      Document 0041
 DOCN  DRG0041
 UNIQUE IDENTIFIER        DRG-0206
 NAME OF SUBSTANCE        TBC-3B Vaccine [NIAID VEU 014]
 SYNONYMS                 TBC-3B [NIAID VEU 014]
 SYNONYMS                 Recombinant vaccina HIV-1 III B env/gag/pol
                          vaccine [NIAID VEU 014]
 PROTOCOL ID NUMBERS      NIAID VEU 014
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Insertion of the HIV-1
                          (strain IIIB) env, gag, and pol genes, each
                          under the transcriptional direction of a
                          vaccinia promoter element, into the genome of
                          this parental virus resulted in the
                          generation of a multivalent recombinant virus
                          that efficiently expresses fully processed,
                          authentically configured HIV-1 polypeptides
                          encoded by those genes. In animal studies,
                          this vaccine presented multiple conserved and
                          variable HIV-1 epitopes to the immune system,
                          and elicits both humoral and cell mediated
                          immune responses to the expressed
                          polypeptides. [NIAID VEU 014]
 DISEASES STUDIED/TREATED Prevention of HIV infection [NIAID VEU 014]
 CLASSIFICATION CODE      Vaccine [NIAID VEU 014]
 ADVERSE EFFECTS          Adverse effects include possible tenderness,
                          redness, and swelling at site of vaccination.
                          [NIAID VEU 014]
 CONTRAINDICATIONS        Contraindicated in pregnant and lactating
                          women. [NIAID VEU 014]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Live recombinant vaccinia
                          virus that expresses the env, gag, and pol
                          genes of HIV-1 (IIIB strain) [NIAID VEU 014]
 CHEMICAL/PHYSICAL DATA   STABILITY: Stable for 12 months at -75 to -85
                          C [NIAID VEU 014]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Vials containing 3 billion
                          PFU/ml. [NIAID VEU 014]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Scarification by bifurcated
                          needle. [NIAID VEU 014]
 SUBSTANCE DELIVERY DATA  STORAGE: Freeze at -75 to -85 C. Can remain
                          thawed at 4 C for 4 days. [NIAID VEU 014]
 MANUFACTURERS            Therion Biologics Corporation
 REFERENCES               Hesselton RM, Mazzara GP, Panicali D,
                          Sullivan JL. HIV-specific immune responses in
                          rabbits immunized with HIV-like particles and
                          recombinant vaccinia virus. Int Conf AIDS.
                          1992 Jul 19-25;8(1):Mo13 (abstract no. MoA
                          0045).
 ENTRY MONTH              0494
 LAST REVISION DATE       951115
 

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