BACKGROUND: Palivizumab reduces respiratory syncytial virus (RSV) hospitalisations in high-risk infants. Those with severe bronchopulmonary dysplasia may require two seasons of prophylaxis. There is concern that this humanised antibody might cause an adverse immune response in a second season of use. OBJECTIVE: To evaluate and compare the occurrence of anti-palivizumab antibodies and clinical adverse events in subjects receiving monthly palivizumab injections for a first and second season, and to assess frequency and severity of RSV disease in the two groups. DESIGN AND PATIENTS: Subjects aged <or=2 years at severe risk for RSV disease were designated as first season (no previous palivizumab exposure) or second season subjects (received palivizumab in previous RSV season). Palivizumab injections (15 mg/kg) were administered monthly for up to 5 months. Anti-palivizumab antibody titres and serum palivizumab concentrations were measured; adverse events were recorded. RESULTS: No first (n = 71) or second (n = 63) season subjects experienced a significant anti-palivizumab antibody response (titre >or=1 : 80). Serum palivizumab concentrations were similar for the two groups. Nine (12.7%) first season and 8 (12.7%) second season subjects experienced one or more serious adverse events; most were respiratory and all were considered to be not or probably not related to palivizumab. No deaths occurred during the study. CONCLUSIONS: Monthly palivizumab injections were not associated with adverse immune responses or adverse events in young children receiving palivizumab for one or two seasons. Children receiving palivizumab for a second season did not experience more severe adverse events than those receiving it for the first time.
BACKGROUND:Palivizumab reduces respiratory syncytial virus (RSV) hospitalisations in high-risk infants. Those with severe bronchopulmonary dysplasia may require two seasons of prophylaxis. There is concern that this humanised antibody might cause an adverse immune response in a second season of use. OBJECTIVE: To evaluate and compare the occurrence of anti-palivizumab antibodies and clinical adverse events in subjects receiving monthly palivizumab injections for a first and second season, and to assess frequency and severity of RSV disease in the two groups. DESIGN AND PATIENTS: Subjects aged <or=2 years at severe risk for RSV disease were designated as first season (no previous palivizumab exposure) or second season subjects (received palivizumab in previous RSV season). Palivizumab injections (15 mg/kg) were administered monthly for up to 5 months. Anti-palivizumab antibody titres and serum palivizumab concentrations were measured; adverse events were recorded. RESULTS: No first (n = 71) or second (n = 63) season subjects experienced a significant anti-palivizumab antibody response (titre >or=1 : 80). Serum palivizumab concentrations were similar for the two groups. Nine (12.7%) first season and 8 (12.7%) second season subjects experienced one or more serious adverse events; most were respiratory and all were considered to be not or probably not related to palivizumab. No deaths occurred during the study. CONCLUSIONS: Monthly palivizumab injections were not associated with adverse immune responses or adverse events in young children receiving palivizumab for one or two seasons. Children receiving palivizumab for a second season did not experience more severe adverse events than those receiving it for the first time.
Authors: B Law; N Macdonald; J Langley; I Mitchell; D Stephens; E Wang; J Robinson; F Boucher; J McDonald; S Dobson Journal: Paediatr Child Health Date: 1998-11 Impact factor: 2.253
Authors: S Johnson; C Oliver; G A Prince; V G Hemming; D S Pfarr; S C Wang; M Dormitzer; J O'Grady; S Koenig; J K Tamura; R Woods; G Bansal; D Couchenour; E Tsao; W C Hall; J F Young Journal: J Infect Dis Date: 1997-11 Impact factor: 5.226
Authors: K N Subramanian; L E Weisman; T Rhodes; R Ariagno; P J Sánchez; J Steichen; L B Givner; T L Jennings; F H Top; D Carlin; E Connor Journal: Pediatr Infect Dis J Date: 1998-02 Impact factor: 2.129