Safety of Rabivax-S in Individuals Receiving Pre-exposure Prophylaxis (PrEP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Number of participants with at least one solicited adverse event (AE) within 4 days after any dose
研究概览
简要总结
People who are at frequent or continuous risk of exposure to rabies virus should be vaccinated against the disease (pre-exposure prophylaxis). This includes people who work with rabies virus in research or diagnostic laboratories or vaccine production facilities, veterinarians, staff, animal-control and wildlife workers in areas where rabies is endemic. Veterinary students in clinical placements and externships are included in this category. Currently, DVM students at Ross University School of Veterinary Medicine (RUSVM) are vaccinated against rabies in their 7th semester (final pre-clinical semester). Vaccinations are done by RUSVM Health Services using Rabivax-S, produced by the Serum Institute of India (study co-sponsors). Previously-unvaccinated students receive three injections of vaccine, on day 0, 7 and 21-28. The aim of the study is to generate additional data on safety and tolerability of Rabivax-S administered as pre-exposure prophylaxis to this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A DVM student registered at RUSVM will be eligible for inclusion in the study if the student is:
- •in the 7th semester of the DVM program, or
- •is in the 5th or 6th semester of the DVM program and is planning to undertake a veterinary externship in the following semester break that would require pre-exposure prophylaxis to rabies.
排除标准
- •A DVM student who meets the inclusion criteria will be excluded from the study if the student:
- •has previously received a dose of rabies vaccine, or
- •has any condition for which rabies vaccination is contra-indicated, or
- •does not provide informed consent for participation.
结局指标
主要结局
Number of participants with at least one solicited adverse event (AE) within 4 days after any dose
时间窗: Through 4 days after each dose
Based on the package insert for Rabivax-S, the following adverse events will be solicited: * Local reactions (limited to the site of the injection): pain, erythema, oedema, pruritus and induration. * Systemic reactions: fever, shivering, malaise, asthenia, faintness, dizziness, headache, myalgia, arthralgia, nausea and abdominal pain. * Hypersensitivity or allergic reactions: anaphylaxis, urticaria, rash and erythema multiforme.
次要结局
- Number of serious adverse events during 28 days after the first dose(Through 28 days after the first dose given (day 0))
- Number of participants with at least one solicited adverse event (AE) within 4 days after first dose(Through 4 days after first dose (days 0-3))
- Number of participants with at least one solicited adverse event (AE) within 4 days after third dose(Through 4 days after second dose (days 21-24 or days 28-31))
- Number of unsolicited adverse events during 28 days after the first dose(Through 28 days after the first dose given (day 0))
- Number of participants with at least one solicited adverse event (AE) within 4 days after second dose(Through 4 days after second dose (days 7-10))
研究者
Darryn Knobel
Professor of Epidemiology and Population Health
Ross University School of Veterinary Medicine