Comparison of efficacy between intramuscular and intradermal injection of Hepatitis B vaccine in Buali Sina dialysis centre, Qazvin.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
Background: Low immunogenicity of hepatitis B vaccine is an important problem in patients with chronic renal failure (CRF). A possible solution is intradermal versus conventional intramuscular delivery of vaccine in this population. The goal of this study was to compare the efficacy of these routes of vaccination in Bu-alicina Dialysis Center, Qazvin, Iran. Materials and Methods: This randomized clinical trial was done on 29 CRF non-responders randomly allocated to two groups. Fifteen patients received 40 µg of euvax B vaccine intradermally and 14 patients received 160 µg of this vaccine intramuscularly. Anti-HBs antibody titre was measured after 1, 6, and 12 months. Seroprotection was defined as anti-HBs antibody titre above 10 lU/L. Data were analyzed using SPSS software version 16. Results: Difference of seroprotection rate between two groups was not statistically significant after1and 6 months; however, after 12 months, seroprotection rate was 93.3% in the interadermal group versus 50% in the intramuscular group (p
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 14 years 至 no limit(—)
- 性别
- All
入选标准
- •CRF patients who are under dialysis (hemodyalisis or peritoneal dialysis) in Bualisina dialysis centre, HBsAg lower than 10 U/ml and at least a previous course of hepatitis B vaccination.
- •Exclusion criteria: Presence of malignancy, severe malnutrition, positive HBsAg, kidney transplantation, immunocompromising disease such as AIDS.
排除标准
- 未提供
