2025-524765-24-00招募中3 期
A multicentre, open-label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming. "BAZOOKA_221"
Institute Of Tropical Medicine12 个研究点 分布在 1 个国家目标入组 561 人开始时间: 2026年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 561
- 试验地点
- 12
- 主要终点
- Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) levels ≥ 0.5 IU/mL, WHO standard) on Day 7 after the booster.
研究概览
简要总结
To investigate whether the boostability of a (A) two-visit Intra-muscular, (B) two-visit Intra-dermal and (C) one-visit Intradermal vaccination regimen is non-inferior to a theoretical 99% boostability when a single-dose Intramuscular vaccination is administered at least 5 years after the PrEP regimen.
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Open-label Trial In Healthy Volunteers
- 盲法
- None
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
- •Age ≥ 18 and ≤ 60 years at the time of inclusion.
- •Willing and able to provide written informed consent.
- •Having received rabies Rabies vaccination through a 2x1 IM, 2²ID, or 1²ID regimen at least 5 years prior to study start.
排除标准
- •Subjects with a known allergy to one of the components of the vaccines
- •Currently receiving or having received immunomodulating drugs within the past 3 months (12 weeks).
- •Planned vaccination with any inactivated vaccine within 2 weeks before or after the vaccinations in the study or with any live attenuated vaccine within 1 month before or after the vaccinations in the study.
- •Ongoing pregnancy or active child wish (for female subjects) at the time of booster vaccination (D0).
- •Any other PrEP rabies vaccination schedules than those mentioned in the inclusion criteria.
- •Previous rabies booster vaccinations
- •Inability or unwillingness to comply with study procedures,
研究组 & 干预措施
Rabipur Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in Fertigspritze Tollwutvirus (inaktiviert, Stamm Flury LEP)
Test
干预措施: Rabipur Pulver und Lösungsmittel zur Herstellung einer Injektionslösung in Fertigspritze Tollwutvirus (inaktiviert, Stamm Flury LEP) (Drug)
结局指标
主要结局
Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) levels ≥ 0.5 IU/mL, WHO standard) on Day 7 after the booster.
Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) levels ≥ 0.5 IU/mL, WHO standard) on Day 7 after the booster.
次要结局
- Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 14 after the booster
- geometric mean titers (GMTs) at all visits for all arms and the ratio with baseline GMTs per arm
- Proportion of participants with swelling, pain, redness, headache, fever, or fatigue per arm.
- Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster.
- Proportion of participants with RFFIT levels ≥ 10 IU/mL on Day 7 after the booster
- Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on Day 14 after the booster.
- Proportion of participants with RFFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0).
- Proportion of participants with RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster
- Proportion of participants with unsolicited (i.e., other) Adverse events per arm. Proportion of participants with unsolicited local reactions per arm.
- Proportion of participants with SAEs per arm throughout the study period after sPEP vaccination session. (EOT)
研究者
Patrick Soentjens
Scientific
Institute Of Tropical Medicine
研究点 (12)
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