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临床试验/CTRI/2024/07/070546
CTRI/2024/07/070546尚未招募不适用

Evaluation of Anti-HBs Antibody Titres and assessing the Immune Response among healthcare workers vaccinated against Hepatitis B in AIIMS Rajkot

All India Institute Of Medical Sciences Rajkot1 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2024年7月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
313
试验地点
1
主要终点
To assess the optimal immune response (IR) among vaccinated healthcare workers for Hepatitis B

研究概览

简要总结

Globally, Hepatitis B virus (HBV) infection is a pressing health concern, affecting an estimated 257 million individuals. In the WHO South-East Asia Region, approximately 2% of the general population is infected with hepatitis B. India, situated in the intermediate endemic zone, has the world’s second-largest number of hepatitis B cases. It is estimated that between 2%-8% of individuals in India carry the hepatitis B surface antigen (HBsAg), resulting in over 50 million cases. Additionally, nursing officers are at high risk for occupational exposure to hepatitis B due to its prevalence and ability to be transmitted through blood during patient care. Although implementing infection control measures can help mitigate risks, HBV remains highly infectious and can even be transmitted without visible blood. Furthermore, it can survive on surfaces for up to seven days. Despite efforts to address this issue through protocols, occupational exposure to HBV remains a significant concern.

By ensuring HBV protection for nursing staff, this project addresses an essential aspect of occupational health within healthcare settings. This intramural project could lead to significant improvements in staff safety and contribute to broader public health goals if it analyzes anti-HBs antibody titers, assesses immune responses, and identifies non-responders among vaccinated nursing staff.

Study design: Cross-sectional study

Study duration: -All samples collected from regular full-time working employees for 24 months

Study Setting: -The study will be conducted in the Serology section of the Department of Microbiology, AIIMS Rajkot

Study Population: - The target population will be regular full-time healthcare workers working in AIIMS Rajkot who have completed a course of Hepatitis B vaccination (n=313)

Inclusion criteria

1   All healthcare workers who are regular employees and who have received a complete course of the Hepatitis B vaccine

 2.  All healthcare workers who gave valid consent for participation

 Exclusion criteria:

  1. All healthcare workers who are regular employees and who are non-vaccinated against Hepatitis B

  2. All those employees who have a positive history of HBV infection in the past

  3. Regular full-time working employees are not willing to participate and give consent.

Methodology A cross-sectional survey will be conducted to gather information from regular working  employees who have received at least one complete course of the Hepatitis B vaccine and are volunteering to participate. Once written consent is obtained, an investigator will explain the study’s objectives. Participants’ personal histories will be obtained using a standardized questionnaire. This will include demographic information such as age, gender, occupation, and details about their hepatitis B vaccination and any previous needle stick injuries. Blood samples (5ml) will be collected using aseptic techniques and labeled accordingly for serum separation. The level of anti-HBs antibodies in the serum will be determined using ELISA following the manufacturer’s instructions. According to the Centers for Disease Control and Prevention guidelines, a quantitative anti-HBS level below 10.0 mIU/ml will indicate an inadequate immune response to HBV vaccination.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • All healthcare workers who are regular employees and who have received a complete course of the Hepatitis B vaccine
  • All healthcare workers who gave valid consent for participation.

排除标准

  • All healthcare workers who are regular employees and who are non-vaccinated against Hepatitis B 2) All those employees who have a positive history of HBV infection in the past 5) Regular full-time working employees are not willing to participate and give consent.

结局指标

主要结局

To assess the optimal immune response (IR) among vaccinated healthcare workers for Hepatitis B

时间窗: 6 months

To identify the non-responders among the vaccinated healthcare workers

时间窗: 6 months

次要结局

  • To assess the optimal immune response (IR) among vaccinated healthcare workers for(6 months)

研究者

发起方
All India Institute Of Medical Sciences Rajkot
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mayuri Bhise

AIIMS Rajkot

研究点 (1)

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