Vaccinia Immune Globulin Intravenous (VIGIV) in Treatment of Complications of Smallpox Vaccination

This study has suspended participant recruitment.
(Enrolment is temporarily on hold due to transfer of ethical oversight from BioMed IRB to a different central IRB.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT01374984
First received: June 14, 2011
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

This is a post-marketing study to verify the clinical benefits of CNJ-016 in the resolution of complications resulting from smallpox vaccination in eligible patients treated with CNJ-016.


Condition Intervention Phase
Complication of Smallpox Vaccination
Biological: CNJ-016
Phase 4

Study Type: Observational
Official Title: Treatment of Smallpox Vaccination Complications With CNJ-016

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 infusion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum


Estimated Enrollment: 100
Study Start Date: August 2007
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: CNJ-016
    CNJ-016 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.
Detailed Description:

This is an open-label Phase 4 study designed to collect additional data to assess the safety and efficacy of CNJ-016 in the first 100 consented patients treated with CNJ-016.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals who receive smallpox vaccination (or their contact(s)) who develop any of the known complications of vaccination with vaccinia virus that are treatable by vaccinia immune globulin (VIGIV). Any U.S. facility treating an eligible patient is a potential study site.

Criteria

Inclusion Criteria:

Clinical diagnosis of the following complications of smallpox vaccination:

  • 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
  • Aberrant infections induced by vaccinia virus that include implementation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard

Exclusion Criteria:

  • History of anaphylaxis or a prior severe reaction associated with IV or IM administration of human immunoglobulin preparations
  • Selective immunoglobulin A (IgA) deficiency
  • Presence of isolated vaccinia keratitis
  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.

No Contacts or Locations Provided
  More 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: July 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cangene Corporation:
smallpox
vaccination
complications

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014