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

Emergent BioSolutions

Status: Invitation-only

Conditions: Complication of Smallpox Vaccination

Treatments: Biological: VIGIV

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01374984

VA-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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.

Exclusion criteria

None.

Trial design

100 participants in 1 patient group

Subjects treated with VIGIV.

Description:

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).

Treatment:

Biological: VIGIV