Antibodies for prevention and treatment of respiratory syncytial virus infections in children

Antiviral Therapy

Volumn 17, Issue 1 PART B, 2012, Pages 201-211

  Geevarghese, Bessey ^a   Simões, Eric A F ^a,b,c  

^a Children's Hospital Colorado   (United States)

^b CHILDREN S HOSPITAL COLORADO   (United States)

^c Global Health and Health Disparities   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FELVIZUMAB; HNK 20; IMMUNOGLOBULIN; IMMUNOGLOBULIN A; MEDI 557; MONOCLONAL ANTIBODY; MOTAVIZUMAB; NEUTRALIZING ANTIBODY; PALIVIZUMAB; PLACEBO; POLYCLONAL ANTIBODY; RESPIRATORY SYNCYTIAL VIRUS ANTIBODY; RESPIRATORY SYNCYTIAL VIRUS VACCINE; RIBAVIRIN; UNCLASSIFIED DRUG;

ANTIBODY TITER; ARTIFICIAL VENTILATION; CONGENITAL HEART DISEASE; DISEASE SEVERITY; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG COST; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SAFETY; FEVER; FLUID THERAPY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HIGH RISK PATIENT; HOSPITALIZATION; HUMAN; HYPERVOLEMIA; IMMUNE DEFICIENCY; IMMUNOPROPHYLAXIS; INFECTION PREVENTION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; MULTICENTER STUDY (TOPIC); NEUROMUSCULAR DISEASE; NONHUMAN; OXYGEN SATURATION; OXYGEN THERAPY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RECOMMENDED DRUG DOSE; RESPIRATORY SYNCYTIAL PNEUMOVIRUS; RESPIRATORY SYNCYTIAL VIRUS INFECTION; RESPIRATORY TRACT DISEASE; REVIEW; RISK ASSESSMENT; SIDE EFFECT; SKIN MANIFESTATION; TREATMENT OUTCOME; UNITED STATES;

ANTIBODIES, MONOCLONAL; ANTIBODIES, VIRAL; CHILD; HUMANS; IMMUNOTHERAPY; INFANT; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS; RESPIRATORY SYNCYTIAL VIRUSES; RISK FACTORS;

EID: 84860343998     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: 10.3851/IMP2061     Document Type: Review

References (81)

