| 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
|
|
|
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
|
|
|
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. |