Safety and bioequivalency of three formulations of respiratory syncytial virus-enriched immunoglobulin.
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.
Groothuis
J R
JR
Department of Pediatrics, University of Colorado School of Medicine, Denver, USA.
Simoes
E A
EA
Lehr
M V
MV
Kramer
A A
AA
Hemming
V G
VG
Rodriguez
W J
WJ
Arrobio
J
J
Welliver
R C
RC
Siber
G R
GR
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
D007136:Immunoglobulins