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A phase 1, randomized, double-blind study was conducted in which 60 healthy volunteers received either 6000 U/kg or 9000 U/kg VIGIV (vaccinia immune globulin intravenous) .4 After intravenous administration of 6000 U/kg to 31 healthy male and female volunteers, a mean peak plasma concentration of 161 U/mL was achieved within 2 hours. The half-life of VIGIV (vaccinia immune globulin intravenous) was 30 days (range of 13 to 67 days) and the volume of distribution was 6630 L. Pharmacokinetic parameters were calculated based on antibody levels determined by an ELISA.
The binding capacity and neutralizing antibody activity of anti-vaccinia antibody in these subjects 5 days after intravenous administration of VIGIV (vaccinia immune globulin intravenous) 4 (both 6000 U/kg and 9000 U/kg dosages) were at least as high as the theoretical values that would be achieved following the administration of the comparator Vaccinia Immune Globulin (VIG) (see Table 2). Five days represents the approximate time of peak serum anti-vaccinia antibody concentration following intramuscular administration of other Immune Globulin (Human) products. No historical pharmacokinetic data are available for the theoretical intramuscular comparator, Vaccinia Immune Globulin (VIG). 5 Nor are there any pharmacodynamic or efficacy data from controlled trials available for any VIG IM/IV product.
Table 2: Test of Non-inferiority5
|Dose VIGIV, U/kg||Plasma levels, U/mL (Range*)||Ratio of Means %
|6000||60.1 (36.1-84.6)||66.2 (42.3-94.9)||90.82 (86.94)|
|9000||90.3 (63.4-133.8)||64.8 (47.6-87.2)||139.40 (135.27)|
|*geometric mean (range)
*** simulated levels
**** expressed as a percentage relative to the geometric mean of the simulated concentrations at Day 5 after 6000 U/kg intramuscular administration
A pilot phase 1 double blind pharmacodynamic study was conducted in which 32 healthy volunteers were randomized to receive vaccinia vaccination with or without VIGIV (vaccinia immune globulin intravenous) . The objectives of the study were to assess the effects of VIGIV (vaccinia immune globulin intravenous) upon the local and immunological response to vaccinia vaccination and to further characterize the safety of VIGIV (vaccinia immune globulin intravenous) . When VIGIV (vaccinia immune globulin intravenous) was administered prior to or concurrently with vaccinia vaccination, the safety profile of VIGIV (vaccinia immune globulin intravenous) was consistent with the pharmacokinetic study.
Ongoing clinical studies are further evaluating the effects of concurrent administration of VIGIV (vaccinia immune globulin intravenous) with vaccinia vaccine on the pharmacokinetics of the vaccine-induced antibody response, on local vaccination site reaction, and on safety.
4. Unpublished data on file, VA-002 Final Study Report, Cangene Corporation.
5. Unpublished data on file, VA-002 Addendum Report, Cangene Corporation.
Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.
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