Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Motavizumab, a Humanized, Enhanced-Potency Monoclonal Antibody for the Prevention of Respiratory Syncytial Virus Infection in At-Risk Children

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dc.contributor.authorAbarca, Katia
dc.contributor.authorJung, Elizabeth
dc.contributor.authorFernandez, Pilar
dc.contributor.authorZhao, Liang
dc.contributor.authorHarris, Brian
dc.contributor.authorConnor, Edward M.
dc.contributor.authorLosonsky, Genevieve A.
dc.contributor.authorMotavizumab Study Grp
dc.date.accessioned2024-01-10T14:21:36Z
dc.date.available2024-01-10T14:21:36Z
dc.date.issued2009
dc.description.abstractBackground: Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection in young children. Motavizumab is an investigational humanized monoclonal antibody for RSV prophylaxis.
dc.description.abstractMethods: A dose-escalation study was conducted followed by assessment of safety, tolerability, serum concentrations, and immunogenicity during a second consecutive RSV season. In season 1, premature infants aged <= 6 months or children <= 24 months with chronic lung disease of prematurity received monthly motavizumab (3 or 15 mg/kg). In season 2, children who received >= 3 motavizumab doses in season 1 were randomized to receive monthly motavizumab or palivizumab 15 mg/kg.
dc.description.abstractResults: Of 217 children enrolled in season 1, 211 (97.2%) received motavizumab 15 mg/kg and 205 (94.5%) patients completed the study through 90 days after the final dose. In season 2, 136 children were randomized to receive motavizumab (n = 66) or palivizumab (n = 70). The most commonly reported related adverse event was transient injection site erythema. In season 1, mean trough motavizumab concentrations were 7.9 and 50.2 mu g/mL after the 3- and 15-mg/kg doses, respectively. Trough concentrations increased with repeated motavizumab dosing; a similar pattern was seen in season 2. Antimotavizumab reactivity occurred infrequently (3.3%) in season 1. In season 2, no treatment group-specific antidrug antibody was detected through 90 to 120 days after dosing with either product.
dc.description.abstractConclusions: The pharmacokinetic profile of motavizumab was similar to that of other IgG(1) antibodies. Increased adverse reactions or immunogenicity were not observed during and after a second season of treatment with motavizumab. Safety findings from these studies supported the continued development of motavizumab.
dc.description.funderMedImmune
dc.fechaingreso.objetodigital2024-05-22
dc.format.extent6 páginas
dc.fuente.origenWOS
dc.identifier.doi10.1097/INF.0b013e31818ffd03
dc.identifier.eissn1532-0987
dc.identifier.issn0891-3668
dc.identifier.pubmedidMEDLINE:19258920
dc.identifier.urihttps://doi.org/10.1097/INF.0b013e31818ffd03
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/79722
dc.identifier.wosidWOS:000264603600002
dc.information.autorucMedicina;Abarca K ;S/I;70281
dc.issue.numero4
dc.language.isoen
dc.nota.accesocontenido parcial
dc.pagina.final272
dc.pagina.inicio267
dc.publisherLIPPINCOTT WILLIAMS & WILKINS
dc.revistaPEDIATRIC INFECTIOUS DISEASE JOURNAL
dc.rightsacceso restringido
dc.subjectclinical trial
dc.subjectmotavizumab
dc.subjectpalivizumab
dc.subjectpediatric
dc.subjectrespiratory syncytial virus
dc.subjectPREMATURE-INFANTS
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleSafety, Tolerability, Pharmacokinetics, and Immunogenicity of Motavizumab, a Humanized, Enhanced-Potency Monoclonal Antibody for the Prevention of Respiratory Syncytial Virus Infection in At-Risk Children
dc.typeartículo
dc.volumen28
sipa.codpersvinculados70281
sipa.indexWOS
sipa.indexScopus
sipa.trazabilidadCarga SIPA;09-01-2024
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