Influence of Delayed Vaccination of Hepatitis B Vaccine on Vaccination Safety and Immune Response of Newborns After Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Adverse reactions
研究概览
简要总结
At present, whether the hepatitis B vaccine (HBV) can be vaccinated on time after neonatal surgery has become a common problem for children's families, neonatal surgeons, and vaccination departments, but there are few relevant studies at home and abroad, and there is no corresponding guide or consensus. In the early stage, our research team investigated the vaccination plans of the vaccination units in the main urban areas of Chongqing for such children through telephone follow-up, and found that the practices of each unit were different, all based on their own experience, and there was no clear evidence to support the vaccination or should not be vaccinated, which may cause some children to miss the best vaccination time or increase the risk of vaccination. The center is a relatively large neonatal surgery center in southwest China. The diagnosis and treatment of neonatal digestive tract malformations is at the leading level in China. It can carry out various neonatal operations such as neonatal necrotizing enterocolitis, congenital anorectal malformations, and congenital megacolon. On average, it carries out more than 30 third and fourth grade neonatal gastrointestinal operations every month. It has accumulated a lot of experience in the follow-up of newborns, There is a large amount of clinical data support for children who need to be vaccinated after surgery, so it is planned to follow up the second and third doses of hepatitis B vaccine and whether there are adverse reactions related to vaccination for children who need to be vaccinated after gastrointestinal surgery in the neonatal period, and at the same time check the production of HBsAb after vaccination, The immune response and adverse reactions of hepatitis B vaccine at different time points after surgery were studied to increase clinical evidence for the determination of hepatitis B vaccine vaccination program for newborns after surgery.
详细描述
Research design
- Selection of research objects (research population)
Newborns who were screened in the department and met all of the following criteria were included in this study: 1) term infants and the first dose of hepatitis B vaccine had been vaccinated on time; 2) Children with indications for staged gastrointestinal surgery, and the first operation should be performed within 28 days after birth; 3) The child has no immune system disease or serious development defect or dysfunction of heart, brain, liver, kidney and other organs; 4) HBsAg - before initial operation; 5) Prenatal HBsAg - detection of the mother or father of the child; 6) The guardian signed the informed consent form and agreed to participate in the study. Exclusion criteria: 1) premature infants; 2) The first operation time exceeds 28 days after birth; 3) There are serious developmental malformations or dysfunction of heart, brain, liver, kidney and other organs or immune system diseases; 4) The patient or one of his parents is HBsAg+; 5) Children who are allergic to hepatitis B vaccine or have other serious adverse reactions; 6) Children interviewed by vector.
The end point of the study is 6 years after joining the group. Two mid-term evaluations will be conducted one year and two years after the start of the study. This project will apply for funding until the mid-term evaluation of the first year. The follow-up research funds will be supported by the follow-up projects or self raised funds. The criteria for withdrawal from the cohort were: during the study period, the children were infected with hepatitis B virus due to other reasons such as "surgery, blood transfusion, trauma", or diagnosed with immune related diseases during the follow-up period.
- Patient grouping
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term neonates;
- •Underwent staged gastrointestinal surgery;
- •No immune system disease; 5.no serious defect of heart, brain, liver, kidney and other organs.
排除标准
- •Having immune system diseases;
- •Having serious defect of heart, brain, liver, kidney and other organs;
- •Lost patients.
结局指标
主要结局
Adverse reactions
时间窗: 2 years
Whether there are vaccine related adverse reactions after vaccination: fever, urticaria, local pain, erythema, induration, atc.
Immune effect of vaccine
时间窗: up to 2 years
Results of hepatitis B surface markers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) at the age of 1 and 2
Prenatal hepatitis B surface markers
时间窗: 1 month
Prenatal hepatitis B surface makers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) of mothers and childrens. Measurement of relevant indicators using Roche chemiluminescence method.
Newborn condition
时间窗: 1 month
Surface markers of hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) in newborn.
Vaccination time
时间窗: up to 2 years
Time for subjects to receive three doses of hepatitis B vaccine
次要结局
未报告次要终点
研究者
Hanbin Zhao
Principal Investigator
Children's Hospital of Chongqing Medical University