VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Inf… (NCT01374984) | Clinical Trial Compass
By InvitationNot Applicable
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
100 participantsStarted 2007-08
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is 'enrolling by invitation only,' can you explain whether I or my family member would even be considered eligible, and what circumstances would lead to someone being invited to participate?
2This study is tracking whether VIGIV (Vaccinia Immune Globulin Intravenous) resolves complications from smallpox vaccination — can you walk me through what specific complications this treatment is meant to address, and how serious those complications typically are?
3Since this trial is listed as Phase NA, which often means it's more of an observational or emergency-use data collection study rather than a traditional drug trial, does that change how we should think about the evidence behind VIGIV's safety and effectiveness?
4Are there standard-of-care alternatives to VIGIV for treating smallpox vaccination complications that we should consider alongside or instead of this trial, and how does the evidence for those compare?
5Given that this trial involves a complication from a smallpox vaccination, can you help me understand the context — for example, was this vaccination recent, required, or given under a specific program — and how that affects what treatment options are realistically available to us?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resolution of vaccinia infection complications
Timeframe: At hospital discharge (if not fully resolved at discharge then 1 month or 6 months as applicable)