title: Safety and bioequivalency of three formulations of respiratory syncytial virus-enriched immunoglobulin.
abstract: Respiratory syncytial virus (RSV) causes serious illness (lower respiratory illness) in preterm infants. RSV antibody-enriched immunoglobulin (RSVIG) that was lyophilized (LYO) protected against RSV lower respiratory illness. The Food and Drug Administration now requires an additional viral inactivation step (VI). We compared LYO, LYO-VI, and a more convenient liquid RSVIG (LIQ-VI) in 30 preterm infants (median age, 7 months; median weight, 5.4 kg). Infants were randomized to receive LYO (n = 10), LYO-VI (n = 10), or LIQ-VI (n = 10) in monthly infusions of 750 mg/kg of body weight per dose (December to March). Children were monitored closely for adverse reactions to RSVIG and for RSV illness.
authors.affiliation: Department of Pediatrics, University of Colorado School of Medicine, Denver, USA.
authors.forename: J R
authors.initials: JR
authors.lastname: Groothuis
authors.forename: E A
authors.initials: EA
authors.lastname: Simoes
authors.forename: M V
authors.initials: MV
authors.lastname: Lehr
authors.forename: A A
authors.initials: AA
authors.lastname: Kramer
authors.forename: V G
authors.initials: VG
authors.lastname: Hemming
authors.forename: W J
authors.initials: WJ
authors.lastname: Rodriguez
authors.forename: J
authors.initials: J
authors.lastname: Arrobio
authors.forename: R C
authors.initials: RC
authors.lastname: Welliver
authors.forename: G R
authors.initials: GR
authors.lastname: Siber
mesh_terms: D004311:Double-Blind Method; D006207:Half-Life; D006801:Humans; D007136:Immunoglobulins / Q000009:adverse effects* / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000517:prevention & control; D018113:Respiratory Syncytial Virus, Human / Q000276:immunology*; D013810:Therapeutic Equivalency
chemical_list: D007136:Immunoglobulins