CONTROLLED TRIAL TO EVALUATE PROTECTION OF HIGH-RISK INFANTS AGAINST RESPIRATORY SYNCYTIAL VIRUS-DISEASE BY USING STANDARD INTRAVENOUS IMMUNE GLOBULIN

We performed a randomized, controlled trial of intravenous immune glob ulin (respiratory syncytial virus RSV! neutralizing Nt! antibody tit er of 1:950 in 5% solution) to evaluate protection against RSV-induced disease over two respiratory virus seasons. Forty-nine children (mean age at enrollment, 4.5 months) with severe congenital heart disease o r bronchopulmonary dysplasia were randomized as follows. Twenty-four p atients were followed as controls and received no immune globulin. Twe nty-five patients received monthly infusions of immune globulin at a d ose of 500 mg/kg of body weight. There was a similar distribution betw een groups of patients with heart disease and bronchopulmonary dysplas ia. There were 12 culture-proven RSV infections, 6 in the prophylaxis group and 6 in the control group. There was a trend toward less severe RSV illness in immune globulin recipients, as measured by length of h ospitalization. Four of the six immune globulin recipients were hospit alized for a total of 35 days (mean, 8.8 +/- 5.0 days) because of RSV illness, in contrast to 51 hospital days (mean, 12.8 +/- 7.6 days) amo ng RSV-infected controls. We conclude that monthly infusions of standa rd immune globulin containing RSV Nt antibodies may be safely administ ered to high-risk children, but that standard intravenous immune globu lin does not contain sufficient RSV Nt antibody titer to fully protect against severe RSV illness.