Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: A phase 3 randomised double-blind placebo-controlled trial

The Lancet Infectious Diseases

Volumn 15, Issue 12, 2015, Pages 1398-1408

  O'Brien, Katherine L ^a   Chandran, Aruna ^a   Weatherholtz, Robert ^a   Jafri, Hasan S ^b   Griffin, M Pamela ^b   Bellamy, Terramika ^b   Millar, Eugene V ^a   Jensen, Kathryn M ^b   Harris, Brian S ^b   Reid, Raymond ^a   Moulton, Lawrence H ^a   Losonsky, Genevieve A ^b   Karron, Ruth A ^a   Santosham, Mathuram ^a   Donaldson, Connie ^a   Eick Cost, Angie ^a   Perilla, Mindy ^a   Campbell, James ^a   VanDeReit, Daniel ^a   Brown, Laura B ^a   Gloyd, P William ^a   Seby, Michael ^a   Brown, Mark A ^c   Candelaria, Delfno ^d   Foti, Jeffrey L ^e   Overturf, Gary ^f   more..

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b MEDIMMUNE   (United States)

^c UNIVERSITY OF ARIZONA   (United States)

^d PHOENIX INDIAN MEDICAL CENTER   (United States)

^e SEATTLE CHILDREN S HOSPITAL   (United States)

^f UNIVERSITY OF NEW MEXICO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MOTAVIZUMAB; PLACEBO; ANTIVIRUS AGENT; MONOCLONAL ANTIBODY;

ALLERGIC REACTION; AMERICAN INDIAN; ARTICLE; AUTUMN; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ERYTHEMA; ERYTHEMA MULTIFORME; FEMALE; FOLLOW UP; GESTATIONAL AGE; HOSPITAL ADMISSION; HUMAN; HUMAN RESPIRATORY SYNCYTIAL VIRUS; HYPERSENSITIVITY; INFANT; INFECTION PREVENTION; INTENTION TO TREAT ANALYSIS; LOWER RESPIRATORY TRACT INFECTION; MALE; NORMAL HUMAN; OTITIS MEDIA; OUTCOME ASSESSMENT; PHARMACOLOGICAL PARAMETERS; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY SYNCYTIAL VIRUS INFECTION; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; TREATMENT DURATION; UNITED STATES; WHEEZING; CLINICAL TRIAL; ETHNOLOGY; HOSPITALIZATION; IMMUNOLOGY; NEWBORN; PATHOPHYSIOLOGY; PRESCHOOL CHILD; RESPIRATORY SOUNDS; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS; VIROLOGY;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIVIRAL AGENTS; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; FEMALE; HOSPITALIZATION; HUMANS; INDIANS, NORTH AMERICAN; INFANT; INFANT, NEWBORN; INTENTION TO TREAT ANALYSIS; MALE; RESPIRATORY SOUNDS; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS; RESPIRATORY SYNCYTIAL VIRUSES; UNITED STATES;

EID: 84960384015     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(15)00247-9     Document Type: Article

References (31)

