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Hepatitis B vaccine administration among HIV infected individuals

Comparative study of effectiveness of â??standardâ?? versus â??acceleratedâ?? schedule and standard dose versus double dose of recombinant Hepatitis B vaccine among HIV positive adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/08/003942
Enrollment
760
Registered
2013-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- HIV infected adult individuals

Interventions

Intervention1: Accelerated schedule ( 0,1,2 and 6 month): HBV vaccine administered at Accelerated schedule ( 0,1 and 6 month) with standard dose and double dose. Control Intervention1: Standard schedu

Sponsors

Calcutta School of Tropical Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) HIV seropositive patients above 20 years enrolled in the national ART Programme (Pre- ART & ART) as per NACO guideline. 2) Negative for any HBV serological marker. 3) Without any history of previous hepatitis B vaccination. 4) Willing to give written informed consent (by self).

Exclusion criteria

Exclusion criteria: 1. Currently positive for pregnancy test. 2. Associated life-threatening disease 3. Presence of any malignancy 4. Presence of associated co-infection with HCV, HAV or HEV.

Design outcomes

Primary

MeasureTime frame
HBV vaccination induced seroconversion rate will be higher for the accelerated schedule (0, 1, 2 and 6 month) than standard schedule (0, 1 and 6 month)and for the Double dose than standard dose.Timepoint: HBV vaccination induced seroconversion rate will be higher for the accelerated schedule (0, 1, 2 and 6 month) than standard schedule (0, 1 and 6 month)and for the Double dose than standard dose.

Secondary

MeasureTime frame
HBV seroconversion rate may be associated with high HIV viral load and low CD4 countTimepoint: CD4 count and HIV viral load measured before first dose of HBV vaccine.

Countries

India

Contacts

Public ContactSubhasish Kamal Guha

Calcutta School of Tropical Medicine

drskguha@gmail.com03322123704

Outcome results

None listed

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