1. Hall CB. Respiratory syncytial virus and parainfluenza virus. N Engl J Med 2001; 344:1917-1928. (Pubitemid 32553362)
2. Nair H, Nokes DJ, Gessner BD, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 2010; 375:1545-1555.
3. Falsey AR, Walsh EE, Capellan J, et al. Comparison of the safety and immunogenicity of 2 respiratory syncytial virus (rsv) vaccines-nonadjuvanted vaccine or vaccine adjuvanted with alum-given concomitantly with influenza vaccine to high-risk elderly individuals. J Infect Dis 2008; 198:1317-1326.
4. Simões EA. Respiratory syncytial virus infection. Lancet 1999; 354:847-852. (Pubitemid 29415599)
5. Sigurs N, Gustafsson PM, Bjarnason R, et al. Severe respiratory syncytial virus bronchiolitis in infancy and asthma and allergy at age 13. Am J Respir Crit Care Med 2005; 171:137-141. (Pubitemid 40105412)
6. Stein RT, Sherrill D, Morgan WJ, et al. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet 1999; 354:541-545. (Pubitemid 29381367)
7. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child 1986; 140:543-546. (Pubitemid 16120909)
8. Stensballe LG, Ravn H, Kristensen K, Meakins T, Aaby P, Simões EA. Seasonal variation of maternally derived respiratory syncytial virus antibodies and association with infant hospitalizations for respiratory syncytial virus. J Pediatr 2009; 154:296-298.e1.
9. The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 1998; 102:531-537.
10. Feltes TF, Cabalka AK, Meissner HC, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr 2003; 143:532-540. (Pubitemid 37352516)
11. Hall CB, McBride JT, Walsh EE, et al. Aerosolized ribavirin treatment of infants with respiratory syncytial viral infection. A randomized double-blind study. N Engl J Med 1983; 308:1443-1447. (Pubitemid 13103444)
12. Ventre K, Randolph AG. Ribavirin for respiratory syncytial virus infection of the lower respiratory tract in infants and young children. Cochrane Database Syst Rev 2007; 1:CD000181.
13. Collins PL, et al. In Knipe DM, Howley PM, Griffin DE, et al. (Editors). Field's virology. 5th Ed. Philadelphia: Lippincott Williams & Wilkins 2007; pp. 1601-1646.
14. Empey KM, Peebles RS, Jr., Kolls JK. Pharmacologic advances in the treatment and prevention of respiratory syncytial virus. Clin Infect Dis 2010; 50:1258-1267.
15. Sullender WM. Respiratory syncytial virus genetic and antigenic diversity. Clin Microbiol Rev 2000; 13:1-15. (Pubitemid 30039340)
16. Chin J, Magoffin RL, Shearer LA, Schieble JH, Lennette EH. Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population. Am J Epidemiol 1969; 89:449-463.
17. Kapikian AZ, Mitchell RH, Chanock RM, Shvedoff RA, Stewart CE. An epidemiologic study of altered clinical reactivity to respiratory syncytial (RS) virus infection in children previously vaccinated with an inactivated RS virus vaccine. Am J Epidemiol 1969; 89:405-421.
18. Kim HW, Canchola JG, Brandt CD, et al. Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. Am J Epidemiol 1969; 89:422-434.
19. Fulginiti VA, Eller JJ, Sieber O F, Joyner J W, Minamitani M, Meiklejohn G. Respiratory virus immunization. I. A field trial of two inactivated respiratory virus vaccines; an aqueous trivalent parainfluenza virus vaccine and an alum-precipitated respiratory syncytial virus vaccine. Am J Epidemiol 1969; 89:435-448.
20. Murphy BR, Prince GA, Walsh EE, et al. Dissociation between serum neutralizing and glycoprotein antibody responses of infants and children who received inactivated respiratory syncytial virus vaccine. J Clin Microbiol 1986; 24:197-202. (Pubitemid 16061007)
21. Polack F P, Teng MN, Collins PL, et al. A role for immune complexes in enhanced respiratory syncytial virus disease. J Exp Med 2002; 196:859-865.
22. Kim HW, Leikin SL, Arrobio J, Brandt CD, Chanock RM, Parrott RH. Cell-mediated immunity to respiratory syncytial virus induced by inactivated vaccine or by infection. Pediatr Res 1976; 10:75-78.
