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

Complication of Smallpox Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01374984
• Other study ID #: VA-005
• Status: Enrolling by invitation
• Start date: August 2007
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Emergent BioSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Smallpox Vaccination
• Smallpox
• Vaccinia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emergent BioSolutions	Centers for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of vaccinia infection complications		At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)
Secondary	Vaccinia antibody levels		Day 5 post VIGIV-infusion

External Links

•   VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] United States Prescribing Information, 1/2010.