Serum concentrations, efficacy, and safety of a new, intravenously administered varicella zoster immune globulin in pregnant women.
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 10 kg body weight 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.
Koren
Gideon
G
Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, Toronto, Ontario.
Money
Deborah
D
Boucher
Marc
M
Aoki
Fred
F
Petric
Martin
M
Innocencion
Gilda
G
Wolosk
Michael
M
Remple
Valencia
V
Pelland
Francine
F
Geist
Ruth
R
Ho
Tommy
T
Bar-Oz
Benny
B
Loebstein
Ronen
R
D000328:Adult; D000704:Analysis of Variance; D000914:Antibodies, Viral / Q000097:blood; D002644:Chickenpox / Q000097:blood / Q000517:prevention & control / Q000821:virology; D005260:Female; D014645:Herpesvirus 3, Human / Q000276:immunology*; D006801:Humans; D007106:Immune Sera / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood*; D007116:Immunization, Passive / Q000379:methods* / Q000706:statistics & numerical data; D007262:Infusions, Intravenous; D007273:Injections, Intramuscular; D008875:Middle Aged; D011247:Pregnancy; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric
D000914:Antibodies, Viral; D007106:Immune Sera; C030799:varicella-zoster immune globulin