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

• Conditions: Complication of Smallpox Vaccination
• Interventions: Biological: VIGIV

• Registration Number: NCT01374984
• Lead Sponsor: Emergent BioSolutions

Brief Summary

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

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects treated with VIGIV.	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Vaccinia antibody levels	Day 5 post VIGIV-infusion