A prospective, open-label, non-comparative study of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus disease in the Russian Federation

被引：10
作者：
Turti T.V. [1 ]
Baibarina E.N. [2 ]
Degtiareva E.A. [3 ]
Keshishyan E.S. [4 ]
Lobzin Y.V. [5 ]
Namazova-Baranova L.S. [1 ]
Prodeus A.P. [6 ]
Gudkov K.M. [7 ]
Kruglova A.I. [7 ]
Schulz G.A. [8 ]
Notario G.F. [8 ]
机构：
[1] Scientific Center of Children's Health, RAMS, Moscow, 119991, Lomonosovskiy Prospect
[2] Center for Obstetrics, Gynecology and Perinatology, Moscow
[3] Peoples' Friendship University of Russia, Moscow
[4] Moscow Science Research Institute of Pediatrics and Pediatric Surgery, Moscow
[5] Institute for Child Infections, St. Petersburg
[6] Federal Scientific Clinical Center of Pediatric Hematology, Oncology and Immunology, Moscow
[7] Abbott, Moscow
[8] Abbott, Abbott Park, IL
来源：
BMC Research Notes | / 5卷 / 1期
关键词：
Bronchopulmonary dysplasia; Congenital heart disease; Immunoprophylaxis; Lower respiratory tract infection; Preterm infant;
D O I：
10.1186/1756-0500-5-484
中图分类号：
学科分类号：
摘要：
Background: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTIs) in children globally. Predisposing conditions for the development of serious RSV disease include preterm infants and those with cardiopulmonary illness, including congenital heart disease (CHD) and bronchopulmonary dysplasia (BPD). No vaccine is currently approved for the prevention of RSV infection. It is recommended that children at high risk be prophylactically administered palivizumab, a monoclonal antibody that has been shown in a number of clinical studies to reduce hospitalization rates due to serious RSV infection. The objective of the current study was to determine the safety and effectiveness of palivizumab in preventing serious RSV disease in high-risk children in the Russian Federation. Children at high risk of serious RSV disease (ie, born at ≤35 wk gestational age and ≤6 mo of age, and/or aged ≤24 mo with BPD or hemodynamically significant CHD) were enrolled. Subjects were to receive 3 to 5 monthly injections of palivizumab 15 mg/kg (depending on the month of the initial injection) over the RSV season. The primary endpoint was RSV-related hospitalizations. Adverse events (AEs) were reported through 100 days following the final injection. Results: One hundred subjects received ≥1 injection of palivizumab; 94 completed their dosing schedule. There were no RSV hospitalizations or deaths. Six of 7 subjects hospitalized for respiratory/cardiac conditions had an RSV test, which was negative in all cases. Three non-serious AEs (acute intermittent rhinitis and rhinitis, 1 subject; atopic dermatitis, 1 subject) were considered possibly related to palivizumab. All other AEs were mild or moderate and considered not related/probably not related to palivizumab. Conclusion: Palivizumab was generally well tolerated and effectively prevented serious RSV infection in a mixed population of high-risk children in the Russian Federation. Trial registration. ClinicalTrials.gov: NCT01006629. © 2012 Turti et al.; licensee BioMed Central Ltd.
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  • [1] Nair H., Nokes D.J., Gessner B.D., Dherani M., Madhi S.A., Singleton R.J., O'Brien K.L., Roca A., Wright P.F., Bruce N., Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: A systematic review and meta-analysis, Lancet, 375, 9725, pp. 1545-1555, (2010)
  • [2] Tatochenko V., Uchaikin V., Gorelov A., Gudkov K., Campbell A., Schulz G., Prahl R., Notario G., Epidemiology of respiratory syncytial virus in children </=2 years of age hospitalized with lower respiratory tract infections in the Russian Federation: A prospective, multicenter study, Clin Epidemiol, 2, pp. 221-227, (2010)
  • [3] Oshansky C.M., Zhang W., Moore E., Tripp R.A., The host response and molecular pathogenesis associated with respiratory syncytial virus infection, Future Microbiol, 4, 3, pp. 279-297, (2009)
  • [4] Stollenwerk N., Harper R.W., Sandrock C.E., Bench-to-bedside review: Rare and common viral infections in the intensive care unit-linking pathophysiology to clinical presentation, Crit Care, 12, 4, (2008)
  • [5] Empey K.M., Peebles Jr. R.S., Kolls J.K., Pharmacologic advances in the treatment and prevention of respiratory syncytial virus, Clin Infect Dis, 50, 9, pp. 1258-1267, (2010)
  • [6] Tregoning J.S., Schwarze J., Respiratory viral infections in infants: Causes, clinical symptoms, virology, and immunology, Clin Microbiol Rev, 23, 1, pp. 74-98, (2010)
  • [7] Blanco J.C., Boukhvalova M.S., Shirey K.A., Prince G.A., Vogel S.N., New insights for development of a safe and protective RSV vaccine, Hum Vaccin, 6, 6, pp. 482-492, (2010)
  • [8] Johnson S., Oliver C., Prince G.A., Hemming V.G., Pfarr D.S., Wang S.C., Dormitzer M., O'Grady J., Koenig S., Tamura J.K., Development of a humanized monoclonal antibody (MEDI-493) with potent in vitro and in vivo activity against respiratory syncytial virus, J Infect Dis, 176, 5, pp. 1215-1224, (1997)
  • [9] Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants, Pediatrics, 102, 3, pp. 531-537, (1998)
  • [10] Feltes T.F., Cabalka A.K., Meissner H.C., Piazza F.M., Carlin D.A., Top Jr. F.H., Connor E.M., Sondheimer H.M., Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease, J Pediatr, 143, 4, pp. 532-540, (2003)
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