| CTRI Number |
CTRI/2025/09/094396 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
07/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening |
| Study Design |
Other |
|
Public Title of Study
|
to check the protective antibody titre levels in actively participating already vaccinated dental studentsand check for the need of booster dose in health care workers
|
|
Scientific Title of Study
|
Seroprevalence of Anti- HBs titre levels in Hepatitis B vaccinated dental students. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eitisha Gupta |
| Designation |
PG trainee, OMFS. |
| Affiliation |
Meenakshi Ammal Dental College and Hospital, Chennai |
| Address |
Department of OMFS, Room no. 5, Meenakshi Ammal Dental College and Hospital, Chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
9340894761 |
| Fax |
|
| Email |
eitishachenu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Keerthana ponvel |
| Designation |
Assistant professor, OMFS. |
| Affiliation |
Meenakshi Ammal Dental College and Hospital, Chennai |
| Address |
Department of OMFS, Room no. 5, Meenakshi Ammal Dental College and Hospital, Chennai.
Department of OMFS, Room no. 5, Meenakshi Ammal Dental College and Hospital, Chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
9790885444 |
| Fax |
|
| Email |
drkeerthana.omfs@madch.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Eitisha Gupta |
| Designation |
PG trainee, OMFS. |
| Affiliation |
Meenakshi Ammal Dental College and Hospital, Chennai |
| Address |
Department of OMFS, Room no. 5, Meenakshi Ammal Dental College and Hospital, Chennai.
Chennai
TAMIL NADU
600095
India |
| Phone |
9340894761 |
| Fax |
|
| Email |
eitishachenu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal Dental college and hospital chennai (600095) , india |
|
|
Primary Sponsor
|
| Name |
Eitisha Gupta |
| Address |
Meenakshi Ammal Dental College And Hospital , chennai (600095), India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Eitisha gupta |
Meenakshi Ammal Dental College And Hospital chennai india |
Meenakshi Ammal Dental College And Hospital chennai india
department of oral and maxillofacial surgery, room number 5
Chennai
TAMIL NADU |
09340894761
eitishachenu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Meenakshi Ammal Dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants who had received primary vaccination of hepatitis B either in childhood or 5-6 yrs back.
participants who are healthy and have not suffered from hepatitis B in past |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
This is an observational study No intervention or comparator agent will be administered |
Participants will undergo a one-time blood sample collection (5 ml) for assessment of anti-HBs titre using chemiluminescence microparticle immunoassay (CMIA)No therapeutic or prophylactic intervention will be administered |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who have completed 3 doses of single-antigen recombinant hepatitis B vaccine,
usually administered on a 3-dose schedule at 0, 1, and 6 months.
Subjects who don’t give the history of hepatitis B exposure previously
Subjects who are willing to be the part of the study |
|
| ExclusionCriteria |
| Details |
subjects who have not previously been vaccinated with hepatitis B primary vaccination schedule
Subjects who are not willing to be the part of the study
Subjects with previous history of hepatitis B infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
If the level of anti HBs is greater than 10mIU/ml the subject
can be is considered to have seroprotective titres
of antibodies and no further hepatitis B vaccine
booster doses are required If the level of Anti
HBs is less than 10mIU/ml then subject is defined as
having suboptimal seroprotective titres of
antibodies and hepatitis B vaccine booster doses
are required |
If the level of anti HBs is greater than 10mIU/ml the subject
can be is considered to have seroprotective titres
of antibodies and no further hepatitis B vaccine
booster doses are required If the level of Anti
HBs is less than 10mIU/ml then subject is defined as
having suboptimal seroprotective titres of
antibodies and hepatitis B vaccine booster doses
are required |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| 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="0"
Months="2"
Days="10" |
|
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
|
The seroprevelance of anti-HBS titre in blood can be used to determine whether booster doses are necessary for people who are at high risk of contracting Hepatitis B infection, as the anti-HBS concentration in blood declines with age in those who have already received vaccinations. This study will be performed on 25 healthy postgraduate dental trainees of our institute who have completed 3 doses of single-antigen recombinant hepatitis B vaccine, usually administered on a 3-dose schedule at 0, 1, and 6 months. Postvaccination serologic testing for anti-HBs would be carried out for those subjects who have completed their 3-dose vaccine schedule at least 6 years prior to the present study and those who did not obtain a booster dose in the interim. Blood samples from these the study subjects will be drawn and levels of anti-HBs measured. Frozen separated serum samples will be sent to the same laboratory for testing anti-HBs level by chemiluminescence microparticle immunoassay (CMIA). Statistical analysis: A regression analysis will be performed between the titres levels of anti-HBs and the time interval from the last dose of hepatitis B vaccine This study will identify subjects with suboptimal seroprotective levels of anti-HBs antibody titres who will require a booster dose of hepatitis-B vaccine The results of the study would be especially relevant to dental healthcare personal who are highly vulnerable to HBV infection through high risk intra-oral surgical procedures that involve blood exposure with percutaneous puncture wounds from the use of scalpels, needles, dental wires and mucous membrane exposure of blood contaminated aerosol exposure through bone cutting and ultrasonic gingival scaling. Postvaccination serologic testing for antibody to hepatitis B surface antigen (anti-HBs) identifies vaccine nonresponders and guides the need for revaccination, additional testing for chronic HBV infection, and counseling for HCP who remain susceptible after failing to respond to vaccination. There are no risks with the study |