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

Abstract

BackgroundRespiratory 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.ResultsOne 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.ConclusionPalivizumab was generally well tolerated and effectively prevented serious RSV infection in a mixed population of high-risk children in the Russian Federation.Trial registrationClinicalTrials.gov: NCT01006629

Safety and Effectiveness of Palivizumab in Children at High Risk of Serious Disease Due to Respiratory Syncytial Virus Infection: A Systematic Review

“…Prior to palivizumab approval in the Russian Federation, a multicenter, prospective, open-label, non-comparative clinical study (ClinicalTrials.gov #NCT01006629) was conducted in high-risk children [ 40 ]. The study included children at high risk of serious RSV disease, defined as infants born at ≤35 weeks GA who were ≤6 months old at enrollment or children ≤24 months old with a clinical diagnosis of BPD and/or hemodynamically significant CHD.…”

Seasonal immune modulation in humans: Observed patterns and potential environmental drivers

“…65,66 In this temperate setting, respiratory infections are most common in late winter/early spring. 67,68 While improved viral survival due to the low winter temperatures in temperate settings is one plausible driver of this seasonal variation in respiratory infections, reduced immune competence during the winter may also play a role in driving the observed seasonality of respiratory infections.…”

Immunoptophylaxis of the Respiratory Syncytial Viral Infection in Children Under Risk of Heavy Course of the Disease: Preliminary Results of Implementing the Moscow Program

“…Кроме того, накапливается все больше сведений о возможном снижении риска развития бронхиальной астмы в отдаленном периоде при использовании данного препарата у детей из групп риска [28]. Небольшой отечественный опыт иммунопрофилактики паливизумабом подтвердил эффективность и безопасность препарата [29,30]. В 2011 г. Департаментом здравоохранения города Москвы было принято решение о проведении целенаправленной иммунопрофилактики РСВ-инфекции у детей групп высокого риска (глубоконедоношенных детей с БЛД и детей первых месяцев жизни с врожденными пороками сердца), родившихся в лечебно-профилактических учреждениях города Москвы.…”

“…Таким образом, паливизумаб в данном исследовании, как и в ранних отечественных и крупных иссле- до ваниях других стран [29,30], продемонстрировал свою эффективность в отношении снижения частоты ИНДП и госпитализаций в связи с ними у детей групп риска, а также в предотвращении ИНДП РСВ-этиоло гии. Это особенно важно в связи с высокой потребностью таких пациентов в стационарном лечении, интенсивной и оксигенотерапии при развитии ИНДП, как было указано ранее (см.…”