Identification
- Summary
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.
- Brand Names
- Cnj-016
- Generic Name
- Human vaccinia virus immune globulin
- DrugBank Accession Number
- DB14112
- Background
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 Label,4. The IgG fraction is purified by the anion-exchange column chromatography method and the solution is solvent/detergent-treated to sterilize the compound 4. 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 4.
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 2,4.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Vaccines
Other vaccines - Synonyms
- Human vaccinia immune globulin
- Vaccinia immune globulin
- Vaccinia Immune Globulin (Human) Intravenous
- Vaccinia immune globulin intravenous (human)
- Vaccinia immunoglobulins
- VIG
Pharmacology
- Indication
CNJ-016 Vaccinia Immune Globulin Intravenous Human (VIGIV) is indicated for the treatment and/or modification of: (a) eczema vaccinatum, (b) progressive vaccinia, (c) severe generalized vaccinia, (d) vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions, or (e) aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard Label.
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Eczema vaccinatum •••••••••••• ••••••••• •••••• Treatment of Eczema vaccinatum •••••••••••• •••••• ••• •••• Treatment of Eczema vaccinatum •••••••••••• ••••• Treatment of Eczema vaccinatum •••••••••••• •••••••• Treatment of Eczema vaccinatum •••••••••••• •••• •••••••••• - Contraindications & Blackbox Warnings
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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) Label.
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 Label. 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 Label.
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 Label.
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 Label. 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 Label.
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 Label. This is consistent with the hypothesis that VIGIV can neutralize vaccinia virus in vivo Label. In addition, infusions of VIGIV of up to 24,000 U/kg were well tolerated Label.
- Mechanism of action
Intravenous human vaccinia virus immune globulin (VIGIV) provides passive immunity for individuals with complications to vaccinia virus vaccination. The exact mechanism of action, however, is not yet formally known Label.
Nevertheless, VIGIV is ultimately an isotonic sterile solution obtained by plasmaphoresis of individuals who were vaccinated prior with vaccinia virus and possess high anti-VACV antibody titers 1. The potency and effect of VIGIV is described by its ability to neutralize mature virus (MV, or intracellular mature virus, IMV) 1. Regardless, during an infection, various forms of infectious virions are generated 1. In particular, the MV is a more stable form of the virus and is considered to be the form that is transmitted from host-to-host 1. The other important form of the infectious virus is called the extracellular virus (EV, or extracellular enveloped virus, EEV), which is critical for the spread of the virus from cell-to-cell and to distant sites within a host 1. EV is subsequently an important element in pathogenesis 1. The major target of EV neutralizing antibody in VIGIV is against the EV-specific B5 protein 1. VIGIV also contains antibodies that react with viral encoded immune evasion molecules, which could also participate in VIGIV's anti-poxvirus activity 1. Researchers have begun to try to identify all of the VACV targets in VIGIV 1. Due to the highly homologous proteins encoded by orthopoxviruses, there is a high degree of shared serologic cross-reactivity 1. Thus VIGIV could react with proteins from other orthopoxviruses and have similar therapeutic effects against other poxvirus infections 1.
Ultimately, however, the most commonly held consideration regarding how VIGIV is capable of eliciting its therapeutic effect is the notion that such 'pre-generated' antibodies from individuals who have already been previously vaccinated with vaccinia virus, when administered to other people, may protect against VACV infections in these newly administered individuals in a method that is perhaps similar to the natural passive transfer of maternal antibodies from a mother to her baby 1.
- Absorption
In a phase 1, double-blind study with 60 healthy subjects randomized to receive either 6000 U/kg or 9000 U/kg of intravenous human vaccinia virus immune globulin (VIGIV), the mean peak plasma concentration after intravenous administration of 6000 U/kg to 31 healthy subjects was 161 U/mL achieved within 2 hours Label. Furthermore, after remaining in circulation for a prolonged period of time, maximum plasma concentrations (Cmax) of VIGIV reached levels ranging from about 160 to 232 U/mL Label.
- Volume of distribution
The volume of distribution was determined to be approximately 6630 mL Label.
- Protein binding
Readily accessible information regarding the protein binding of intravenous human vaccinia virus immune globulin (VIGIV) is not available.
- Metabolism
Readily accessible information regarding the metabolism of intravenous human vaccinia virus immune globulin (VIGIV) is not available.
- Route of elimination
Readily accessible information regarding the route oof elimination of vaccinia virus immune globulin (VIGIV) is not available.
- Half-life
The mean half-life was determined to be a range from approximately 26 to 30 days Label.
- Clearance
Readily accessible information regarding the clearance of intravenous human vaccinia virus immune globulin (VIGIV) is not available.
- Adverse Effects
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During clinical studies the most frequently reported adverse reactions included headache, nausea, rigors, and dizziness Label. Alternatively, although post-marketing experience has reported the following adverse reactions, the voluntary nature of their reporting means their frequency or possibility of causal relationships to use of the medication cannot be established reliably: infusion reactions (hypersensitivity including anaphylaxis, headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomforts, nausea, vomiting, rigors, back pain, myalgia, arthralgia, changes in blood pressure), renal reactions (acute renal dysfunction or failure, osmotic nephropathy), respiratory reactions (apnea, acute respiratory distress syndrome ARDS, TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm), cardiovascular reactions (cardiac arrest, thromboembolism, vascular collapse, hypotension), neurological reactions (coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome), integumentary reactions ( Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis)), hematologic reactions (pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs’) test), gastrointestinal reactions (hepatic dysfunction, abdominal pain), and pyrexia Label.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- No interactions found.
Products
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Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Cnj-016 Injection 1 [iU]/1mL Intravenous Emergent BioSolutions Canada Inc. 2005-05-01 Not applicable US 
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- 7UB4J759TD
- CAS number
- Not Available
References
- General References
- Xiao Y, Isaacs SN: Therapeutic Vaccines and Antibodies for Treatment of Orthopoxvirus Infections. Viruses. 2010 Oct;2(10):2381-2403. doi: 10.3390/v2102381. [Article]
- Hopkins RJ, Lane JM: Clinical efficacy of intramuscular vaccinia immune globulin: a literature review. Clin Infect Dis. 2004 Sep 15;39(6):819-26. doi: 10.1086/422999. Epub 2004 Aug 23. [Article]
- Koleba T, Ensom MH: Pharmacokinetics of intravenous immunoglobulin: a systematic review. Pharmacotherapy. 2006 Jun;26(6):813-27. doi: 10.1592/phco.26.6.813. [Article]
- Wittek R: Vaccinia immune globulin: current policies, preparedness, and product safety and efficacy. Int J Infect Dis. 2006 May;10(3):193-201. doi: 10.1016/j.ijid.2005.12.001. Epub 2006 Mar 27. [Article]
- External Links
- 597392
- Wikipedia
- Vaccinia_immune_globulin
- FDA label
- Download (201 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 2 Completed Treatment Vaccinia 1 Not Available Enrolling by Invitation Not Available Complication of Smallpox Vaccination 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Intravenous 1 [iU]/1mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at June 22, 2018 16:31 / Updated at July 18, 2023 22:57