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

Sponsor

Emergent BioSolutions (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT01374984

Collaborator

Centers for Disease Control and Prevention (U.S. Fed)

100

Enrollment

216

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complication of Smallpox Vaccination	Biological: 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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2007

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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).	Biological: 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. Other Names: Vaccinia Immune Globulin Intravenous (Human)

Arm

Intervention/Treatment

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).

Biological: 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.

Other Names:

Vaccinia Immune Globulin Intravenous (Human)

Outcome Measures

Primary Outcome Measures

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

Vaccinia antibody levels [Day 5 post VIGIV-infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.