1. Paramore LC, Ciuryla V, Ciesla G, Liu L Economic impact of respiratory syncytial virus-related illness in the US: an analysis of national databases. Pharmacoeconomics 2004, 22:275-284.
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. Boyce TG, Mellen BG, Mitchel EF, Wright PF, Griffin MR Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr 2000, 137:865-870.
4. Moler FW, Khan AS, Meliones JN, Custer JR, Palmisano J, Shope TC Respiratory syncytial virus morbidity and mortality estimates in congenital heart disease patients: a recent experience. Crit Care Med 1992, 20:1406-1413.
5. Horn SD, Smout RJ Effect of prematurity on respiratory syncytial virus hospital resource use and outcomes. J Pediatr 2003, 143:S133-S141.
6. Langley GF, Anderson LJ Epidemiology and prevention of respiratory syncytial virus infections among infants and young children. Pediatr Infect Dis J 2011, 30:510-517.
7. Welliver RC, Checchia PA, Bauman JH, Fernandes AW, Mahadevia PJ, Hall CB Fatality rates in published reports of RSV hospitalizations among high-risk and otherwise healthy children. Curr Med Res Opin 2010, 26:2175-2181.
8. Kneyber MCJ, Steyerberg EW, de Groot R, Moll HA Long-term effects of respiratory syncytial virus (RSV) bronchiolitis in infants and young children: a quantitative review. Acta Paediatr 2000, 89:654-660.
9. Banerji A, Lanctot KL, Paes BA, et al. Comparison of the cost of hospitalization for respiratory syncytial virus disease versus palivizumab prophylaxis in Canadian Inuit infants. Pediatr Infect Dis J 2009, 28:702-706.
10. Evers SE, Rand CG Morbidity in Canadian Indian and non-Indian children in the first year of life. Can Med Assoc J 1982, 126:249-252.
11. Evers SE, Rand CG Morbidity in Canadian Indian and non-Indian children in the second year. Can J Public Health 1983, 74:191-194.
12. Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ Bronchiolitis-associated hospitalizations among US children, 1980-1996. JAMA 1999, 282:1440-1446.
13. Singleton RJ, Bruden D, Bulkow LR, Varney G, Butler JC Decline in respiratory syncytial virus hospitalizations in a region with high hospitalization rates and prolonged season. Pediatr Infect Dis J 2006, 25:1116-1122.
14. Bockova J, O'Brien KL, Oski J, et al. Respiratory syncytial virus infection in Navajo and White Mountain Apache children. Pediatrics 2002, 110:e20.
15. Stockman LJ, Curns AT, Anderson LJ, Fischer-Langley G Respiratory syncytial virus-associated hospitalizations among infants and young children in the United States, 1997-2006. Pediatr Infect Dis J 2012, 31:5-9.
16. Holman RC, Curns AT, Cheek JE, et al. Respiratory syncytial virus hospitalizations among American Indian and Alaska Native infants and the general United States infant population. Pediatrics 2004, 114:e437-e444.
17. Palivizumab Full Prescribing Information, MedImmune, Gaithersburg, MD, 2014 (accessed Oct 15, 2015). https://www.medimmune.com/docs/default-source/pdfs/prescribing-information-for-synagis.pdf.
18. 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. Committee on Infectious Diseases.
19. Hu A, Colella M, Tam JS, Rappaport R, Cheng SM Simultaneous detection, subgrouping, and quantitation of respiratory syncytial virus A and B by real-time PCR. J Clin Microbiol 2003, 41:149-154.
20. Carbonell-Estrany X, Simoes EA, Dagan R, et al. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics 2010, 125:e35-e51.
21. 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.
22. Simoes EA, Groothuis JR, Carbonell-Estrany X, et al. Palivizumab prophylaxis, respiratory syncytial virus, and subsequent recurrent wheezing. J Pediatr 2007, 151:34-42.
23. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 1998, 102:531-537. The IMpact-RSV Study Group.
24. 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.
25. Blanken MO, Rovers MM, Molenaar JM, et al. Respiratory syncytial virus and recurrent wheeze in healthy preterm infants. N Engl J Med 2013, 368:1791-1799.
26. Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009, 360:588-598.
27. Regnier SA, Huels J Association between respiratory syncytial virus hospitalizations in infants and respiratory sequelae: systematic review and meta-analysis. Pediatr Infect Dis J 2013, 32:820-826.
28. Simoes EA, Carbonell-Estrany X, Rieger CH, et al. The effect of respiratory syncytial virus on subsequent recurrent wheezing in atopic and nonatopic children. J Allergy Clin Immunol 2010, 126:256-262.
29. Karron RA Respiratory syncytial virus and parainfluenza virus vaccines. Vaccines 2012, 1146-1153. Elsevier, Philadelphia, PA. 6th edn. S. Plotkin, W. Orenstein, P. Offit (Eds.).
30. RSV vaccine snapshot, (accessed April 21, 2015). http://sites.path.org/vaccinedevelopment/files/2011/12/RSV-snapshot-March2015.pdf.
31. Robbie GJ, Criste R, Dall'acqua WF, et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother 2013, 57:6147-6153.