      Document 0188
 DOCN  DRG0188
 UNIQUE IDENTIFIER        DRG-0059
 NAME OF SUBSTANCE        HIVAC-1e [J Clin Immunol 1992 Nov;12(6)]
 SYNONYMS                 Recombinant vaccinia virus v-env5NY [NIAID
                          VEU 002]
 SYNONYMS                 Recombinant vaccinia virus expressing the
                          HIV-1 gp160 envelope glycoprotein [J Clin
                          Immunol 1992 Nov; 12(6)]
 SYNONYMS                 Human immunodeficiency virus type 1 (HIV-1)
                          gp 160 recombinant vaccinia virus [J Infect
                          Dis 1992 Aug;166(2)]
 PROTOCOL ID NUMBERS      NIAID VEU 002
 PROTOCOL ID NUMBERS      FDA 063A
 PROTOCOL ID NUMBERS      NIAID VEU 010
 PROTOCOL ID NUMBERS      NIAID VEU 008
 PROTOCOL ID NUMBERS      NIAID VEU 002A
 PROTOCOL ID NUMBERS      NIAID VEU 002B
 IND NUMBER               BB2957
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: HIVAC-1e has been shown to
                          induce antibodies to gp160 more frequently in
                          vaccinia-naive persons than has been reported
                          for vaccine positive persons. HIV-1 specific
                          Ab and LP responses appear to be more
                          persistent in HIVAC-1e immunized persons than
                          in persons immunized with rgp160 alone HIVAC
                          works as an immune system primer for subunit
                          boosting. An additional boost with soluble
                          recombinant gp160 after priming with HIVAC-1e
                          provides a significant benefit in the
                          magnitude of HIV-specific antibody response,
                          but offers no enhancement in functional
                          antibody activity. Cellular immunity is
                          stimulated with an additional boost with
                          soluble recombinant gp160 (VaxSyn,
                          MicroGeneSys). [Int Conf AIDS 1992 Jul
                          19-24;8(1):Mo9 (abstract no. MoB 0027)] [Int
                          Conf AIDS 1991 Jun 16-21;7(2): (abstract no.
                          FA 1)]
 DISEASES STUDIED/TREATED Prevention of AIDS [J Clin Immunol 1992
                          Nov;12(6)]
 CLASSIFICATION CODE      Vaccine [J Clin Immunol 1992 Nov;12(6)]
 ADVERSE EFFECTS          (Human data unavailable.)  None of the
                          animals tested (mice, monkeys, and
                          chimpanzees) developed any untoward effects
                          due to immunization.  All recombinant viruses
                          produced localized cutaneous lesions typical
                          of vaccinia virus.  Risks are those of
                          vaccinations:  risk of accidental spread of
                          vaccine virus infection to other parts of the
                          body of a vaccinated person or to his or her
                          contacts.  Less common but more serious
                          complications include abnormal skin
                          eruptions, disorders affecting the nervous
                          system, and other rare or less severe
                          reactions. [VEU 002]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: HIVAC-1e vaccine is a
                          sterile suspension of a live vaccinia
                          v-env5NY virus in phosphate buffered saline
                          [VEU 002]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The v-env5NY virus is
                          produced in human diploid cells MRC-5 at a
                          concentration of 2(+ or -1) x 10-9
                          plaque-forming units (PFU)/ml [VEU 002]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: It was created to contain
                          the entire coding sequence of the envelope
                          glycoproteins of HIV-1 [VEU 002]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The vaccinia viral vector
                          used is a derivative of the NY Board of
                          Health strain obtained by plaque purification
                          from a commercial preparation of smallpox
                          vaccine using plaque purifications in tissue
                          culture cells [VEU 002]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM:  Sterile, frozen suspension in
                          capped, labeled vials containing 2 + or - 1 x
                          10-9 plaque-forming units (pfu)/ml. [NIAID
                          VEU 002]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY:  Vaccination
                          (scarification). [NIAID VEU 002]
 SUBSTANCE DELIVERY DATA  STORAGE:  Store at < -10 C. [NIAID VEU 002]
 MANUFACTURERS            Bristol-Myers
 REFERENCES               Graham BS, Gorse GJ, Schwartz DH, Keefer MC,
                          McElrath MJ, Matthews TJ, Wright PF, Belshe
                          RB, Clements ML, Dolin R, et al. Determinants
                          of antibody response after recombinant gp160
                          boosting in vaccinia-naive volunteers primed
                          with gp160-recombinant vaccinia virus. J
                          Infect Dis. 1994 Oct;170(4):782-6.
