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CTRI Number  CTRI/2024/07/070546 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening 
Study Design  Other 
Public Title of Study   Anti-HBs Antibody Titres among healthcare workers vaccinated against Hepatitis B in AIIMS Rajkot 
Scientific Title of Study   Evaluation of Anti-HBs Antibody Titres and assessing the Immune Response among healthcare workers vaccinated against Hepatitis B in AIIMS Rajkot 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mayuri Bhise 
Designation  Assistant professor  
Affiliation  AIIMS Rajkot 
Address  Department of Microbiology IPD Campus Kandhari Parapipaliya AIIMS Rajkot Gujarat

Rajkot
GUJARAT
360001
India 
Phone  8698515145  
Fax    
Email  mayuri.umrao@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayuri Bhise 
Designation  Assistant professor  
Affiliation  AIIMS Rajkot 
Address  Department of Microbiology IPD Campus Kandhari Parapipaliya AIIMS Rajkot Gujarat

Rajkot
GUJARAT
360001
India 
Phone  8698515145  
Fax    
Email  mayuri.umrao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mayuri Bhise 
Designation  Assistant professor  
Affiliation  AIIMS Rajkot 
Address  Department of Microbiology IPD Campus Kandhari Parapipaliya AIIMS Rajkot Gujarat

Rajkot
GUJARAT
360001
India 
Phone  8698515145  
Fax    
Email  mayuri.umrao@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Rajkot PArapipaliya Khandheri Rajkot Gujarat 360110 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Rajkot  
Address  All India Institute Of Medical Sciences, Parapipaliya Khandheri Rajkot Gujarat 360110 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mayuri Bhise  All INDIA INSTITUTE OF MEDICAL SCIENCES RAJKOT  Department of Microbiology Central Laboratory Complex IPD Block AIIMS RAJKOT 360001
Rajkot
GUJARAT 
8698515145

mayuri.umrao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee AIIMS Rajkot   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Vaccinated health care workers as health volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AntiHBs Antibody Titre by ELISA determination in vaccinated health care workers   2 YEARS WITH 6 MONTHS FREQUENCY  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
5) Regular full-time working employees are not willing to participate and give consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the optimal immune response (IR) among vaccinated healthcare workers for Hepatitis B
To identify the non-responders among the vaccinated healthcare workers

 
6 months

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the optimal immune response (IR) among vaccinated healthcare workers for   6 months 
 
Target Sample Size   Total Sample Size="313"
Sample Size from India="313" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

5) 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.

 
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