CTIS2023-507065-26-00进行中（未招募）1 期
A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal and intramuscular rabies vaccination < RABISKIMM >
Institute Of Tropical Medicine0 个研究点目标入组 165 人开始时间: 2023年10月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •MAIN + PILOT + HEALTHY CONTROL GROUP: >/=18 to =50 years of age, PILOT: should have had a completed or partly completed schedule of rabies vaccination more than one month prior to recruitment, PILOT: BMI =30 kg/m2, PILOT: Able and willing to provide written informed consent, PILOT: No acute illness at time of recruitment, MAIN + PILOT: Willing to use contraception during the course of the trial (for women of childbearing potential), PILOT: Not pregnant or planning to become pregnant during the course of the trial, HEALTHY CONTROL GROUP: Able and willing to provide written informed consent, HEALTHY CONTROL GROUP: Agreement to share and discuss participant’s medical history and medical records when relevant, HEALTHY CONTROL GROUP: No acute illness at time of recruitment, MAIN: BMI =30 kg/m2, MAIN: Agreement to refrain from blood donation and other vaccinations 30 days following each vaccination, MAIN: Agreement to share and discuss participant’s medical history and medical records when relevant, MAIN: Able and willing to provide written informed consent
排除标准
- •MAIN + PILOT: Subjects who received a rabies vaccination prior to recruitment (including a single dose), MAIN + PILOT: Pregnancy or planning to become pregnant during the course of the trial, MAIN + PILOT + HEALTHY CONTROL GROUP: Subjects who received PEP (or immunoglobulines), MAIN + PILOT: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment, MAIN + PILOT: Active participation in another interventional clinical study with active substance intake during the trial or 1 month prior to recruitment, MAIN + PILOT: Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months prior to recruitment, except topical or short-term oral steroids., MAIN + PILOT: Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed), MAIN + PILOT: History of anaphylaxis, allergic disease or reactions to any component of the study vaccines, HEALTHY CONTROL GROUP: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment., MAIN + PILOT : Tendency to keloid (scar) formation in response to skin damage, MAIN + PILOT + HEALTHY CONTROL GROUP: Skin diseases at the biopsy and vaccination site, MAIN + PILOT: History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture, MAIN + PILOT: Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data, HEALTHY CONTROL GROUP: Subjects who received a rabies vaccination prior to recruitment (including a single dose), HEALTHY CONTROL GROUP: Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment, HEALTHY CONTROL GROUP: Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids., HEALTHY CONTROL GROUP: Any other significant disease, disorder, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data, HEALTHY CONTROL GROUP: Suspected or known alcohol or drug dependency, MAIN + PILOT: Suspected or known alcohol or drug dependency
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