Serum Concentrations, Efficacy, and Safety of a New, Intravenously Administered Varicella Zoster Immune Globulin in Pregnant Women

Authors

  • Gideon Koren MD,

    Corresponding author
    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Deborah Money MD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Marc Boucher MD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Fred Aoki MD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Martin Petric PhD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Gilda Innocencion Bsc,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Michael Woloski PhD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Valencia Remple,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Francine Pelland,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Ruth Geist MD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Tommy Ho MD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Benny Bar-Oz MD,

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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  • Ronen Loebstein MD

    1. Motherisk Program, Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children and the Department of Paediatrics, The Leadership Initiative in Better Pharmacotherapy During Pregnancy and Lactation
    2. Departments of Obstetrics & Gynecology, Hǒpital St. Justine, Université de Montreal
    3. Department of Medical Microbiology, University of Winnipeg; and BC Women's Health Centre, Vancouver.
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Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8.

Abstract

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.

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