Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 主要终点
- Resolution of vaccinia infection complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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).
干预措施: VIGIV (Biological)
结局指标
主要结局
Resolution of vaccinia infection complications
时间窗: 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.
Resolution of vaccinia infection complications
时间窗: 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.
次要结局
- Vaccinia antibody levels(Day 5 post VIGIV-infusion)
- Vaccinia antibody levels(Day 5 post VIGIV-infusion)