23. Openshaw PJ, Tregoning JS. Immune responses and disease enhancement during respiratory syncytial virus infection. Clin Microbiol Rev 2005; 18:541-555. (Pubitemid 40995115)
24. Castilow EM, Varga SM. Overcoming T cell-mediated immunopathology to achieve safe RSV vaccination. Future Virol. 2008; 3:445-454.
25. Johnson TR, Teng MN, Collins PL, Graham BS. Respiratory syncytial virus (RSV) G glycoprotein is not necessary for vaccine-enhanced disease induced by immunization with formalin-inactivated RSV. J Virol 2004; 78:6024-6032. (Pubitemid 38661690)
26. Prince GA, Horswood RL, Chanock RM. Quantitative aspects of passive immunity to respiratory syncytial virus infection in infant cotton rats. J Virol 1985; 55:517-520. (Pubitemid 16249655)
27. Olszewska W, Openshaw P. Emerging drugs for respiratory syncytial virus infection. Expert Opin Emerg Drugs 2009; 14:207-217.
28. Hemming VG, Rodriguez W, Kim HW, et al. Intravenous immunoglobulin treatment of respiratory syncytial virus infections in infants and young children. Antimicrob Agents Chemother 1987; 31:1882-1886. (Pubitemid 18009554)
29. Siber GR, Leombruno D, Leszczynski J, et al. Comparison of antibody concentrations and protective activity of respiratory syncytial virus immune globulin and conventional immune globulin. J Infect Dis 1994; 169:1368-1373. (Pubitemid 24164608)
30. Simões EA, Groothuis JR. Respiratory syncytial virus prophylaxis - the story so far. Respir Med 2002; 96 Suppl B:S15-S24. (Pubitemid 39665386)
31. Groothuis JR, Simões EA, Levin MJ, et al. Prophylactic administration of respiratory syncytial virus immune globulin to high-risk infants and young children. N Engl J Med 1993; 329:1524-1530. (Pubitemid 23332437)
32. Meissner HC, Fulton DR, Groothuis JR, et al. Controlled trial to evaluate protection of high-risk infants against respiratory syncytial virus disease by using standard intravenous immune globulin. Antimicrob Agents Chemother 1993; 37:1655-1658. (Pubitemid 23226378)
33. Simões EA. Immunoprophylaxis of respiratory syncytial virus: global experience. Respir Res 2002; 3 Suppl 1:S26-S33.
34. Groothuis JR, Simões EA, Hemming VG. Respiratory syncytial virus (RSV) infection in preterm infants and the protective effects of RSV immune globulin (RSVIG). Pediatrics 1995; 95:463-467.
35. Welliver RC. Respiratory syncytial virus immunoglobulin and monoclonal antibodies in the prevention and treatment of respiratory syncytial virus infection. Semin Perinatol 1998; 22:87-95. (Pubitemid 28162332)
36. The PREVENT Study Group. Reduction of respiratory syncytial virus hospitalization among premature infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. Pediatrics 1997; 99:93-99.
37. Simões EA, Sondheimer HM, Top FH, Jr., et al. Respiratory syncytial virus immune globulin for prophylaxis against respiratory syncytial virus disease in infants and children with congenital heart disease. J Pediatr 1998; 133:492-499. (Pubitemid 28465374)
38. Simões EA, Groothuis JR, Tristram DA, et al. Respiratory syncytial virus-enriched globulin for the prevention of acute otitis media in high risk children. J Pediatr 1996; 129:214-219. (Pubitemid 27483792)
39. Wenzel SE, Gibbs RL, Lehr MV, Simões EA. Respiratory outcomes in high-risk children 7 to 10 years after prophylaxis with respiratory syncytial virus immune globulin. Am J Med 2002; 112:627-633. (Pubitemid 34597163)
40. Rodriguez WJ, Gruber WC, Welliver RC, et al. Respiratory syncytial virus (RSV) immune globulin intravenous therapy for RSV lower respiratory tract infection in infants and young children at high risk for severe RSV infections: Respiratory Syncytial Virus Immune Globulin Study Group. Pediatrics 1997; 99:454-461. (Pubitemid 27176021)
41. Rodriguez WJ, Gruber WC, Groothuis JR, et al. Respiratory syncytial virus immune globulin treatment of RSV lower respiratory tract infection in previously healthy children. Pediatrics 1997; 100:937-942. (Pubitemid 27516476)
