An open label, non-inferiority randomized controlled trial of intradermal versus intramuscular administration of Hepatitis B vaccine in failed response to previous standard intramuscular schedule of Hepatitis B vaccination in patients of end stage renal disease on haemodialysis.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- To compare the responses i.e. anti-HBsAb titres greater than 10 mIU/ml between IM and ID vaccination arms in patients with a failed response to primary Hep B vaccination.
研究概览
简要总结
The study aims to investigate the effectiveness of intradermal versus intramuscular adminstration of Hepatitis B vaccine in patients with chronic kidney disease (CKD). The study is an open label, non-inferiority randomized controlled trial, focusing on patients who have already completed their primary vaccination schedule of 4 doses and have not developed any protective titres or those with very low (<10 mIU/ml). The study is part of CDC’s guidelines for CKD patients, which recommend a specific vaccine and schedule. The vaccine is generally given intramuscularly in the deltoid region of arm, with standard dose scheduled at 0, 1, 2 and 6 month intervals. While the intradermal route currently gaining attention will be studied simultaneously in the study population and the response to both vaccination methods along with factors, influencing the response will be studied.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic kidney disease patients on MHD for a minimum of 3 months with age 18 years or above.
- •Have undergone a complete previous primary series of IM double dose vaccination i.e. 40 microgram of recombinant hepatitis B vaccine at 0, 1, 2 and 6 months after initiation of hemodialysis.
- •Previously vaccinated patients who currently have Anti-HbsAb titres less than 10mIU/ml.
- •Patients on regular follow up and complete records.
- •Patients agreeing to participate in this study by signing informed consent forms.
排除标准
- •CKD patients not on maintenance haemodialysis or on peritoneal dialysis.
- •Patients eligible for renal transplant within next 6 months.
- •Patients found to be HbsAg positive Vaccinated with any other vaccine within 2 weeks.
- •Patients who have been administered a booster dose of Hep B vaccine irrespective of timeline.
- •Patients not willing to participate in the study.
- •Pregnant or breastfeeding females.
结局指标
主要结局
To compare the responses i.e. anti-HBsAb titres greater than 10 mIU/ml between IM and ID vaccination arms in patients with a failed response to primary Hep B vaccination.
时间窗: 12 months
To compare the development of protective responses i.e. anti-HBsAb titres greater than 100 mIU/ml between IM and ID vaccination arms in patients with a failed response to primary Hep B vaccination.
时间窗: 12 months
次要结局
- To assess the change in titres at predefined time points prior to completion of vaccination schedule i.e at Week 4 for ID and Month 3 for IM and at Week 12 for ID and Month 7 for IM.(To determine factors affecting response to vaccination.)
研究者
Dr Tukaram Jamale
Seth GSMC & KEM Hospital