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

NCT01374984 | Enrolling By Invitation FDA Drug

• 1 other identifier: VA-005
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complication of Smallpox Vaccination

Keywords

smallpox; vaccination; complications

Outcome Measures

Primary Outcomes (1)

• Resolution of vaccinia infection complications

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

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

Secondary Outcomes (1)

• Vaccinia antibody levels

  Day 5 post VIGIV-infusion

Study Arms (1)

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

Interventions

VIGIV BIOLOGICAL

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.

Also known as: Vaccinia Immune Globulin Intravenous (Human)

Subjects treated with VIGIV.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals who are administered VIGIV distributed from the US Strategic National Stockpile for the treatment of complications due to vaccinia vaccination or vaccinia infections.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Centers for Disease Control and Prevention: collaborator

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

A plasma sample for the determination of anti-vaccinia antibody level collected 5 days after VIGIV administration and 5 days after VIGIV re-dosing as well (if applicable). Samples collected Day 5 ±3 days will still provide valuable information for assessing anti-vaccinia antibody levels in these subjects post-VIGIV administration. While plasma samples are preferred, serum samples will also be accepted if available. Failure to obtain a Day 5 sample does not preclude retrospective enrollment into the VA-005 study to provide observational data only.

MeSH Terms

Conditions

Smallpox

Interventions

human intravenous vaccinia immune globulin

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• David Cassie, MSc

  Emergent BioSolutions

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 17, 2011
• Study Start: August 1, 2007
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10