Safety and bioequivalency of three formulations of respiratory syncytial virus-enriched immunoglobulin

Antimicrob Agents Chemother. 1995 Mar;39(3):668-71. doi: 10.1128/AAC.39.3.668.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Double-Blind Method
  • Half-Life
  • Humans
  • Immunoglobulins / adverse effects*
  • Immunoglobulins / therapeutic use*
  • Infant
  • Infant, Newborn
  • Infant, Premature
  • Prospective Studies
  • Respiratory Syncytial Virus Infections / prevention & control
  • Respiratory Syncytial Virus, Human / immunology*
  • Therapeutic Equivalency

Substances

  • Immunoglobulins