2023-507065-26-00已完成3 期
A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal and intramuscular rabies vaccination < RABISKIMM >
Institute Of Tropical Medicine2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2024年1月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- The percentage and absolute number of skin-resident and RABV-specific T cells within the CD3+ lymphocyte parent population after booster vaccination at D120+14, measured by flow cytometry.
研究概览
简要总结
To compare the number and proportion of skin-resident memory T cells against RABV (RABV-TRM) after booster dose by vaccination route.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
The percentage and absolute number of skin-resident and RABV-specific T cells within the CD3+ lymphocyte parent population after booster vaccination at D120+14, measured by flow cytometry.
The percentage and absolute number of skin-resident and RABV-specific T cells within the CD3+ lymphocyte parent population after booster vaccination at D120+14, measured by flow cytometry.
次要结局
- Percentage and absolute number of circulating and RABV-specific TCM and TEM cells within the CD3+ lymphocyte parent population at D120+14
- Percentage and absolute number of increase in RABV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population from D28 to D120+14
- Percentage and absolute number of RABV-specific TRM, TCM and TEM CD4+ and CD8+ T cells within the CD3+ lymphocyte parent population at D28 and D120+14, and their percentage and absolute number of increase from D28 to D120+14
- The geometric mean titres (GMTs) of neutralizing RRFIT test at D210+14
- The nAbs GMT titres, IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU at D0, D7, D28, D120, D120+14, D120+90, measured by RRFIT and elispot/fluorospot respectively.
- At all timepoints, the geometric mean titres (GMTs) of neutralizing RRFIT test and IFNy+ spot forming units (SFU) and IFNy/TNF-a/IL-2+ SFU. In addition at D28 and D120+14, the percentage and absolute number of RABV-specific TRM, TCM and TEM cells within the CD3+ lymphocyte parent population.
研究者
Wim Adriaensen
Scientific
Institute Of Tropical Medicine
研究点 (2)
Loading locations...
相似试验
招募中
4 期
Vaccination against respiratory syncytial virus in patients with inflammatory rheumatic diseases. The impact of anti-rheumatic treatments on the RSV immune response.2024-518191-31-00Region Skane180
招募中
4 期
A clinical phase IV trial to examine cellular and humoral immunity against measles and chickenpox in children and adolescents 0-18 years in childhood cancer.2024-511182-10-01Vaestra Goetalandsregionen160
招募中
3 期
Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers2023-505762-29-00Sanofi Pasteur Inc.340
招募中
4 期
Evaluating, clinical and immunological effects of rituximab with cyclophosphamide compared to rituximab alone in AAV patients2023-507868-39-00Academisch Ziekenhuis Leiden100
招募中
3 期
A Study to Evaluate Tobevibart+Elebsiran in Participants with Chronic HDV Infection Not Virologically Suppressed with Bulevirtide2024-519282-22-00Vir Biotechnology Inc.132