Seroprevalence of Anti- HBs titre levels in Hepatitis B vaccinated dental students.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- If the level of anti HBs is greater than 10mIU/ml the subject
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 10.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
If the level of anti HBs is greater than 10mIU/ml the subject
Time Frame: 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
can be is considered to have seroprotective titres
Time Frame: 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
of antibodies and no further hepatitis B vaccine
Time Frame: 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
booster doses are required If the level of Anti
Time Frame: 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
HBs is less than 10mIU/ml then subject is defined as
Time Frame: 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
having suboptimal seroprotective titres of
Time Frame: 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
antibodies and hepatitis B vaccine booster doses
Time Frame: 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
are required
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Eitisha Gupta
Meenakshi Ammal Dental College and Hospital, Chennai