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ANTIBODY TITRE DEVELOPMENT FOLLOWING ACCELERATED AND STANDARD HEPATITIS B VACCINATION SCHEDULE

Phase 4
Registration Number
CTRI/2023/02/049966
Lead Sponsor
SCHOOL OF TROPICAL MEDICINE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Age more than 18 years and of all genders.

Hepatitis B vaccine naïve persons

People living with HIV attending out-patient department, ART centre

Family members of patients attending hepatitis clinic at school of tropical medicine.

Exclusion Criteria

People with known hepatitis B virus infection.

People with chronic kidney disease.

People with malignancy or on chemotherapy.

People with diagnosed autoimmune disease.

People with severe HIV infection (WHO stage 3 and stage 4 disease), with CD4 count less than 200.

People on steroids for more than 4 weeks or on any immunomodulator therapy.

People received immunoglobulin in last 3 months.

People having history of allergy to any vaccine or vaccine compound

People with age more than 60 years

Patients suffering from any acute illness

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To see development of immunogenicity i.e., Anti HBs antibody titre following classical hepatitis B vaccine schedule (0,1-month,6 month) and accelerated hepatitis B vaccine schedule (0, day 10, day 21)Timepoint: Anti HBs antibody titre will be done at baseline,2 month (only for accelerated schedule), 7 month following 1st dose of vaccine
Secondary Outcome Measures
NameTimeMethod
complianceTimepoint: accelerated schedule: at 2 month <br/ ><br>standard schedule: at 7 months
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