, Anaheim, CA
                          1992.
 REFERENCES               Cadoz M, Strady A, Meignier B, Taylor J,
                          Tartaglia J, Paoletti E, Plotkin S.
                          Immunisation with canarypox virus expressing
                          rabies glycoprotein [see comments]. Lancet.
                          1992;339:1429-1432.
 REFERENCES               Ferguson M, Heath A. Report of a
                          collaborative study to assess the
                          determination of glycoprotein antigen content
                          of rabies vaccines for human use.
                          Biologicals. 1992 Jun;20(2):143-54.
 ENTRY MONTH              9307
 LAST REVISION DATE       960514
 

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