NCT03051386Unknown2 期
Phase 2 Open-Label Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis (VEE) Vaccine, Live Attenuated, Dried, TC-83, NDBR 102, Lot 4, Run 3, as Primary Vaccination in Healthy Adult Subjects at Risk of Exposure to VEE Virus
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年5月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Safety: Percentage of subjects with symptoms following VEE vaccination
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of VEE vaccine, Live, Attenuated, dried TC-83, NDBR 102, Lot 4, Run 3, and collect data on the incidence of occupational VEE virus infection in vaccinated personnel.
详细描述
This protocol is replacing NCT00582504.
The study population will consist of USAMRIID and qualified extramural participants who are at risk of exposure to VEE virus. This study will be performed at the USAMRIID SIP Clinic. This open-label study represents a continuation of previous research conducted at USAMRIID. Subjects will be vaccinated with 0.5 mL of VEE vaccine, Live, Attenuated TC-83, NDBR 102, Lot 4, Run 3 subcutaneously in the upper outer aspect of the triceps region. Subjects will contacted the following day and weekly for 4 weeks to assess for adverse events.
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
- •Be 18-65 years old at time of consent.
- •Have VEE virus PRNT80 < 1:
- •If female of childbearing potential, must agree to have a serum pregnancy test on the same day before vaccine administration. (Exception: documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females must agree not to become pregnant for 3 months after receipt of the vaccination.
- •Be considered at risk for exposure to VEE virus and who have submitted a Request for IND Vaccines for the VEE vaccine.
- •Sign and date the approved informed consent document and HIPAA Authorization.
- •Have in their charts:
- •medical history (including concomitant medications) within 60 days of planned first administration of vaccine
- •physical examination and laboratory tests within 1 year
- •previous chest radiograph results and electrocardiogram
- •Be medically cleared for participation by an investigator. Examinations or tests may be repeated at the discretion of the PI.
- •Be willing to return for all follow-up visits.
- •Agree to report any AEs that may or may not be associated with administration of the vaccine for at least 28 days after administration and agree to report all SAEs (for example, resulting in hospitalization) for the duration of the subject's participation in the study.
- •Agree to defer blood donation for 1 year after receipt of the vaccine.
排除标准
- •Have received VEE vaccine.
- •Have family history (first degree relative) of diabetes mellitus (any type), a personal or family history of gestational diabetes, a confirmed elevated fasting serum glucose test (> 125 mg/dL), or a hemoglobin A1c > 5.6%. (At the principal investigator's discretion, a subject may participate if the family history of diabetes is only of late onset in an elderly parent.)
- •Have clinically significant abnormal laboratory results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the PI).
- •Have a personal history of an immunodeficiency or received treatment with an immunosuppressive medication, such as systemically administered glucocorticoids (eg prednisone) within 1 month before planned administration of the vaccine or with other immunosuppressive therapies within 6 months of planned administration of the vaccine. Other immunosuppressive therapies include all cancer chemotherapeutic agents, drugs to prevent transplant rejection, interferons, monoclonal antibodies, protein kinase inhibitors, methotrexate, TNF (tumor necrosis factor) inhibitors, and any other drug determined to be immunosuppressive by the PI. Current administration of topical, inhalational, or intranasal glucocorticoids is not excluded.
- •Have confirmed HIV infection (antibody positivity).
- •Have a positive pregnancy test or a breastfeeding female.
- •Have any known allergies to components of the vaccine:
- •Neomycin sulfate
- •Guinea pig heart cells
- •Streptomycin
- •Human serum albumin
- •History of serious allergic reaction to guinea pigs or guinea pig products. (Subjects who have known allergies to guinea pigs will be evaluated. The vast majority of individuals who are allergic to guinea pigs are allergic to the dander from the animals. An individual with a past serious allergic reaction to guinea pigs will be excluded.)
- •Have administration of another vaccine or investigational product within 28 days of VEE vaccination.
- •Have any unresolved AE resulting from a previous immunization.
- •Have a medical condition that, in the judgment of the PI, would impact subject safety.
结局指标
主要结局
Safety: Percentage of subjects with symptoms following VEE vaccination
时间窗: 15 months
Collect and assess safety data for VEE vaccine
Safety: Occurrence of Serious Adverse Events and Adverse Events (SAEs and AEs)
时间窗: 15 months
Collect and assess safety data for VEE vaccine
Safety: Percentage of subjects with each AE, system organ class of AE, severity, and association with vaccination
时间窗: 15 months
Collect and assess safety data for VEE vaccine
次要结局
- Immunogenicity: Geometric Mean PRNT80 Titers of subjects(15 months)
- Immunogenicity: Percentage of subjects who develop titers of >1:20(15 months)
研究者
研究点 (2)
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