      Document 0067
 DOCN  DRG0067
 UNIQUE IDENTIFIER        DRG-0180
 NAME OF SUBSTANCE        ALVAC-HIV gp160 MN (vCP125) [NIAID VEU 012A]
 SYNONYMS                 Recombinant canarypox-gp160 MN [NIAID VEU
                          012A]
 SYNONYMS                 ALVAC gp160 MN recombinant [NIAID VEU 012A]
 SYNONYMS                 ALVAC vCP125 HIV-1 gp160 MN [NIAID VEU 012A]
 SYNONYMS                 ALVAC vectored HIV gp160 vaccine (vCP125)
                          [NIAID VEU 012A]
 SYNONYMS                 ALVAC-HIV (v CP125) [AIDS Res Hum
                          Retroviruses 1995 Mar;11(3)]
 PROTOCOL ID NUMBERS      NIAID VEU 012A
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Like vaccinia virus,
                          canarypox can accommodate large amounts of
                          foreign DNA in its genome, infect mammalian
                          cells, and cause them to produce foreign
                          proteins. In contrast to vaccinia virus,
                          canarypox virus is host-range restricted.
                          That is, it goes through an abortive cycle of
                          replication and does not produce infectious
                          progeny virus in mammalian cells. Mice,
                          guinea pigs, and rabbits inoculated
                          intramuscularly with ALVAC gp160 10 to the
                          5.7th TCID50/ml at 0 and 4 weeks, produced
                          antibodies against gp160. Further, spleen
                          cells from mice inoculated twice with ALVAC
                          gp160 demonstrated significant gp160
                          lymphoproliferative responses. In six
                          macaques injected intramuscularly with 0.5 ml
                          of ALVAC gp160 at 0 and 4 weeks, no toxicity
                          was observed, and one of the six produced
                          significant levels of HIV-1 gp160 specific
                          antibody. Results of test for acute toxicity
                          in mice or rats receiving 2.5 or 5 times the
                          human dose i.v. were negative. [NIAID VEU
                          012A] [J Leukoc Biol 1995 Jul;58(1)]
 DISEASES STUDIED/TREATED Prevention of HIV infection [NIAID VEU 012A]
 CLASSIFICATION CODE      Vaccine [NIAID VEU 012A]
 ADVERSE EFFECTS          Adverse effects may include mild to moderate
                          local and systemic reactions which resolve
                          within 72 h of immunization. [AIDS Res Hum
                          Retroviruses 1995 Mar;11(3)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: A live canarypox
                          recombinant vaccine [NIAID VEU 012A] [AIDS
                          Res Hum Retroviruses 1995 Mar;11(3)]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Produced by homologous
                          recombination between the plasmid pC5HIVMNE
                          and the genomic DNA of ALVAC (canarypox),
                          thereby substituting the gp160 gene for the
                          open reading frame C5 [NIAID VEU 012A] [AIDS
                          Res Hum Retroviruses 1995 Mar;11(3
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The gp160 gene is under the
                          control of the vaccinia H6 promoter [NIAID
                          VEU 012A] [AIDS Res Hum Retroviruses 1995
                          Mar;11(3)]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White to cream,
                          homogeneous powder (lyophilized product);
                          pale rose-pink liquid, slightly opalescent
                          (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 1,000,000 TCID50 of ALVAC vCP125.
                          [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               Gonczol E, Berensci K, Pincus S, Endresz V,
                          Meric C, Paoletti E, Plotkin SA. Preclinical
                          evaluation of an ALVAC (carnarypox)--human
                          cytomegalovirus glycoprotein B vaccine
                          candidate. Vaccine 1995 Aug;13(12):1080-5.
 REFERENCES               Franchini G, Robert-Guroff M, Tartaglia J,
                          Aggarwal A, Abimiku A, Benson J, Markham P,
                          Limbach K, Hurteau G, Fullen J, et al. Highly
                          attenuated HIV type 2 recombinant poxviruses,
                          but not HIV-2 recombinant Salmonella
                          vaccines, induce long-lasting protection in
                          rhesus macaques. AIDS Res Hum Retroviruses.
                          1995 Aug;11(8):909-20.
 REFERENCES               Pincus S, Tartaglia J, Paoletti E.
                          Poxvirus-based vectors as vaccine candidates.
                          Biologicals 1995 Jun;23(2):159-64.
 REFERENCES               Pialoux G, Excler JL, Riviere Y,
                          Gonzalez-Canali G, Feuillie V, Coulaud P,
                          Gluckman JC, Matthews TJ, Meignier B, Kieny
                          MP, et al. A prime-boost approach to HIV
                          preventive vaccine using a recombinant
                          canarypox virus expressing glycoprotein 160
                          (MN) followed by a recombinant glycoprotein
                          160 (MN/LAI). The AGIS Group, and l'Agence
                          Nationale de Recherche sur le SIDA [published
                          erratum appears in AIDS Res Hum Retrovirus
                          1995 Jul:11(7):875]. AIDS Res Hum
                          Retroviruses. 1995 Mar;11(3):373-81.
 REFERENCES               Egan MA, Pavlat WA, Tartaglia J, Paoletti E,
                          Weinhold KJ, Clements ML, Siliciano RF.
                          Induction of human immunodeficiency virus
                          type 1 (HIV-1)-specific cytolytic T
                          lymphocyte responses in seronegative adults
                          by a nonreplicating, host-range-restricted
                          canarypox vector (ALVAC) carrying the HIV-1MN
                          env gene. J Infect Dis. 1995
                          Jun;171(6):1623-7.
 REFERENCES               Paoletti E, Taylor J, Meignier B, Meric C,
                          Tartaglia J. Highly attenuated poxvirus
                          vectors: NYVAC, ALVAC and TROVAC. Dev Biol
                          Stand 1995;84:159-63.
 REFERENCES               Taylor J, Tartaglia J, Riviere M, Duret C,
                          Languet B, Chappuis G, Paoletti E.
                          Applications of canarypox (ALVAC) vectors in
                          human and veterinary vaccination. Dev Biol
                          Stand 1994;82:131-5.
 REFERENCES               Riviere Y, Janvier G, Fleury B, Autran B,
                          Excler JL, Pialoux G, Salmon D, Siccard D,
                          Paoletti E, Plotkin S. Induction of CTL
                          activity in response to immunization of
                          uninfected adult volunteers by a HIV-gp160
                          canarypox virus. Int Conf AIDS. 1994 Aug
                          7-12;10(1):91 (abstract no. 315A).
 REFERENCES               Paoletti E, Tartaglia J, Taylor J. Safe and
                          effective poxvirus vectors--NYVAC and ALVAC.
                          Dev Biol Stand. 1994;82:65-9.
 REFERENCES               Gilles P, Gonzalez-Canali G, Gluckman JC,
                          Riviere Y, Plotkin S, Excler JL. Combination
                          prime-boost approach to HIV vaccination in
                          seronegative individuals using a recombinant
                          canarypox virus expressing MN-gp160 and a
                          MN-BRU-rgp 160 protein boosting (ANRS-VAC01).
                          Int Conf AIDS. 1993 Jun 6-11;9(1):70
                          (abstract no. WS-B27-6).
 ENTRY MONTH              9307
 LAST REVISION DATE       960417
 

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