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01-04-2003 | Original Research Article

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

Authors: Thierry Lacaze-Masmonteil, Juergen Seidenberg, Ian Mitchell, Veerle Cossey, Martin Cihar, Michal Csader, Rienk Baarsma, Marques Valido, Paul F. Pollack, Dr Jessie R. Groothuis

Published in: Drug Safety | Issue 4/2003

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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Hall CB. Respiratory syncytial virus. In: Feigin RD, Cherry JD, editors. Textbook of pediatric infectious diseases. Philadelphia (PA): Saunders, 1998: 2084–111

Shay DK, Holman RC, Newman RD, et al. Bronchiolitis-associated hospitalizations among US children, 1980-1996. JAMA 1999 Oct 20; 282(15): 1440–6PubMedCrossRef

Hall CB, McCarthy CA. Respiratory syncytial virus. In: Mandell GL, Bennett JE, Dolin R, editors. Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 4th ed. New York (NY): Churchill Livingstone, 1995: 1501–19

Groothuis JR, Salbenblatt CK, Lauer BA. Severe respiratory syncytial virus infection in older children. Am J Dis Child 1990 Mar; 144(3): 346–8PubMed

Groothuis JR, Gutierrez KM, Lauer BA. Respiratory syncytial virus infection in children with bronchopulmonary dysplasia. Pediatrics 1988 Aug; 82(2): 199–203PubMed

Boyce TG, Mellen BG, Mitchel EF, et al. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr 2000 Dec; 137(6): 865–70PubMedCrossRef

Hall CB, Powell KR, Schnabel KC, et al. Risk of secondary bacterial infection in infants hospitalized with respiratory syncytial virus infection. J Pediatr 1988 Aug; 113(2): 266–71PubMedCrossRef

MacDonald NE, Hall CB, Suffin SC, et al. Respiratory syncytial virus infection in infants with congenital heart disease. N Engl J Med 1982 Aug; 307(7): 397–400PubMedCrossRef

Piedra PA. Respiratory syncytial virus vaccines: recent developments. Pediatr Infect Dis J 2000 Aug; 19(8): 805–8PubMedCrossRef

10.

Johnson S, Oliver C, Prince GA, et al. Development of a humanized monoclonal antibody (MEDI-493) with potent in vitro and in vivo activity against respiratory syncytial virus. J Infect Dis 1997 Nov; 176(5): 1215–24PubMedCrossRef

11.

The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 1998 Sep; 102 (3 Pt 1): 531–7

12.

American Academy of Pediatrics Committee on Infectious Diseases. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics 1998 Nov; 102 (5): 1211–6

13.

Carbonell-Estraney X, Giuffré L, Kimpen JLL, et al. Guidelines for the use of Synagis® (palivizumab), a humanized monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) disease in high-risk infants: a consensus opinion. Infect Med 1999 Dec; 16Suppl. G: 29–33

14.

ICH Harmonized Tripartite Guideline for Good Clinical Practice (E6). International Conference on Harmonization Website. Available from URL: http://www.ifpma.org/ich5e.html#GCP [Accessed 1999 Sep 10]

15.

Gardner PS, McQuillin J. Rapid virus diagnosis. 2nd ed. London: Butterworth and Co Ltd, 1980

16.

Hall CB, Douglass Jr RG. Clinically useful method for the isolation of respiratory syncytial virus. J Infect Dis 1975 Jan; 131(1): 1–5PubMedCrossRef

17.

Mcintosh K, Hendry RM, Fahnestock ML, et al. Enzyme-linked immunosorbent assay for detection of respiratory syncytial virus infection: application to clinical samples. J Clin Microbiol 1982 Aug; 16(2): 329–33PubMed

18.

Subramanian KNS, Weisman LE, Rhodes T, et al. Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. Pediatr Infect Dis J 1998; 17 (2): 110–5

19.

Null DM, Connor EM. Evaluation of immunogenicity and safety in children receiving palivizumab for a second RSV season [abstract]. Pediatr Res 1999; 45(Pt 2 of 2): 170ACrossRef

20.

Gross R. Analytical report, evaluation of MEDI-493. Immunogenicity in children (a phase II/IV multicenter study, W99-310). MedImmune Jun 2001. (Data on file)

21.

Abman SH, Groothuis JR. Pathophysiology and treatment of bronchopulmonary dysplasia: current issues. Pediatr Clin North Am 1994 Apr; 41(2): 277–315PubMed

22.

Cavalier S, Escobar GJ, Fernbach SA, et al. Postdischarge utilization of medical services by high-risk infants: experience in a large managed care organization. Pediatarics 1996 May; 97(5): 693–9

23.

Parker RA, Lindstrom DP, Cotton RB. Improved survival accounts for most, but not all, of the increase in bronchopulmonary dysplasia. Pediatrics 1992 Nov; 90(5): 663–8PubMed

24.

Law BJ, MacDonald N, Langley J, et al. Severe respiratory syncytial virus infection among otherwise healthy prematurely born infants: what are we trying to prevent? J Paediatr Child Health 1998 Nov/Dec; 3(6): 402–4

Title: Evaluation of the Safety of Palivizumab in the Second Season of Exposure in Young Children at Risk for Severe Respiratory Syncytial Virus Infection
Authors: Thierry Lacaze-Masmonteil
Juergen Seidenberg
Ian Mitchell
Veerle Cossey
Martin Cihar
Michal Csader
Rienk Baarsma
Marques Valido
Paul F. Pollack
Dr Jessie R. Groothuis
Publication date: 01-04-2003
Publisher: Springer International Publishing
Published in: Drug Safety / Issue 4/2003
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.2165/00002018-200326040-00005

At a glance: The STEP trials

Springer Medicine

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

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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