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

N/AEnrolling By InvitationNCT01374984

Emergent BioSolutions100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Complication of Smallpox Vaccination

Interventions

VIGIVBIOLOGICAL

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Resolution of vaccinia infection complications

Change in number, size, type, and percentage of body affected by lesions following treatment.

Time frame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)

Secondary Outcomes

Vaccinia antibody levels

Measurement of serum concentration of anti-vaccinia antibodies.

Time frame: Day 5 post VIGIV-infusion

Data from ClinicalTrials.gov

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