An Open-label, Randomized Study Evaluating the Safety and Immunogenicity of the Purified Vero Cell Rabies Vaccine PVRV Administered Intradermally and Intramuscularly as Post-exposure Prophylaxis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response.
研究概览
简要总结
Rabies is fatal disease but preventable with rabies vaccines and immunoglobulins, conventionally involves intramuscular (IM) administration of the vaccine. However, switching the intradermal (ID) route offers potential advantages in dosing, time and cost without compromising efficacy and safety. Therefore, this study aims to compare the safety and immunogenicity of a short-term three-doses intradermal regimen (3D-ID) with a conventional five-doses intramuscular regimen (5D-IM) of the purified Vero cell rabies vaccine (PVRV), administered via both intramuscular (IM) and intradermal (ID) routes as post-exposure prophylaxis (PEP).
详细描述
Rabies vaccines can be used ID for PEP, according to a WHO Expert Committee recommendation. The administration of short-term PEP through ID (3-doses) offers a safe, immunogenic, dose-sparing, and cost-effective alternative to the conventional protocol (IM, 5-dose regimen) while reducing the volume by up to 60 to 80% and vaccination schedules by 3 weeks. This strategy has the potential to reduce the overall requirement and cost of such vaccines, along with minimizing the burden on healthcare professionals and facilities. Furthermore, this strategy is more likely to improve vaccination compliance compared to conventional protocol, and will certainly improve treatment outcomes.
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
- None
入排标准
- 年龄范围
- 2 Years 至 76 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 2 year or older
- •Both male and female
- •Dog-bite cases only
- •Informed consent form signed by the individual participant and/or their parents or guardian in case of minor age or major Trauma
排除标准
- •Subject is participating in any other clinical trial.
- •Pregnant and lactating women
- •Have a plan to donate blood while participating in the study
- •Received any other vaccine except rabies vaccines in last 6 months
结局指标
主要结局
To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response.
时间窗: 56 days
Patients were assigned into two groups each consisting of n=50 patients: Group-1 and Group-2. Group-1 were administered PVRV intradermally in a dose of 0.2ml on day 0, day 3, and day 7 as post exposure prophylaxis. While, patients in the group-2 received PVRV intramuscularly in a dose of 0.5ml on day 0, day 3, day 7, day 14 and day 28. Efficacy of PVRV in both groups were measured by the presence of rabies virus neutralizing antibodies (RVNA). Patients with an RVNA titer of ≥ 0.5 IU/mL were considered immunized.
次要结局
- To evaluate the safety of PVRV administered intradermally and intramuscularly based on the frequency of adverse drug events(42 days)
研究者
Mohammad Ismail
Dr. Mohammad Ismail Associate Professor of Clinical Pharmacy
University of Peshawar