42. Empire Blue Cross Blue Shield Medical Policy. Prevention of respiratory syncytial virus infections. (Accessed 3 January 2011.) Available from http://www.empireblue.com/provider/noapplication/f2/s5/t9/pw-ad084861.pdf
43. Clinicaltrials.gov. Clinical trials and RSV. (Updated 10 July 2010. Accessed 4 January 2012.) Available from http://clinicaltrials.gov/ct2/show/ NCT00632463
44. Weltzin R, Monath T P. Intranasal antibody prophylaxis for protection against viral disease. Clin Microbiol Rev 1999; 12:383-393. (Pubitemid 29330135)
45. Meissner HC, Groothuis JR, Rodriguez WJ, et al. Safety and pharmacokinetics of an intramuscular monoclonal antibody (SB 209763) against respiratory syncytial virus (RSV) in infants and young children at risk for severe RSV disease. Antimicrob Agents Chemother 1999; 43:1183-1188. (Pubitemid 29214744)
46. Siva Subramanian KN, Weisman LE, Rhodes T, et al. Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. Pediatr Infect Dis J 1998; 17:110-115. (Pubitemid 28096007)
47. Wright M, Piedimonte G. Respiratory syncytial virus prevention and therapy: past, present, and future. Pediatr Pulmonol 2011; 46:324-347.
48. Johnson S, Oliver C, Prince GA, et al. Development of a humanized monoclonal antibody (MEDI-493) with potent in vitro and in vivo activity against respiratory syncytial virus. J Infect Dis 1997; 176:1215-1224. (Pubitemid 27460986)
49. Johnson S, Griego SD, Pfarr DS, et al. A direct comparison of the activities of two humanized respiratory syncytial virus monoclonal antibodies: MEDI-493 and RSHZl9. J Infect Dis 1999; 180:35-40. (Pubitemid 29293914)
50. Mullins JA, Lamonte AC, Bresee JS, Anderson LJ. Substantial variability in community respiratory syncytial virus season timing. Pediatr Infect Dis J 2003; 22:857-863.
51. Stensballe LG, Devasundaram JK, Simões EA. Respiratory syncytial virus epidemics: the ups and downs of a seasonal virus. Pediatr Infect Dis J 2003; 22:S21-S32. (Pubitemid 36228149)
52. From the American Academy of Pediatrics. Policy statements - modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009; 124:1694-1701.
53. Simões EA, Carbonell-Estrany X, Fullarton JR, et al. A predictive model for respiratory syncytial virus (RSV) hospitalisation of premature infants born at 33-35 weeks of gestational age, based on data from the Spanish FLIP Study. Respir Res 2008; 9:78.
54. Carbonell-Estrany X, Simões EA, Fullarton JR, Ferdynus C, Gouyon JB. Validation of a model to predict hospitalization due to RSV of infants born at 33-35 weeks' gestation. J Perinat Med 2010; 38:411-417.
55. Simões EA, Carbonell-Estrany X, Fullarton JR, Rossi GA, Barberi I, Lanari M. European risk factors' model to predict hospitalization of premature infants born 33-35 weeks' gestational age with respiratory syncytial virus: validation with Italian data. J Matern Fetal Neonatal Med 2011; 24:152-157.
56. Stensballe LG, Fullarton JR, Carbonell-Estrany X, Simões EA. Population based external validation of a European predictive model for respiratory syncytial virus hospitalization of premature infants born 33 to 35 weeks of gestational age. Pediatr Infect Dis J 2010; 29:374-376.
57. Sampalis JS, Langley J, Carbonell-Estrany X, et al. Development and validation of a risk scoring tool to predict respiratory syncytial virus hospitalization in premature infants born at 33 through 35 completed weeks of gestation. Med Decis Making 2008; 28:471-480. (Pubitemid 351989998)
58. Paes B, Cole M, Latchman A, Pinelli J. Predictive value of the respiratory syncytial virus risk-scoring tool in the term infant in Canada. Curr Med Res Opin 2009; 25:2191-2196.
59. Law BJ, Langley JM, Allen U, et al. The Pediatric Investigators Collaborative Network on Infections in Canada study of predictors of hospitalization for respiratory syncytial virus infection for infants born at 33 through 35 completed weeks of gestation. Pediatr Infect Dis J 2004; 23:806-814. (Pubitemid 40221021)
60. Simões EA, Groothuis JR, Carbonell-Estrany X, et al. Palivizumab prophylaxis, respiratory syncytial virus, and subsequent recurrent wheezing. J Pediatr 2007; 151:34-42.e1.
