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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT01374984
First received: June 14, 2011
Last updated: April 22, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Complication of Smallpox Vaccination
Biological: VIGIV
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Primary Outcome Measures:
  • Resolution of vaccinia infection complications [ Time Frame: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccinia antibody levels [ Time Frame: Day 5 post VIGIV-infusion ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 100
Study Start Date: August 2007
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Vaccinia Immune Globulin Intravenous (Human)

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374984

Sponsors and Collaborators
Cangene Corporation
Investigators
Study Chair: Jason S Richardson, PhD Cangene Corporation (doing business as Emergent BioSolutions)
  More Information

Additional Information:
No publications provided

Responsible Party: Cangene Corporation
ClinicalTrials.gov Identifier: NCT01374984     History of Changes
Other Study ID Numbers: VA-005
Study First Received: June 14, 2011
Last Updated: April 22, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cangene Corporation:
smallpox
vaccination
complications

Additional relevant MeSH terms:
Kernicterus
Smallpox
Blood Group Incompatibility
Brain Diseases
Brain Diseases, Metabolic
Central Nervous System Diseases
DNA Virus Infections
Erythroblastosis, Fetal
Hematologic Diseases
Hyperbilirubinemia
Immune System Diseases
Infant, Newborn, Diseases
Metabolic Diseases
Nervous System Diseases
Pathologic Processes
Poxviridae Infections
Virus Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 30, 2015