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.)
Information provided by (Responsible Party):
First received: June 14, 2011
Last updated: July 23, 2012
Last verified: July 2012
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.
Complication of Smallpox Vaccination
||Treatment of Smallpox Vaccination Complications With CNJ-016
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 ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- vaccinia antibody levels [ Time Frame: day 5 post infusion ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||August 2017 (Final data collection date for primary outcome measure)
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.
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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
- 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
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
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 14, 2011
||July 23, 2012
||United States: Food and Drug Administration
Keywords provided by Cangene Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 25, 2015
Blood Group Incompatibility
Brain Diseases, Metabolic
Central Nervous System Diseases
DNA Virus Infections
Immune System Diseases
Infant, Newborn, Diseases
Nervous System Diseases
Rho(D) Immune Globulin
Physiological Effects of Drugs