61. Simões EA, Carbonell-Estrany X, Rieger CH, Mitchell I, Fredrick L, Groothuis JR. The effect of respiratory syncytial virus on subsequent recurrent wheezing in atopic and nonatopic children. J Allergy Clin Immunol 2010; 126:256-262.
62. American Academy of Pediatrics Committee on Infectious Diseases and Committee on Fetus and Newborn. Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. Pediatrics 2003; 112:1442-1446.
63. Malley R, DeVincenzo J, Ramilo O, et al. Reduction of respiratory syncytial virus (RSV) in tracheal aspirates in intubated infants by use of humanized monoclonal antibody to RSV F protein. J Infect Dis 1998; 178:1555-1561. (Pubitemid 28558122)
64. Sáez-Llorens X, Moreno MT, Ramilo O, Sanchez PJ, Top FH, Jr., Connor EM. Safety and pharmacokinetics of palivizumab therapy in children hospitalized with respiratory syncytial virus infection. Pediatr Infect Dis J 2004; 23:707-712. (Pubitemid 39063284)
65. Meissner HC, Bocchini JA, Jr., Brady MT, Hall CB, Kimberlin DW, Pickering LK. The role of immunoprophylaxis in the reduction of disease attributable to respiratory syncytial virus. Pediatrics 2009; 124:1676-1679.
66. ElHassan NO, Sorbero ME, Hall CB, Stevens TP, Dick AW. Cost-effectiveness analysis of palivizumab in premature infants without chronic lung disease. Arch Pediatr Adolesc Med 2006; 160:1070-1076. (Pubitemid 44520638)
67. Smart KA, Lanctot KL, Paes BA. The cost effectiveness of palivizumab: a systematic review of the evidence. J Med Econ 2010; 13:453-463.
68. Prescott WA, Jr., Doloresco F, Brown J, Paladino JA. Cost effectiveness of respiratory syncytial virus prophylaxis: a critical and systematic review. Pharmacoeconomics 2010; 28:279-293.
69. Wu H, Pfarr DS, Johnson S, et al. Development of motavizumab, an ultra-potent antibody for the prevention of respiratory syncytial virus infection in the upper and lower respiratory tract. J Mol Biol 2007; 368:652-665. (Pubitemid 46527610)
70. Abarca K, Jung E, Fernandez P, et al. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J 2009; 28:267-272.
71. Carbonell-Estrany X, Simões EA, Dagan R, et al. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics 2010; 125:e35-e51.
72. MedImmune. MEDI-524 (Motavizumab) for the prevention of respiratory syncytial virus (RSV) disease among Native American Indian infants in the Southwestern United States. (Updated 4 May 2011. Accessed 3 January 2012.) Available from http://clinicaltrials.gov/ct2/show/NCT00121108?term= medi+524&rank=6
73. Cingoz O. Motavizumab. MAbs. 2009; 1:439-442.
74. Feltes TF, Sondheimer HM, Tulloh RM, et al. A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease. Pediatr Res 2011; 70:186-191.
75. Krilov LR. Respiratory syncytial virus disease: update on treatment and prevention. Expert Rev Anti Infect Ther 2011; 9:27-32.
76. Lagos R, DeVincenzo J P, Munoz A, et al. Safety and antiviral activity of motavizumab, a respiratory syncytial virus (RSV)-specific humanized monoclonal antibody, when administered to RSV-infected children. Pediatr Infect Dis J 2009; 28:835-837.
77. Weisman LE. Respiratory syncytial virus (RSV) prevention and treatment: past, present, and future. Cardiovasc Hematol Agents Med Chem 2009; 7:223-233.
78. Junghans RP. Finally! The Brambell receptor (FcRB). Mediator of transmission of immunity and protection from catabolism for IgG. Immunol Res 1997; 16:29-57.
79. Dall'Acqua WF, Kiener PA, Wu H. Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn). J Biol Chem 2006; 281:23514-23524. (Pubitemid 44274126)
80. MedImmune. A Phase I, randomized, double-blind, single-dose, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of MEDI-557. (Updated 12 November 2011. Accessed 11 January 2012.) Available from http://clinicaltrials.gov/ct2/show/NCT00578682
81. Groothuis JR, Hoopes JM, Hemming VG. Prevention of serious respiratory syncytial virus-related illness. II: Immunoprophylaxis. Adv Ther 2011; 28:110-125.