Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain
the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in
Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles
and JavaScript.
The American Pediatric Society and the Society for Pediatric Research 1999 Abstract
Published:
Safety and Pharmacokinetics of Intravenous Varicella Zoster Hyperimmune Globulin (IV-VZIG) in Newborns, and Analysis of Maternal Varicella History as a Predictor of Varicella Immune Status
INTRODUCTION. An IV-VZIG preparation (VaritectR, Biotest Pharma, Germany), currently approved for use in several countries in Europe and Asia, was used in high risk newborns(nb). No previous studies of safety and pharmacokinetics of this preparation in nb have been published. Current practice establishes that maternal varicella immune status guides VZV (varicella zoster virus) prophylaxis in nb at risk for varicella. OBJECTIVES. 1. Assess safety and pharmacokinetics of an IV-VZIG preparation in nb. 2. Determine the accuracy of the mother's history of varicella as a predictor of maternal serologic immune status to VZV in this population. METHODS. 18 infants (12 PT, 6T) at risk for varicella were given IV-VZIG, 25IU (1ml)/kg (as recommended by the manufacturer). Serum VZ-IgG titers were determined on all mothers, and nb at 0,1,7,14,21,28 and 35 days post VZIG infusion; serum VZ-IgM titers were determined on nb at 4 weeks postinfusion. VZ-Ig titers were measured by ELISA (Dr Arvin's lab). Head ultrasound, renal and liver function tests, blood cell count and urinalysis were obtained before and within 48hs of IV-VZIG infusion. The sensitivity (ss), specificity (sp), positive (p+) and negative (p-) predictive values of the history of maternal varicella to determine VZV immune status were evaluated. RESULTS. One infant developed a skin rash at the end of the VZIG infusion, but subsided rapidly. No other side effects occurred. VZ-IgM titers were negative on all infants. The mean VZ-IgG titers at selected times are shown on the table; mean VZ-IgG titers pre and 1d post IV-VZIG were similar, however 4/18 (22%) infants had a 2-8 fold increase over the basal titers. A 28 weeker had a basal reciprocal log VZ-IgG titer of 3.01. The ss, sp, p+ and p-, of maternal history of varicella to predict their immune status to VZV were 78%, 50%, 84% and 40%, respectively. CONCLUSIONS. The IV infusion of VZIG was safe in this population. Only 22% of the IV-VZIG recipients had a measurable increase in serum VZ-IgG titers. A 28 weeker had a high basal VZ-IgG titer. The history of maternal clinical varicella was not a reliable indicator of VZ-specific serologic status in our population. IMPLICATIONS. A measurable increase over basal VZ titers was not observed in most patients who received 25IU/kg of IV-VZIG and who already had passive VZ-specific antibodies. This finding may not necessarily apply to seronegative infants.
Murguia-De Sierra, T., Molina-Leon, A., Villa-Guillen, M. et al. Safety and Pharmacokinetics of Intravenous Varicella Zoster Hyperimmune Globulin (IV-VZIG) in Newborns, and Analysis of Maternal Varicella History as a Predictor of Varicella Immune Status.
Pediatr Res45, 271 (1999). https://doi.org/10.1203/00006450-199904020-01614
