      Document 0105
 DOCN  DRG0105
 UNIQUE IDENTIFIER        DRG-0142
 NAME OF SUBSTANCE        Hepatitis B Vaccine (Recombinant) [PDR 1995]
 SYNONYMS                 Engerix-B [PDR 1995]
 SYNONYMS                 Betagen [MeSH]
 SYNONYMS                 Recombivax HB [PDR 1995]
 SYNONYMS                 Recombivax-HB [MeSH]
 SYNONYMS                 Heptavax-B [USAN 1996]
 PROTOCOL ID NUMBERS      NIAID ACTG 205
 PROTOCOL ID NUMBERS      NIAID VEU 003
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Hepatitis B surface antigen,
                          which is present in hepatitis B virus vaccine
                          (recombinant), promotes the production of
                          antibody to hepatitis B surface antigen
                          (anti-HBs); anti-HBs neutralize the hepatitis
                          B virus so that its infectivity or pathogenic
                          properties are inhibited. Protection against
                          hepatitis B is virtually complete in
                          individuals who develop adequate antibody
                          levels after vaccination. [AHFS Drug
                          Information 1995]
 DISEASES STUDIED/TREATED Used as non-HIV viral vaccine control [NIAID
                          ACTG 205]
 CLASSIFICATION CODE      Vaccine [PDR 1995]
 OTHER MAJOR USES         Immunization against infection caused by all
                          known subtypes of hepatitis B virus [PDR
                          1995]
 ADVERSE EFFECTS          Generally well tolerated. No serious adverse
                          reactions attributable to the vaccine have
                          been reported during the course of clinical
                          trials. Injection site reactions (including
                          erythema and swelling) and systemic
                          complaints were reported in one trial
                          following 8% and 17% of the injections
                          respectively. [PDR 1995]
 CONTRAINDICATIONS        Hypersensitivity to yeast or any other
                          component of the vaccine is a
                          contraindication. [PDR 1995] Should be
                          administered with caution to individuals with
                          thrombocytopenia, or a bleeding disorder, or
                          with severely compromised cardiopulmonary
                          status, or to individuals in whom a febrile
                          or adverse systemic reaction could pose a
                          substantial risk. [AHFS Drug Information
                          1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Noninfectious recombinant
                          DNA hepatitis B vaccine [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: A recombinantly produced
                          hepatitis B surface antigen obtained from
                          genetically engineered Saccharomyces
                          cerevisiae (yeast) cells and adsorbed on
                          aluminum hydroxide [PDR 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Slightly opaque, white
                          sterile suspension [PDR 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 20 mcg/ml single-dose vials.
                          [PDR 1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular. [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store between 2 and 8 C. Do not
                          freeze. [PDR 1995]
 MANUFACTURERS            Smith Kline and French Laboratories
 MANUFACTURERS            Merck Sharp and Dohme
 REFERENCES               Arrazola MP, de Juanes Jr, Ramos JT, Aragon
                          AJ, Garcia de Codes A. Hepatitis B
                          vaccination in infants of mothers infected
                          with human immunodeficiency virus. J Med
                          Virol. 1995 Mar;45(3):339-41.
 REFERENCES               Muraskin WA. The role of organized labor in
                          combating the hepatitis B and AIDS epidemics:
                          the fight for an OSHA bloodborne pathogens
                          standard. Int J Health Serv.
                          1995;25(1):129-52.
 REFERENCES               Maris JM, Butler RB, Cohen AR. Loss of
                          detectable antibody to hepatitis B surface
                          antigen in immunized patients with hemophilia
                          but without human immunodeficiency virus
                          infection. J Pediatr. 1995 Feb;126(2):269-71.
 REFERENCES               Choudhury SA, Peters VB. Responses to
                          hepatitis B vaccine boosters in human
                          immunodeficiency virus-infected children.
                          Pediatr Infect Dis J. 1995 Jan;14(1):65-7.
 REFERENCES               Rutstein RM, Rudy B, Codispoti C, Watson B.
                          Response to hepatitis B immunization by
                          infants exposed to HIV. AIDS. 1994
                          Sep;8(9):1281-4.
 REFERENCES               Diamant EP, Schechter C, Hodes DS, Peters VB.
                          Immunogenicity of hepatitis B vaccine in
                          human immunodeficiency virus-infected
                          children. Pediatr Infect Dis J. 1993
                          Oct;12(10):877-8.
 REFERENCES               Zuccotti GV, Riva E, Flumine P, Locatelli V,
                          Fiocchi A, Tordato G, Giovannini M. Hepatitis
                          B vaccination in infants of mothers infected
                          with human immunodeficiency virus. J Pediatr.
                          1994 Jul;125(1):70-2.
 REFERENCES               Tabor E, Cairns J, Gerety RJ, Bayley AC.
                          Nine-year follow-up study of a plasma-derived
                          hepatitis B vaccine in a rural African
                          setting. J Med Virol. 1993 Jul;40(3):204-9.
 REFERENCES               Hessol NA, Koblin BA, van Griensven GJ,
                          Bacchetti P, Liu JY, Stevens CE, Coutinho RA,
                          Buchbinder SP, Katz MH. Progression of human
                          immunodeficiency virus type 1 (HIV-1)
                          infection among homosexual men in hepatitis B
                          vaccine trial cohorts in Amsterdam, New York
                          City, and San Francisco, 1978-1991. Am J
                          Epidemiol. 1994 Jun 1;139(11):1077-87.
 REFERENCES               van Griensven GJ, Hessol NA, Koblin BA, Byers
                          RH, O'Malley PM, Albercht-van Lent N,
                          Buchbinder SP, Talyor PE, Stevens CE,
                          Coutinho RA. Epidemiology of human
                          immunodeficiency virus type 1 infection among
                          homosexual men participating in hepatitis B
                          vaccine trials in Amsterdam, New York City,
                          and San Francisco, 1978-1990. Am J Epidemiol.
                          1993 Apr 15;137(8):909-15.
 ENTRY MONTH              9206
 LAST REVISION DATE       960307
 

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