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.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 561
- 试验地点
- 6
- 主要终点
- Primary: boostability
研究概览
简要总结
A multicentre, open label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens (2 x 1IM regimen, 2 x 2 ID regimen, 1 x 2 ID regimen) when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming.
详细描述
This multicentre clinical trial will include 561 participants, allocated evenly across 3 groups (187 per group). Participants are assigned to one of three groups according to their prior PrEP regimen, provided their last dose was given at least 5 years prior to enrollment.
• Group 1: 21IM regimen, (N = 187): received PrEP at least 5 years ago through 1 x 1,0 mL IM injection (Day 0 and Day 7), with a 7-day interval between visits (interval of 5 to 56 days is allowed).
• Group 2: 2²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections (Day 0 and Day 7) with a 7-day interval between visits (interval of 5 to 56 days is allowed).
• Group 3: 1²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections on Day 0
All subjects will receive 1 x 1,0 mL IM injection of purified chick-embryo cell-culture rabies vaccine as sPEP (booster) at least five years after primary vaccination (PrEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 to ≤ 60 years of age at time of inclusion
- •Willingness to provide written informed consent
- •Having received PrEP with a 21IM, 2²ID or 1²ID regimen at least 5 years before starting the study. For 21IM and 2²ID interval of 5 days to 56 days between the 2 visits is allowed.
排除标准
- •Known allergy to one of the components of the vaccine.
- •Subjects, who received immunomodulating therapy within the last 3 months (12 weeks).
- •Note: See Section 6.3 for detailed guidance on immunomodulating therapies.
- •Planned vaccination with any inactivated vaccine within 2 weeks before or after vaccination in the study or with any live attenuated vaccine within 1 month before or after each vaccination in the study.
- •Ongoing pregnancy or active child wish at the time of booster vaccination (D0).
- •Any other PrEP rabies vaccine schedule/vaccination than mentioned in the inclusion criteria.
- •Previous rabies (s)PEP
- •Inability or unwillingness to comply with study procedures, including protocol-defined visits, assessments, or interventions.
研究组 & 干预措施
Group 1: 2 x 1IM regimen, (N = 187):
Healthy volunteers that received Pre-Exposure Prohphylaxis (PrEP) (a rabies vaccination) at least 5 years ago through 1 x 1,0 mL IM injection (Day 0 and Day 7), with a 7-day interval between visits (interval of 5 to 56 days is allowed).
干预措施: Booster vaccination (Biological)
Group 2: 2²ID regimen (N = 187):
Received PrEP vaccination (Pre-Exposure prophylaxis usinga rabies vaccine) at least 5 years ago through 2 x 0,1 mL ID injections (Day 0 and Day 7) with a 7-day interval between visits (interval of 5 to 56 days is allowed).
干预措施: Booster vaccination (Biological)
Group 3: 1²ID regimen (N = 187)
received PrEP (Pre-Exposure prophylaxis using a rabies vaccine) at least 5 years ago through 2 x 0,1 mL ID injections on Day 0
干预措施: Booster vaccination (Biological)
结局指标
主要结局
Primary: boostability
时间窗: 13 months - from First Patient In (FPI) to Last Patient Out (LPO)
To investigate whether the boostability of a (A) two-visit IM, (B) two-visit ID and (C) one-visit ID Pre-exposure Prophylaxis (PrEP) regimen is non-inferior to a theoretical 99% boostability when a single-dose IM simulated Post Exposure Prophylaxis (sPEP) is administered at least 5 years after the PrEP regimen. Primary Endpoint: Proportion of participants that have an adequate immune response (Rapid Fluorescent Focus Inhibition Test (RFFIT) level, WHO standard) on Day 7 after the booster.
次要结局
- RFFIT levels ≥ 0.5 IU/mL Day 14(14 days following booster vaccination)
- FFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0).(Day 0 - on day of booster vaccination)
- RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster(Day 7 - following booster vaccination)
- RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster.(Day 14 after the booster vaccination)
- RFFIT levels ≥ 10 IU/mL on Day 7 after the booster.(Day 14 following the booster vaccination)
- RFFIT levels ≥ 10 IU/mL on Day 14 after the booster.(Day 14 following the booster vaccination.)
- Safety objectives(1. & 2. Day 7 following the booster vaccination. 3. 13 months - entire study duration FPI to LPO)