      Document 0019
 DOCN  DRG0019
 UNIQUE IDENTIFIER        DRG-0228
 NAME OF SUBSTANCE        APL 400-003 [FDA 089]
 PROTOCOL ID NUMBERS      FDA 089
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Facilitated DNA inoculation
                          involves direct injection of noninfectious
                          HIV genes into a patient's muscle, along with
                          agents that promote uptake of the genes into
                          host cells. Host cells that have taken up
                          these genes then produce viral proteins in a
                          form that elicits immune responses in the
                          form of antibodies (which eradicate free
                          virus in the bloodstream), killer T-cells
                          (which destroy infected cells), and helper
                          T-cells (which expand the overall immune
                          response). The immune response is directed
                          against multiple sites and proteins of the
                          virus, giving the immune system many targets
                          for attacking the virus.  The vaccine does
                          not use a viral vector. Genes are taken up by
                          the host cells but are not integrated into
                          the host chromosomes; thus, there are no
                          permanent changes in the host's genetic
                          material. [U of Pennsylvania Press Release
                          06/16/95]
 DISEASES STUDIED/TREATED Primary HIV infection [FDA 089]
 CLASSIFICATION CODE      Vaccine [U of Pennsylvania Press Release
                          06/16/95]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Segment of DNA--called a
                          cassette--that incorporates different parts
                          of the HIV genome, including genes for the
                          envelope protein and a regulatory gene of the
                          virus [U of Pennsylvania Press Release
                          06/16/95]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intramuscular. [FDA 089]
 MANUFACTURERS            Apollon Inc
 REFERENCES               Girard M, Meignier B, Barre-Sinoussi F, Kieny
                          MP, Matthews T, Muchmore E, Nara PL, Wei Q,
                          Rimsky L, Weinhold K, et al. Vaccine-induced
                          protection of chimpanzees against infection
                          by a heterologous human immunodeficiency
                          virus type 1. J Virol. 1995
                          Oct;69(10):6239-48.
 REFERENCES               Wang B, Boyer J, Srikantan V, Ugen K, Gilbert
                          L, Phan C, Dang K, Merva M, Agadjanyan MG,
                          Newman M, et al. Induction of humoral and
                          cellular immune responses to the human
                          immunodeficiency type 1 virus in nonhuman
                          primates by in vivo DNA inoculation.
                          Virology. 1995 Aug 1;211(1):102-12.
 REFERENCES               Wang B, Boyer J, Srikantan V, Ugen K,
                          Agadjanian M, Merva M, Gilbert L, Dang K,
                          McCallus D, Moelling K, et al. DNA
                          inoculation induces cross clade anti-HIV-1
                          responses. Ann N Y Acad Sci. 1995 Nov
                          27;772:186-97.
 REFERENCES               Wang B, Merva M, Dang K, Ugen KE, Boyer J,
                          Williams WV, Weiner DB. DNA inoculation
                          induces protective in vivo immune responses
                          against cellular challenge with HIV-1
                          antigen-expressing cells. AIDS Res Hum
                          Retroviruses. 1994;10 Suppl 2:S35-41.
 REFERENCES               Wang B, Boyer J, Srikantan V, Coney L,
                          Carrano R, Phan C, Merva M, Dang K, Agadjanan
                          M, Gilbert L, et al. DNA inoculation induces
                          neutralizing immune responses against human
                          immunodeficiency virus type 1 in mice and
                          nonhuman primates. DNA Cell Biol. 1993
                          Nov;12(9):799-805.
 REFERENCES               Coney L, Wang B, Ugen KE, Boyer J, McCallus
                          D, Srikantan V, Agadjanyan M, Pachuk CJ,
                          Herold K, Merva M, et al. Facilitated DNA
                          inoculation induces anti-HIV-1 immunity in
                          vivo. Vaccine 1994 Dec;12(16):1545-50.
 ENTRY MONTH              9508
 LAST REVISION DATE       960424
 

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