The pharmacokinetics, antigenicity, and fusion-inhibition activity of RSHZ19, a humanized monoclonal antibody to respiratory syncytial virus, in healthy volunteers

Journal of Infectious Diseases

Volumn 174, Issue 3, 1996, Pages 463-469

  Everitt, Daniel E ^a   Davis, Charles B ^a   Thompson, Kathleen ^a   DiCicco, Robert ^a   Ilson, Bernard ^a   Demuth, Sandra G ^a   Herzyk, Danuta J ^a   Jorkasky, Diane K ^a  

^a PENN PRESBYTERIAN MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY RSHZ19; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ANTIGENICITY; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; IMMUNOTHERAPY; INTRAVENOUS DRUG ADMINISTRATION; MALE; NORMAL HUMAN; PASSIVE IMMUNIZATION; PLASMA CLEARANCE; PRIORITY JOURNAL; VERO CELL; VIRUS PNEUMONIA;

EID: 0029757417     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/174.3.463     Document Type: Article

References (31)

1. McIntosh K, Chanock RM. Respiratory syncytial virus. In: Fields BN, Knipe DM, Chanock RM, et al., eds. Virology. New York: Raven Press, 1990:1045-72.
2. McIntosh K. Pathogenesis of severe acute respiratory infections in the developing world: respiratory syncytial virus and parainfluenza viruses. Immunology 1991;13(suppl 6):S492-500.
3. La Via WV, Marks MI, Stutman HR. Respiratory syncytial virus puzzle: clinical features, pathophysiology, treatment and prevention. Pediatrics 1992;121:503-10.
4. Fernald GW, Almond JR, Henderson FH. Cellular and humoral immunity in recurrent respiratory syncytial virus infections. Pediatr Res 1983;17:753-8.
5. Hall CB, Walsh EE, Long CE, Schnabel KC. Immunity to and frequency of reinfection with respiratory syncytial virus. J Infect Dis 1991;163:693-8.
6. Olmsted RA, Elango N, Prince GA, et al. Expression of the F1 glycoprotein of respiratory syncytial virus: comparison of the individual contribution of the F and G glycoproteins to host immunity. Proc Natl Acad Sci USA 1986;83:7462-6.
7. Stott EJ, Taylor G, Ball LA, et al. Immune and histopathological responses in animals vaccinated with recombinant vaccinia viruses that express individual genes of human respiratory syncytial virus. J Virol 1987;61:3855-61.
8. Walsh EE, Schlesinger JJ, Brandiss MW. Protection from respiratory syncytial virus infection in cotton rats by passive transfer of monoclonal antibodies. Infect Immun 1984;43:756-8.
9. Taylor G, Stott EJ, Bew M, et al. Monoclonal antibodies protect against respiratory syncytial virus infection in mice. Infect Immun 1984;43:649-55.
10. Tempest PR, Bremner P, Lambert M, et al. Reshaping a human monoclonal antibody to inhibit human respiratory syncytial virus infection in vivo. Biotechnology 1991;9:266-71.
11. Davis CB, Hepburn TW, Urbanski JJ, et al. Pre-clinical pharmacokinetic evaluation of the respiratory syncytial virus-specific reshaped human monoclonal antibody RSHZ19. Drug Metab Dispos 1995;23:1028-36.
12. Beeler JA, Coelingh KLVW. Neutralization epitopes of the F glycoprotein of respiratory syncytial virus: effect of mutation upon fusion function. J Virol 1989;63:2941-50.
13. Allen GD. MODFIT: a pharmacokinetics computer program. Biopharm Drug Dispos 1990;11:477-98.
14. Gibaldi M, Perrier D. Pharmacokinetics. 2nd ed. New York: Marcel Dekker, 1982.
15. Shand DG, Desjardins RE, Bjornsson TD, Hamill SC, Pritchett ELC. The method of separate exponentials: a simple aid to devising intravenous drug-loading regimens. Clin Pharmacol Ther 1981;29:542-7.
16. Groothuis JR, Simoes EAF, Levin MJ, et al. Prophylactic administration of respiratory syncytial virus immune globulin to high-risk infants and young children. N Engl J Med 1993;329:1524-30.
17. Davies B, Morris T. Physiological parameters in laboratory animals and humans. Pharmacol Res 1993;10:1093-5.
18. Lee ML, Mankarious S, Ochs H, et al. The pharmacokinetics of total IgG, IgG subclasses, and type specific antibodies in immunodeficient patients. Immunol Invest 1991;20:193-8.
19. Henry R, Begent J, Pedley RB. Monoclonal antibody administration: current clinical pharmacokinetic status and future trends. Clin Pharmacokinet 1992;23:85-9.
20. Russell SJ, Llewelyn MB, Hawkins RE. Principles of antibody therapy. BMJ 1992;305:1424-9.
21. Sequeira LA, Cutler RE. Muromonab CD3 (Orthoclone OKT3). Part 2. Adverse effects, clinical trials, and therapeutic use. Dial Transplant June 1992;353-68.
22. LoBuglio AF, Wheler RH, Trang J, et al. Mouse/human chimeric monoclonal antibody in man: kinetics and immune response. Proc Natl Acad Sci USA 1989;86:4220-4.
23. Azuma J, Kurimoto T, Tsuji S, et al. Phase I study on human monoclonal antibody against cytomegalovirus: pharmacokinetics and immunogenicity. J Immunother 1991;10:278-85.
24. Isaacs JD, Watts RA, Hazleman BL, et al. Humanised monoclonal antibody therapy for rheumatoid arthritis. Lancet 1992;340:748-52.
25. Prince GA, Horswood RL, Chanock RM. Quantitative aspects of passive immunity to respiratory syncytial virus infection in infant cotton rats. J Virol 1985;55:517-20.
26. Prince GA, Hemming VG, Horswood RL, Chanock RM. Immunoprophylaxis and immunotherapy of respiratory syncytial virus infection in the cotton rat. Virus Res 1985;3:193-206.
27. Glezen WP, Paredes A, Allison JE, Taber LH, Frank AL. Risk of respiratory syncytial virus infection for infants from low-income families in relationship to age, sex, ethnic group, and maternal antibody level. J Pediatr 1981;98:708-15.
28. Lamprecht CL, Krause HE, Mufson MA. Role of maternal antibody in pneumonia and bronchiolitis due to respiratory syncytial virus. J Infect Dis 1976;134:211-7.
29. Siber GR, Leszczynski J, Pena-Cruz V, et al. Protective activity of a human respiratory syncytial virus immune globulin prepared from donors screened by microneutralization assay. J Infect Dis 1992;165:456-63.
30. Taylor G, Stott EJ, Furze J, Ford J, Sopp P. Protective epitopes on the fusion protein of respiratory syncytial virus recognized by murine and bovine monoclonal antibodies. J Gen Virol 1992;73:2217-23.
31. Wyde PR, Moore DL, Hepburn T, et al. Evaluation of the protective efficacy of reshaped human monoclonal antibody RSHZ19 against respiratory syncytial virus in cotton rats. Pediatr Res 1995;38:543-50.