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Evaluation of the Safety of Palivizumab in the Second Season of Exposure in Young Children at Risk for Severe Respiratory Syncytial Virus Infection

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Abstract

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 ≤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 ≥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.

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Acknowledgments

This study was supported by Abbott Laboratories. We thank Jacky Wu, Ph.D. and Stacy Simpson for their assistance in writing and editing the manuscript, Dr. Randy Tressler for contributions to the protocol design, and Maggie McCue and Michelle Keefe for assistance in preparation of the manuscript.

Jessie van Groothuis and Paul Pollack are employed by Abbott Laboratories. Professor Lacaze-Masmonteil has spoken at an Abbott-sponsored symposium, for which he received an honorarium. To our knowledge, the remainder of the authors and study participants have no further conflict of interest, other than their participation in this (and possibly other) Abbott-sponsored study.

In addition to the authors, the following individuals participated in this study: Karel Allegaert (UZ Gasthuisberg, Leuven, Belgium); Jacques Lombet (Centre Hospitalier Régional de la Citadelle, Liège, Belgium); Dominique Haumont and Katleen Plaskie (Hôpital Universitaire St. Pierre, Brussels, Belgium); H. Dele Davies (Alberta Children’s Hospital, Calgary, Canada); Reginald S. Sauve (University of Calgary, Alberta, Canada); Joanne M. Langley (Izaak Walton Killam Grace Health Center, Dalhousie University, Halifax, Nova Scotia, Canada); Karel Liska (Charles University, Prague, Czech Republic).; Patrick Andre (Hôpital Antoine Béclère, Clamart, France); Pierre Lequien, Nadine Kacet, and Fabrice Lapeyre (Hôpital Jeanne de Flandre, CHRU Lille, France); Barbara Wickenburg-Ennen, Helga Nolte, and Peter Andreas Harding (Elisabeth-Kinderkrankenhaus, Oldenburg, Germany); Sandra Ramos and Margarida Carolino (Hospital St. António, Porto, Portugal); and Antónia Marques (Maternidade Dr. Alfredo da Costa, Lisbon, Portugal).

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Correspondence to Jessie R. Groothuis.

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Lacaze-Masmonteil, T., Seidenberg, J., Mitchell, I. et al. Evaluation of the Safety of Palivizumab in the Second Season of Exposure in Young Children at Risk for Severe Respiratory Syncytial Virus Infection. Drug-Safety 26, 283–291 (2003). https://doi.org/10.2165/00002018-200326040-00005

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  • DOI: https://doi.org/10.2165/00002018-200326040-00005

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