NCT03472014已完成4 期
A Special Access Program for the Prophylactic Vaccination With IMVAMUNE® for Personnel Working Directly With or in the Vicinity of Replicating Vaccinia Virus
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- ELISA Seropositivity Rate
研究概览
简要总结
Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. Subjects may be vaccinia-naïve or vaccinia-experienced.
- •Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to vaccination.
- •WOCBP must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. A woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to barrier contraceptives which include Food and Drug Administration (FDA)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.)
- •Read, signed and dated Informed Consent Form.
排除标准
- •Pregnant or breast-feeding women.
- •Uncontrolled serious infection i.e., not responding to antimicrobial therapy.
- •History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- •Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects.
- •History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure.
- •History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
- •History of allergies or reactions to eggs, egg products, or gentamycin.
- •Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after IMVAMUNE®vaccination.
- •Chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination.
- •Use of any investigational or non-registered drug or vaccine other than IMVAMUNE® within 30 days preceding the first vaccine dose.
研究组 & 干预措施
IMVAMUNE®
Experimental
Two subcutaneous vaccinations with 0.5 mL IMVAMUNE® vaccine administered at a 4 week intervals
干预措施: IMVAMUNE® (Biological)
结局指标
主要结局
ELISA Seropositivity Rate
时间窗: up to Week 7
Seropositivity rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seropositivity is defined as antibody titers ≥ detection limit (50). Percentages based on number of subjects with data available.
次要结局
- Serious Adverse Events(up to 32 weeks)
- Related Grade >=3 Adverse Events(within 29 days after any vaccination)
- ELISA GMT(up to Week 7)
- Non-serious AEs(within 29 days after any vaccination)
- ELISA Seroconversion Rate(Week 7)
研究者
研究点 (1)
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