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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2027-08-31

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.

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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.

Conditions

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Complication of Smallpox Vaccination

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects treated with VIGIV.

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).

VIGIV

Intervention Type BIOLOGICAL

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.

Interventions

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VIGIV

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Vaccinia Immune Globulin Intravenous (Human)

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.