Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change from baseline in serum HBsAb level
研究概览
简要总结
The purpose of this study is to determine whether short-term Atorvastatin can increase the immunity response to hepatitis B vaccination in vaccine Nonresponders.
详细描述
20 person of vaccinated individuals who have HBsAb<10 after 3 dose hepatitis B vaccination who called Nonresponders will be randomly allocated in 2 groups. one group receive short-term Atorvastatin and other group receive placebo.both group will be vaccinated with hepatitis B vaccine and then immunity response will be measured.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous 3 dose hepatitis B vaccination
- •Negative HBc Ab
- •Negative HBs Ag
- •HBs Ab less than 10 in ELIZA
排除标准
- •positive serologic evidence of Hepatitis B infection
- •Chronic use of Atorvastatin
- •Immunosuppressive Disease
研究组 & 干预措施
Atorvastatin
will receive one 40 mg Atorvastatin tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle
干预措施: Atorvastatin (Drug)
Placebo
will receive one Placebo tablet orally per day for 10 days and in 5th day 1 dose of recombinant yeast-derived Hepatitis B vaccine intramuscular in left Deltoid muscle
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in serum HBsAb level
时间窗: 1 month after vaccination
HBsAb level in serum measurement with quantitative ELIZA method
次要结局
- IL-4 level in WBC culture(1 month after vaccination)
- IL 17 level in WBC culture(1 month after vaccination)
- TGF-beta level in WBC culture(1 month after vaccination)
- IFN-gamma level in WBC culture(1 month after vaccination)
研究者
Nematollah Jonaidi Jafari
Head of Health Research Center
Baqiyatallah Medical Sciences University