 REFERENCES               Graham BS, Belshe RB, Clements ML, Dolin R,
                          Corey L, Wright PF, Gorse GJ, Midthun K,
                          Keefer MC, Roberts NJ Jr, et al. Vaccination
                          of vaccinia-naive adults with human
                          immunodeficiency virus type 1 gp160
                          recombinant vaccinia virus in a blinded,
                          controlled, randomized clinical trial. The
                          AIDS Vaccine Clinical Trials Network. J
                          Infect Dis. 1992 Aug;166(2):244-52.
 REFERENCES               McElrath J, Peterson E, Dragavon J, Berger D,
                          Hoffman M, Klucking S, Greenberg P, Corey L.
                          Combination prime-boost approach to HIV
                          vaccination in seronegative individuals:
                          enhanced immunity with additional subunit
                          gp160 protein boosting. Int Conf AIDS. 1992
                          Jul 19-24;8(1):Mo9 (abstract no. MoB 0027).
 REFERENCES               Graham BS, Belshe R, Clements ML, Dolin R,
                          Fernie B, Stablein D, Wright P, Koff W.
                          HIV-GP160 recombinant vaccinia vaccination of
                          vaccinia-naive adults followed by RGP160
                          booster immunization. Int Conf AIDS. 1991 Jun
                          16-21;7(2):88 (abstract no. F.A.1).
 REFERENCES               Cooney EL, Collier AC, Greenberg PD, Coombs
                          RW, Zarling J, Arditti DE, Hoffman MC, Hu SL,
                          Corey L. Safety of and immunological response
                          to a recombinant vaccinia virus vaccine
                          expressing HIV envelope glycoprotein [see
                          comments]. Lancet. 1991 Mar
                          9;337(8741):567-72.
 REFERENCES               Keefer MC, Bonnez W, Roberts NJ Jr, Lambert
                          J, Dolin R, Reichman R. HIV-1 rgp160-specific
                          cellular immune responses by recipients of a
                          live vaccinia-rgp160 vaccine. Int Conf AIDS.
                          1990 Jun 20-23;6(2):326 (abstract no. 1051).
 REFERENCES               Smith G, Volvovitz F. Vaxsyn HIV-1 (RPG160)
                          vaccine recipients demonstrate functional
                          immune responses classically associated with
                          protective immunity. Int Conf AIDS. 1990 Jun
                          20-23;6(3):114 (abstract no. S.A.75).
 REFERENCES               Cooney EL, Corey L, Hu SL, Collier A, Arditti
                          D, Hoffman M, Smith G, Steimer K, Greenberg
                          P. Enhanced immunogenicity in humans of an
                          HIV subunit vaccine regimen employing priming
                          with a vaccinia gp160 recombinant virus
                          (vac/env) by boosting with recombinant HIV
                          envelope glycoprotein (rgp160). Int Conf
                          AIDS. 1990 Jun 20-23;6(1):203 (abstract no.
                          Th.A.333).
 REFERENCES               Cooney EL, Zarling J, Hu SL, Watson A, Corey
                          L, Greenberg P. T cell responses to HIV in
                          humans immunized with recombinant vaccinia
                          virus containing HIV envelope. Int Conf AIDS.
                          1989 Jun 4-9;5:538 (abstract no. Th.C.O.34)
 ENTRY MONTH              8910
 LAST REVISION DATE       960314
 

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