WU 409: Immune Responses to Rabies Vaccine in the Presence and Absence of Neutralizing Antibodies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Comparison of antibody titers at D28 versus baseline
研究概览
简要总结
This study will evaluate the immune response to rabies vaccination persons 18 years and older. We will evaluate thirty healthy participants across three cohorts: 1) standard rabies pre-exposure prophylaxis regimen (two doses of Imovax® or RabAvert® seven days apart with no RIG); 2) rabies pre-exposure prophylaxis regimen + day 0 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 0); 3) rabies pre-exposure prophylaxis regimen + day 28 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 28).
详细描述
This study will evaluate the immune response to rabies vaccination persons 18 years and older. We will evaluate thirty healthy participants across three cohorts: 1) standard rabies pre-exposure prophylaxis regimen (two doses of Imovax® or RabAvert® seven days apart with no RIG); 2) rabies pre-exposure prophylaxis regimen + day 0 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 0); 3) rabies pre-exposure prophylaxis regimen + day 28 RIG (two doses of Imovax® or RabAvert® seven days apart, with RIG administered at day 28).
RANDOMIZATION PROCEDURES Participants will be randomized 1:1 to either:
Arm-1 Imovax or RabAvert- 2 doses 7 days apart or Arm-2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
Once 20 participants are enrolled to arms 1 and 2 10 more participants will be enrolled to:
Arm-3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants over 18 years of age.
- •Able to understand and give informed consent.
- •Willing to receive rabies vaccine
- •In stable health, as determined by medical history and targeted physical exam related to this history.
- •5. For those willing to give FNA, CBL and BMA samples, Willing to: give FNA specimens OR give CBL specimens OR give bone marrow aspirates OR give both FNA and BMA specimens OR give both FNA and CBL specimens OR give FNA, CBL and BMA specimens
排除标准
- •Receipt of prior rabies vaccination or risk for rabies exposure requiring standard vaccination
- •Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
- •Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- •Is acutely ill or febrile (temperature >38.0 C [100.4F] less than 72 hours prior to or at the day 1 visit. Participants who meet this criteria may be rescheduled.
- •Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
- •History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
- •Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.
- •Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
- •Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days after the last blood draw.
- •Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
- •Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core lymph node biopsy for participants willing to have those procedures done
- •Known IgA deficiency, as this is a known risk factor for anaphylactic reactions to Rabies immunoglobulin.
研究组 & 干预措施
Arm-1 Imovax or RabAvert- 2 doses 7 days apart
Imovax or RabAvert- 2 doses 7 days apart
干预措施: Imovax (Drug)
Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
干预措施: RabAvert (Drug)
Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
干预措施: HyperRAB (Drug)
Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
干预措施: HyperRAB (Drug)
Arm-1 Imovax or RabAvert- 2 doses 7 days apart
Imovax or RabAvert- 2 doses 7 days apart
干预措施: RabAvert (Drug)
Arm 2 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
Imovax or RabAvert- 2 doses 7 days apart with RIG at day 0
干预措施: Imovax (Drug)
Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
干预措施: RabAvert (Drug)
Arm 3 Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
Imovax or RabAvert- 2 doses 7 days apart with RIG at day 28
干预措施: Imovax (Drug)
结局指标
主要结局
Comparison of antibody titers at D28 versus baseline
时间窗: 28 days
Comparison of antibody titers at D28 versus baseline
Comparison of antibody titers at D365 versus baseline
时间窗: 365 days
Comparison of antibody titers at D365 versus baseline
次要结局
- Frequency serious adverse events(time of consent to day 365)
研究者
Rachel Presti
Professor in Department of Medicine, Division of Infectious Disease Washington University, St. Louis, MO
Washington University School of Medicine