Susceptibility to Hepatitis B in Neonates Given Birth Dose; Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Sero-proetction Level
研究概览
简要总结
With 2.5% prevalence in general population, Pakistan is an intermediate endemicity country for hepatitis B. However, wide disparity exists across the country as disease prevalence in general population soars as high as 14% in hyper endemic areas. This hyper endemicity increases the risk of acquiring infection via vertical and horizontal routes of disease transmission. National immunization schedule in Pakistan administers the first vaccine against hepatitis B at 6th week after infant birth. Owing to this 6 week interlude the existing immunization schedule may not provide adequate protection to a newborn against the disease. A monovalent hepatitis B vaccination shot, administered within 12 hours of birth, is the preferred strategy for disease control in hyper endemic areas. The National Immunization Technical Advisory Groups around the world are expected to use rigorous scientific evidence and make changes in the immunization schedule and vaccine dosage, responding to the evolving epidemiology of childhood diseases. Such research on local evidence for hepatitis B vaccine in Pakistan is not available and our research fills this gap by This research studied the hepatitis B vaccine response, in two cohorts of healthy infants. An open labeled, randomized controlled, non-inferiority, vaccine trial methodology was used. Margin of non non-inferiority (Δ) was set at 5%. The trial administered hepatitis B birth dose as an intervention and vaccination done under the national immunization schedule was taken as standard of care.
详细描述
Study Design:
The study is an unblinded, open-labeled, non-inferiority, randomized controlled trial with a participant ratio of 1:1 in each group (the design remained the same through the length of the study and no changes were made to the methods approved in the protocol). The reason for making the study as an open labeled trial is that mothers could not feasibly be blinded from the information on allocation scheme, and the information on vaccine given to infants could not be held back from family and parents. Another non-inferiority vaccine trial in Pakistan also used a similar approach in allocation scheme Trial Profile The trial was done at a tertiary care hospital in an urban area from March 15, 2015, to May 20, 2016. Assuming an attrition rate of 25%, the study enrolled 296 expectant mothers for allocation in two groups, intervention, and control group.
Participants of the trial:
The study population was healthy newborns born to healthy females, in a health facility. These pregnant women were registered for institutional deliveries at Countess Dufferin Fund (CDF) Hospital, Hyderabad. The CDF Hospital Hyderabad is a tertiary care hospital for women and children. The hospital is located in a populous downtown area of the Hyderabad city and caters to patients coming from the urban areas of the city. The average daily out-patient visits to the hospital are 200 women. The average number of daily deliveries in the hospital is 25.
All women who attended an antenatal clinic for a routine examination by gynecologist were evaluated on following inclusion criteria;
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
- None
入排标准
- 年龄范围
- 12 Hours 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn with weight more than 2000 grams
- •Born to health mothers
- •No sign of congenital disease
排除标准
- •Low birth weight newborn
- •Signs and Symptoms of febrile Illness/sepsis
- •Congenital Malformation
- •Signs of Cyanosis
- •Difficulty in breathing
结局指标
主要结局
Sero-proetction Level
时间窗: 8 weeks after third pentavalent vaccination
The outcome of the study is the measurement of seroprotection correlates against hepatitis B, i.e., anti-hepatitis B surface antigen antibody titer
次要结局
- Adverse event(96 hours after the administration of hepatitis B birth dose)
研究者
Zulfikar Gorar
Ph. D (Public Health Student)
Quaid-e-Azam University