VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

Study Overview
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Brief Summary
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This is a post-marketing study to verify the clinical benefits of VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] in the resolution of complications resulting from smallpox vaccination in eligible patients treated with VIGIV.

Detailed Description
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This is an open-label Phase 4 study designed to collect additional data to assess the safety and efficacy of VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] in the first 100 consented patients treated with VIGIV.

Official Title
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Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

Conditions
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Complication of Smallpox Vaccination

Intervention / Treatment
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* Biological: VIGIV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions: Eczema vaccinatum. Progressive vaccinia. Severe generalized vaccinia. 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. 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. Informed consent voluntarily signed by subject, legal guardian or representative to participate in the study. For minors, the informed consent form must be signed by a legally acceptable representative and when appropriate, informed consent/assent must also be obtained from the minor. Exclusion Criteria: None.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects treated with VIGIV.<br>Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions: Eczema vaccinatum. Progressive vaccinia. Severe generalized vaccinia. Vaccinia infections in individuals who have skin conditions. Aberrant infections induced by vaccinia virus (except in cases of isolated keratitis). | Biological: VIGIV<br>* VIGIV is licensed in US, by the FDA, for the treatment of complications of smallpox vaccinations and is available to eligible patients regardless of participation in this study.<br>* Other names: Vaccinia Immune Globulin Intravenous (Human);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of vaccinia infection complications |  | At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccinia antibody levels |  | Day 5 post VIGIV-infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smallpox, vaccination, complications