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Open Access Research article

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

Tatyana V Turti1*, Elena N Baibarina2, Elena A Degtiareva3, Elena S Keshishyan4, Yurii V Lobzin5, Leyla S Namazova-Вaranova1, Andrey P Prodeus6, Konstantin M Gudkov7, Anna I Kruglova7, Gregory A Schulz8 and Gerard F Notario8

Author Affiliations

1 Scientific Center of Children’s Health, RAMS, Lomonosovskiy Prospect, 2/62, Moscow, 119991, Russia

2 Center for Obstetrics, Gynecology, and Perinatology, Moscow, Russia

3 Peoples’ Friendship University of Russia, Moscow, Russia

4 Moscow Science Research Institute of Pediatrics and Pediatric Surgery, Moscow, Russia

5 Institute for Child Infections, St. Petersburg, Russia

6 Federal Scientific Clinical Center of Pediatric Hematology, Oncology, and Immunology, Moscow, Russia

7 Abbott, Moscow, Russia

8 Abbott, Abbott Park, IL, USA

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BMC Research Notes 2012, 5:484  doi:10.1186/1756-0500-5-484

Published: 4 September 2012

Abstract

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

Keywords:
Bronchopulmonary dysplasia; Congenital heart disease; Immunoprophylaxis; Lower respiratory tract infection; Preterm infant