A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 504
- 试验地点
- 40
- 主要终点
- Infant hepatitis B infection status
研究概览
简要总结
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.
详细描述
This is a prospective multi-center, multi-country (Thailand and Lao PDR), open-label, single arm clinical trial in HBsAg and HBeAg positive pregnant women (from 28 weeks until one year postpartum) and their infants (until 18 months of age). Pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate 300 mg once daily from 28 weeks of pregnancy until two months postpartum. Their infants will receive hepatitis B (HB) immunization, starting with the first dose soon after birth.
The study aims to show that substituting maternal antiviral treatment for infant HBIg can be favorably considered in settings where HBIg plus vaccine has been used as well as in settings where only vaccine is used. A significant improvement over the standard HBIg + vaccine strategy would be that adding an antiviral strategy results in less than 2% transmission. A total of 499 women and their infants will be enrolled in public hospitals in Thailand and Lao PDR.
The study will be monitored by a Data and Safety Monitoring Board (DSMB) at least annually.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy
- •Age ≥18 years
- •Negative HIV antibody test during current pregnancy
- •Positive HBsAg test during current pregnancy
- •Positive HBeAg using a rapid test during current pregnancy
- •Absence of clinical symptoms of liver disease
- •Gestational age of 28 weeks (+/- 7 days) based on the obstetrician judgment guided by the review of the date of last menstruation period.
- •Willing and able to provide written informed consent
- •Agreeing to bring her infants(s) at the planned study visits at one of the study site until the last visit (18 months after birth) and to inform the site investigators if plans to move to another place and not be able to return to the clinic
- •Understand the need for adequate infant immunization for her infant(s) and accept that blood draws will be performed to determine the infant HBV infection status
排除标准
- •Receipt of anti-HBV antivirals at any time during the last 9 months
- •Known liver cirrhosis or evidence of hepatocellular carcinoma
- •Creatinine clearance <50 ml/min, calculated using the Cockcroft-Gault formula
- •Confirmed dipstick proteinuria >1+ (>30 mg/dL) or normoglycemic glycosuria
- •Evidence of pre-existing fetal anomalies incompatible with life
- •Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or compromise adherence to treatment and satisfactory follow up in the study.
结局指标
主要结局
Infant hepatitis B infection status
时间窗: Six months of age
HBsAg positive confirmed by PCR detection of HBV DNA.
次要结局
- Preterm live births(Delivery)
- Maternal HBV DNA changes(From enrollment until end of study treatment scheduled 2 months after delivery)
- Infant levels of anti-HBs antibodies(At 1, 2, 4, 6, and 12 months of age)
- HBV infection status in all infants regardless of maternal response to study treatment(At 6 months of age)
- Serious adverse events(From birth until 12 months of age)
- Low birth weight(Delivery)
- Active or previous transient infection in children(At 18 months of age)
研究者
GONZAGUE JOURDAIN
Researcher
Institut de Recherche pour le Developpement