Complication of Smallpox Vaccination
Conditions
Keywords
smallpox, vaccination, complications
Brief summary
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.
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.
Interventions
BIOLOGICALVIGIV
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.
Sponsors
Emergent BioSolutions
Centers for Disease Control and Prevention
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of vaccinia infection complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Vaccinia antibody levels | Day 5 post VIGIV-infusion | Measurement of serum concentration of anti-vaccinia antibodies. |
Contacts
STUDY_CHAIRDavid Cassie, MSc
Emergent BioSolutions
Outcome results
None listed