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

March 7, 2024 updated by: Emergent BioSolutions

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resolution of vaccinia infection complications
Time Frame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)
At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)

Secondary Outcome Measures

Outcome Measure
Time Frame
Vaccinia antibody levels
Time Frame: Day 5 post VIGIV-infusion
Day 5 post VIGIV-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergent BioSolutions

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Study Chair: David Cassie, MSc, Emergent BioSolutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2007

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimated)

June 17, 2011

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VA-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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