Human vaccinia virus immune globulin

Specification

• Cat#: THA-0109
• Product Name: Human vaccinia virus immune globulin
• Description: Human vaccinia virus immune globulin is a purified gamma globulin used to treat vaccinia infections where skin is compromised, or infections of the eyes, mouth, or other areas where vaccinia infections present a special hazard.
• Introduction: Human vaccinia immune globulin (VIG) is a sterile solution containing the purified gamma globulin (IgG) fraction of plasma taken from healthy donors previously vaccinated with live vaccinia virus vaccine who possess high titers of anti-vaccinia virus antibody. The IgG fraction is purified by the anion-exchange column chromatography method and the solution is solvent/detergent-treated to sterilize the compound. Most compounds used currently are intravenous formulations, which contain no preservatives-unlike prior intramuscular compounds which contained thiomersal, a mercury derivative preservative that could be potentially teratogenic. Nevertheless, VIG by virtue of the way it is produced is a poorly characterized and highly variable human product that is only available in very limited quantities-all factors that may intervene with its availability and effectiveness.
• Purity: >99% by SDS-Page and HPLC analysis
• Appearance: Not Available

Pharmaceutical Information

• Pharmacodynamics: In two phase 2, double-blind pharmacodynamic studies, 82 healthy volunteers were randomized to receive vaccinia vaccination with or without Vaccinia Immune Globulin Intravenous (Human) (VIGIV). In the first study, the efficacy of 9000 U/kg of VIGIV on the immunologic and local response to the freeze-dried calf lymph smallpox vaccine Dryvax was evaluated. A total of 32 healthy subjects were randomized to receive single IV infusions of either VIGIV (9,000 U/kg) or placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either placebo or VIGIV (9,000 U/kg) concurrently with vaccinia (Dryvax) vaccination on Day 4. In the second study, 50 healthy subjects were randomized to receive a single IV infusion of either VIGIV (9,000 U/kg), VIGIV (24,000 U/kg), or placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either placebo or vaccinia (Dryvax) vaccination on Day 4. The effect of VIGIV on the immunologic response to Dryvax was determined by measuring vaccinia antibody titer (vaccinia IgG) in plasma and comparing titer levels across all three treatment arms. In addition, the effect of VIGIV on the local response (tissue) to Dryvax was assessed by evaluating the size of the pox reaction, as well as the area of erythema and induration following vaccination. VIGIV (9,000 U/kg and 24,000 U/kg) reduced the local and immunological response to vaccinia vaccination when it was administered 4 days prior to vaccination compared to vaccination alone. This is consistent with the hypothesis that VIGIV can neutralize vaccinia virus in vivo. In addition, infusions of VIGIV of up to 24,000 U/kg were well tolerated.