Similarly, in an international study of children aged ≤24 months with hemodynamically significant congenital heart disease (HSCHD N = 1287), palivizumab prophylaxis resulted in a 45% reduction in RSV hospitalizations compared with placebo (5.3% vs 9.7%, respectively P = 0.003).
#Andrey prodeus trial#
A large (N = 1502), multicenter, randomized phase 3 trial conducted in the United States, Canada, and the United Kingdom showed that palivizumab prophylaxis reduced RSV-associated hospitalizations in preterm infants and children aged ≤24 months with BPD by 55% compared with placebo (4.8% vs 10.6%, respectively P = 0.00004). It has neutralizing activity in vitro and in vivo, and large clinical trials have demonstrated its efficacy and safety. Palivizumab (MedImmune, LLC, Gaithersburg, MD, and Abbott, Abbott Park, IL) is a humanized IgG1 monoclonal antibody specific for the F-glycoprotein on the RSV surface. Because of the lack of an effective vaccine and the presence of comorbidities, RSV prophylaxis by passive immunization is the primary intervention that can be administered to high-risk children to help prevent serious RSV disease. Further, RSV induces an atypical host immune response that fails to generate robust immunologic memory, leaving patients susceptible to reinfection. Supportive care is the main treatment strategy for serious LRTIs, as there is limited evidence of clinical benefit for the only US Food and Drug Administration − approved antiviral medication for RSV (ribavirin). Once infection is established, treatment options are limited. The virus infects airway epithelia and manifests as airway obstruction and increased airway resistance. Ĭhildren at high risk for serious RSV disease include preterm infants and those with cardiopulmonary illness, including congenital heart disease (CHD) and bronchopulmonary dysplasia (BPD). Activity peaked in April 2009, when RSV was detected in 62% of children hospitalized for LRTI. The prevalence of RSV varied by geographic region and was highest in Moscow (41.7%). In a sample of children aged ≤2 years who were hospitalized for LRTI during the RSV season, 38% tested positive for RSV. RSV infection is prevalent in the Russian Federation. In 2005, an estimated 33.8 million cases of RSV-associated LRTIs occurred worldwide in children aged <5 years, with at least 3.4 million resulting in hospitalization and 66,000–199,000 resulting in death. Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTIs) in children globally. Palivizumab was generally well tolerated and effectively prevented serious RSV infection in a mixed population of high-risk children in the Russian Federation. All other AEs were mild or moderate and considered not related/probably not related to palivizumab. Three non-serious AEs (acute intermittent rhinitis and rhinitis, 1 subject atopic dermatitis, 1 subject) were considered possibly related to palivizumab. Six of 7 subjects hospitalized for respiratory/cardiac conditions had an RSV test, which was negative in all cases. There were no RSV hospitalizations or deaths. One hundred subjects received ≥1 injection of palivizumab 94 completed their dosing schedule. Adverse events (AEs) were reported through 100 days following the final injection. The primary endpoint was RSV-related hospitalizations. 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. 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.
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.
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. No vaccine is currently approved for the prevention of RSV infection. 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).
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