TY - JOUR
T1 - Serum concentrations, efficacy, and safety of a new, intravenously administered varicella zoster immune globulin in pregnant women
AU - Koren, Gideon
AU - Money, Deborah
AU - Boucher, Marc
AU - Aoki, Fred
AU - Petric, Martin
AU - Innocencion, Gilda
AU - Woloski, Michael
AU - Remple, Valencia
AU - Pelland, Francine
AU - Geist, Ruth
AU - Ho, Tommy
AU - Bar-Oz, Benny
AU - Loebstein, Ronen
PY - 2002
Y1 - 2002
N2 - Chickenpox is teratogenic in humans, and varicella zoster immune globulin (VZIG) is given to pregnant women believed to be susceptible to the virus after contact with chickenpox. Available VZIG is given as intramuscular injections. The objective of this study was to evaluate the efficacy, safety, and serum concentrations of a new VZIG that can be given intravenously. The new VZIG (Cangene Pharm., Inc.) was compared to the standard VZIG (Massachusetts Public Health Biologic Laboratories) in a randomized protocol in 57 pregnant women seronegative to varicella zoster virus (VZV). Pregnant women received 125 units per units per 10 kg bodyweight to a maximal dose of 625 units. Women were evaluated on days 2, 7, 14, and 28 and at other times if symptoms developed into clinical varicella, which was scored by the Constitutional Illness Score. The new VZIG was comparable to the standard VZIG on all parameters of efficacy and safety. Levels of VZV antibodies at day 2 postinjection were significantly higher among those receiving the new preparation intravenously. The authors concluded that the new intravenous form of VZIG confers higher initial levels of VZV antibodies and is comparable in terms of its maternal efficacy and safety to the standard form of VZIG.
AB - Chickenpox is teratogenic in humans, and varicella zoster immune globulin (VZIG) is given to pregnant women believed to be susceptible to the virus after contact with chickenpox. Available VZIG is given as intramuscular injections. The objective of this study was to evaluate the efficacy, safety, and serum concentrations of a new VZIG that can be given intravenously. The new VZIG (Cangene Pharm., Inc.) was compared to the standard VZIG (Massachusetts Public Health Biologic Laboratories) in a randomized protocol in 57 pregnant women seronegative to varicella zoster virus (VZV). Pregnant women received 125 units per units per 10 kg bodyweight to a maximal dose of 625 units. Women were evaluated on days 2, 7, 14, and 28 and at other times if symptoms developed into clinical varicella, which was scored by the Constitutional Illness Score. The new VZIG was comparable to the standard VZIG on all parameters of efficacy and safety. Levels of VZV antibodies at day 2 postinjection were significantly higher among those receiving the new preparation intravenously. The authors concluded that the new intravenous form of VZIG confers higher initial levels of VZV antibodies and is comparable in terms of its maternal efficacy and safety to the standard form of VZIG.
UR - http://www.scopus.com/inward/record.url?scp=18244362059&partnerID=8YFLogxK
U2 - 10.1177/00912700222011283
DO - 10.1177/00912700222011283
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C2 - 11865962
AN - SCOPUS:18244362059
SN - 0091-2700
VL - 42
SP - 267
EP - 274
JO - Journal of Clinical Pharmacology
JF - Journal of Clinical Pharmacology
IS - 3
ER -