Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) Using the Zagreb Regimen as Simulated Rabies Post-exposure Prophylaxis in Healthy Adults in Thailand
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification
研究概览
简要总结
Primary Objective:
To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.
Secondary Objective:
Immunogenicity To describe the immune response induced by VRVg-2 and Verorab vaccines at D90 when co-administered with HRIG at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.
Safety To describe the safety profile of VRVg-2 and Verorab vaccines when co administered with HRIG at D0, after each vaccination.
详细描述
The duration of each subject's participation in the study will be approximately 7 months (21 day-vaccination period followed by 6 months safety follow-up period).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1: VRVg-2 + HRIG
VRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21
+ HRIG at D0
干预措施: Purified vero rabies vaccine - serum free (Biological)
Group 1: VRVg-2 + HRIG
VRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21
+ HRIG at D0
干预措施: Human rabies immunoglobulins (Biological)
Group 2: Verorab + HRIG
Verorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21
+ HRIG at D0
干预措施: Purified inactivated rabies vaccine (Biological)
Group 2: Verorab + HRIG
Verorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21
+ HRIG at D0
干预措施: Human rabies immunoglobulins (Biological)
结局指标
主要结局
Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification
时间窗: Day 35 (post-vaccination)
RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)
时间窗: Day 35 (post-vaccination)
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 35 - RVNA ratios Day35/Day0 will be calculated
Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
时间窗: Day 14 (post-vaccination)
RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
Percentage of participants achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL
时间窗: Day 35 (post-vaccination)
RVNA titers will be measured by RFFIT
次要结局
- Number of participants reporting immediate adverse events (AEs)(Within 30 minutes post-vaccination)
- Percentage of participants reporting solicited injection site and systemic reactions(Within 7 days post-vaccination)
- Number of participants reporting unsolicited injection site AEs(Within 28 days post-vaccination)
- Number of participants reporting unsolicited systemic AEs(Between each vaccination and up to 28 days after the last vaccination)
- Number of participants reporting serious adverse events (SAEs)(Up to 6 months after last vaccination)
- Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL(Day 90 (post-vaccination))
- Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification(Day 90 (post-vaccination))
- Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)(Day 90 (post-vaccination))