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Enrolling by Invitation

NCT Number: NCT01374984

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

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.

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Key information

Conditions

Complication of Smallpox Vaccination DNA Virus Infections Infections Poxviridae Infections Smallpox Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Vaccinia Immune Globulin Intravenous (Human)

Primary outcomes

  1. Resolution of vaccinia infection complications

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

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

Secondary outcomes

  1. Vaccinia antibody levels

    Time frame: Day 5 post VIGIV-infusion

    Measurement of serum concentration of anti-vaccinia antibodies.

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2027
Study completion
2028
First posted
Jun 17, 2011
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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