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ANTIBODY TITRE DEVELOPMENT FOLLOWING ACCELERATED AND STANDARD HEPATITIS B VACCINATION SCHEDULE

COMPARATIVE STUDY OF IMMUNOGENICITY DEVELOPED FOLLOWING STANDARD AND ACCELERATED HEPATITIS B VACCINATION SCHEDULES

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049966
Enrollment
70
Registered
2023-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: ACCELERATED HEPATITIS B VACCINE (GeneVac-B) SCHEDULE: HEPATITIS B VACCINE (GeneVac-B), 1ml intramuscular (preferably on left deltoid) given on day 0, day 10, day 21. Control Interventi

Sponsors

SCHOOL OF TROPICAL MEDICINE
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
complianceTimepoint: accelerated schedule: at 2 month standard schedule: at 7 months

Countries

India

Contacts

Public ContactDr RUCHA KARAD

SCHOOL OF TROPICAL MEDICINE

s_bibhuti@hotmail.com9831296071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026