A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season

BMC Pediatrics

Volumn 10, Issue , 2010, Pages

  Fernández, Pilar ^a   Trenholme, Adrian ^b   Abarca, Katia ^c   Griffin, M Pamela ^d   Hultquist, Micki ^d   Harris, Brian ^d   Losonsky, Genevieve A ^d  

^a HOSPITAL CLÍNICO UNIVERSIDAD DE CHILE   (Chile)

^b UNIVERSITY OF AUCKLAND   (New Zealand)

^c PONTIFICIA UNIVERSIDAD CATÓLICA DE CHILE   (Chile)

^d MEDIMMUNE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG ANTIBODY; MOTAVIZUMAB; PALIVIZUMAB; ANTIVIRUS AGENT; MEDI 524 MONOCLONAL ANTIBODY, HUMAN; MEDI-524 MONOCLONAL ANTIBODY, HUMAN; MONOCLONAL ANTIBODY;

ACUTE OTITIS MEDIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; BRONCHIOLITIS; BRONCHITIS; CHEMOPROPHYLAXIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIAPER DERMATITIS; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; ECZEMA; ERYTHEMA MULTIFORME; FEMALE; GASTROENTERITIS; GASTROESOPHAGEAL REFLUX; HIGH RISK PATIENT; HUMAN; INFANT; INFECTION PREVENTION; INGUINAL HERNIA; INJECTION SITE ERYTHEMA; IRRITABILITY; LIVER DYSFUNCTION; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUSCLE HYPERTONIA; NOSE CONGESTION; PATIENT COMPLIANCE; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY SYNCYTIAL VIRUS INFECTION; RHINITIS; RHINOPHARYNGITIS; RHINORRHEA; SEBORRHEIC DERMATITIS; SIDE EFFECT; STAPHYLOCOCCAL SCALDED SKIN SYNDROME; THRUSH; TOOTH ERUPTION; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VISUAL DISORDER; WHEEZING; DRUG ADMINISTRATION; INTRAMUSCULAR DRUG ADMINISTRATION; MULTICENTER STUDY; NEWBORN; PREMATURITY; RISK FACTOR;

ANTIBODIES, MONOCLONAL; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; HUMANS; INFANT, NEWBORN; INFANT, PREMATURE; INFANT, PREMATURE, DISEASES; INJECTIONS, INTRAMUSCULAR; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS; RISK FACTORS;

EID: 77954357242     PISSN: None     EISSN: 14712431     Source Type: Journal    
DOI: 10.1186/1471-2431-10-38     Document Type: Article

References (20)

1. Hall CB, Hall WJ. Bronchiolitis. Principles and Practice of Infectious Diseases 1995, 612-619. New York: Churchill Livingstone, Mandell GL, Bennett JE, Dolin R, 4.
2. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child (1960) 1986, 140:543-546.
3. 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. 10.2165/00019053-200422050-00001, 15061677.
4. Groothuis JR, Gutierrez KM, Lauer BA. Respiratory syncytial virus infection in children with bronchopulmonary dysplasia. Pediatrics 1988, 82:199-203.
5. Heilman CA. From the National Institute of Allergy and Infectious Diseases and the World Health Organization. Respiratory syncytial and parainfluenza viruses. J Infect Dis 1990, 161:402-406.
6. MacDonald NE, Hall CB, Suffin SC, Alexson C, Harris PJ, Manning JA. Respiratory syncytial viral infection in infants with congenital heart disease. N Engl J Med 1982, 307:397-400.
7. American Academy of Pediatrics Policy statement--Modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009, 124:1694-1701. 10.1542/peds.2009-2345, 19736258, American Academy of Pediatrics.
8. MedImmune Synagis® (palivizumab) package insert. July 2008, MedImmune.
9. Johnson S, Oliver C, Prince GA, Hemming VG, Pfarr DS, Wang SC, Dormitzer M, O'Grady J, Koenig S, Tamura JK, Woods R, Bansal G, Couchenour D, Tsao E, Hall WC, Young JF. 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. 10.1086/514115, 9359721.
10. Feltes TF, Cabalka AK, Meissner HC, Piazza FM, Carlin DA, Top FH, Connor EM, Sondheimer HM. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatrics 2003, 143:532-540.
11. Pedraz C, Carbonell-Estrany X, Figueras-Aloy J, Quero J. Effect of palivizumab prophylaxis in decreasing respiratory syncytial virus hospitalizations in premature infants. Pediatr Infect Dis J 2003, 22:823-827. 10.1097/01.inf.0000086403.50417.7c, 14506376.
12. The IMpact-RSV Study Group Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. The IMpact-RSV Study Group. Pediatrics 1998, 102:531-537. The IMpact-RSV Study Group.
13. Mejias A, Chávez-Bueno S, Ríos AM, Aten MF, Raynor B, Peromingo E, Soni P, Olsen KD, Kiener PA, Gómez AM, Jafri HS, Ramilo O. Comparative effects of two neutralizing anti-respiratory syncytial virus (RSV) monoclonal antibodies in the RSV murine model: time versus potency. Antimicrob Agents Chemother 2005, 49:4700-4707. 10.1128/AAC.49.11.4700-4707.2005, 1280119, 16251314.
14. Wu H, Pfarr DS, Tang Y, An LL, Patel NK, Watkins JD, Huse WD, Kiener PA, Young JF. Ultra-potent antibodies against respiratory syncytial virus: effects of binding kinetics and binding valence on viral neutralization. J Mol Biol 2005, 350:126-144. 10.1016/j.jmb.2005.04.049, 15907931.
15. Wu H, Pfarr DS, Johnson S, Brewah YA, Woods RM, Patel NK, White WI, Young JF, Kiener PA. 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. 10.1016/j.jmb.2007.02.024, 17362988.
16. Mejias A, Chavez-Bueno S, Raynor MB, Connolly J, Kiener PA, Jafri HS, Ramilo O. Motavizumab, a neutralizing anti-Respiratory Syncytial Virus (Rsv) monoclonal antibody significantly modifies the local and systemic cytokine responses induced by Rsv in the mouse model. Virol J 2007, 4:109. 10.1186/1743-422X-4-109, 2222633, 17961258.
17. Abarca K, Jung E, Fernandez P, Zhao L, Harris B, Connor EM, Losonsky GA. 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. 10.1097/INF.0b013e31818ffd03, 19258920.
18. Lagos R, Devincenzo JP, Munoz A, Hultquist M, Suzich J, Connor EM, Losonsky GA. 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. 10.1097/INF.0b013e3181a165e4, 19636278.
19. Malley R, DeVincenzo J, Ramilo O, Dennehy PH, Meissner HC, Gruber WC, Sanchez PJ, Jafri H, Balsley J, Carlin D, Buckingham S, Vernacchio L, Ambrosino DM. 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. 10.1086/314523, 9815203.
20. Carbonell-Estrany X, Simões EAF, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA, . Motavizumab Study Group Motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in high-risk children: A randomized controlled noninferiority trial. Pediatrics 2010, 125(1):e35-e51. 10.1542/peds.2008-1036, 20008423, Motavizumab Study Group.