Hepatitis B Vaccination (HBV) in HIV Infected Children
Immunogenicity and Safety of Intradermal Compare to Intramuscular Hepatitis B Vaccination in HIV Children
The purpose of this study is :
- To evaluate prevalence of protective hepatitis B antibody comparing intradermal (ID) and intramuscular (IM) route in antiHbsAb negative HIV infected children treated with highly active antiretroviral therapy (HAART)
- To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab
研究概览
详细说明
Hepatitis B virus (HBV) and HIV share the same route of transmission and can have co-infection. The prevalence of this co-infection was 8.7% in Thai adult[1, 2] and 12.1% in African HIV vertically transmitted children[3]. Occurrence of HBV has effects to treatment due to having the same medication, lamivudine, tenofovir, emtricitabine or entecavir, to anti HIV medication. HBV can cause chronic liver disease, cirrhosis and hepatocellular carcinoma.
In Thailand, the routine HBV vaccination program was started since 1992. Few reports in severe immune compromise HIV children has been shown to lose their expected preventive measles and hepatitis B antibody from history of scheduled vaccination even after the immune recovery by HAART[4, 5]. Limited data in of prevalence of protective hepatitis B antibody response after immune recovery in Thai HIV infected children treated with highly active antiretroviral therapy. In addition, HBV revaccination in this group of children should be considered[6].
The response of HBV revaccination intramuscularly (IM) at 0, 2 and 6 months in 63 HIV children shown response rates 17.4, 82.5, and 92.1% at 2, 6 and 7 months respectively[6]. Protective anti-HBs were shown in the majority of non-responders to IM HBV vaccine health care workers [21/23 (91.3%)] by two doses of intradermal route (ID)[7].
We hypothesize to see the faster and higher response of antiHBs after first dose of ID compare to IM in anti HBsAb negative HIV infected children. No randomized control trial compare antibody response between IM and ID route in HIV children after immune recovery. The benefit from this trial would be decreased the vaccine cost for resourced limited country.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Bangkok、泰国、10330
- HIV-NAT
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Bangkok、泰国、10330
- Pediatric infectious diseases section, King Chulalongkorn Memorial hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV infected individuals
- Age 1-18 years
- Current CD4 within 6 months ≥ 15% or ≥ 200 cells/ml in children age ≥ 6 years
- Signed written informed consent
- Negative HBs Ag, antiHBs, and antiHBc at screening visit
Exclusion Criteria:
- Active AIDS
- Active opportunistic infection
- Platelet < 50,000/ mm3 at screening visit
- History of hypersensitivity to HBV vaccine
- Using oral steroid or immunosuppressive drugs
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:1
HBV ID
|
Dosage: 2 microgram (mcg), 0.1 ml per dose Location: left deltoid area x 1 injection Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months |
有源比较器:2
HBV IM
|
Dosage: 2 microgram (mcg), 0.1 ml per dose Location: left deltoid area x 1 injection Common reactions: local pain, low grade fever, small hyperpigmented induration (granulomatous reaction) which may last up to 6-12 months |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Proportion of children with protective antiHBs at 8 weeks after first dose of HBV ID is superior to HBV IM
大体时间:8 weeks
|
8 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Proportion of children with positive antiHBs at 4 weeks after second and third dose of HBV
大体时间:4 weeks
|
4 weeks
|
Number of adverse events in HBV ID group and HBV IM group
大体时间:7 months
|
7 months
|
Proportion of protective antiHBs in HIV children after protocol defining immune recovery
大体时间:7 months
|
7 months
|
合作者和调查者
调查人员
- 首席研究员:Torsak Bunupuradah, MD、The HIV Netherlands Australia Thailand Research Collaboration
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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