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Research Letter |

Outcomes of Respiratory Syncytial Virus Immunoprophylaxis in Infants Using an Abbreviated Dosing Regimen of Palivizumab

Pascal M. Lavoie, MDCM, PhD, FRCPC1,2,3; Alfonso Solimano, MD, FRCPC1,3; Richard Taylor, MBBS, FRCPC4; Eddie Kwan, PhD1,5; Jennifer Claydon, MSc1; Stuart E. Turvey, MBBS, DPhil, FRCPC1,2,6; Nico Marr, PhD1,7,8
[+] Author Affiliations
1Children’s & Women’s Health Centre of British Columbia, University of British Columbia, Vancouver
2Child & Family Research Institute, Vancouver, British Columbia
3Division of Neonatology, Department of Pediatrics, University of British Columbia, Vancouver
4Department of Pediatrics, University of Victoria, Victoria, British Columbia
5Department of Pharmacy, University of British Columbia, Vancouver
6Division of Allergy and Clinical Immunology, University of British Columbia, Vancouver
7Canadian Center for Vaccinology, Halifax, Nova Scotia
8Sidra Medical and Research Center, Doha, Qatar
JAMA Pediatr. 2016;170(2):174-176. doi:10.1001/jamapediatrics.2015.3235.
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This study details the experience of using an abbreviated palivizumab dosing schedule in infants at higher risk for respiratory syncytial virus hospitalization.

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections in infants younger than 1 year. Premature infants, infants with chronic lung disease, infants with major congenital heart diseases, or infants with severe immunodeficiencies are at highest risk of hospital admission for RSV. Palivizumab, a monoclonal antibody, reduces pulmonary viral replication by 100-fold at serum drug levels greater than 40 μg/mL in the cotton rat model.1 On the basis of randomized clinical trials, monthly administration of 15 mg/kg of palivizumab reduces hospitalizations by approximately 55% in these infants.2 However, the costliness of this drug restrains its broader use. The American Academy of Pediatrics recommends a maximum of 5 palivizumab doses in selected risk groups during the RSV season,2 although pharmacokinetic analyses suggest that equivalent antibody protection may be sustainably achieved with fewer doses.3,4

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Serum Respiratory Syncytial Virus (RSV) Neutralizing Antibody Titers in Infants in the Abbreviated Palivizumab Dosing Program

A subset of infants approved to receive either 3 or 4 doses of palivizumab were tested before any palivizumab dose, between 1 and 5 days after a first dose of palivizumab, and at the end of the RSV season (at least 30 days after the last palivizumab dose or after April 15, whichever came last). The RSV neutralizing antibody titers were also determined in season-matched healthy adults. The RSV neutralizing serum antibody titer equivalents (NT95) are based on the ability of a serum dilution (expressed as 1/titer) to inhibit 95% or more of viral infection. In this assay, we determined that palivizumab serum concentrations of 40 μg/mL correspond to a median neutralizing antibody titer of 1:12 (dotted line with minimum and maximum values [shaded area from 3 independent experiments performed in duplicate]). Detection limit was NT95 of approximately 4 (or 1/4), equivalent to a serum concentration of palivizumab of approximately 6.25 μg/mL except for predose serum samples for which the detection limit of the assay was NT95 of approximately 2. Error bars represent median with interquartile range.

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