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Comparison between two schedules of giving Hepatitis B immunisation in unimmunised HIV-positive children.

Three Dose vs Four Dose Schedule of Double Dose Recombinant Hepatitis B Vaccine in HIV-infected Children - RACE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010816
Enrollment
50
Registered
2017-12-07
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 children aged 18 months to 12 years

Interventions

Intervention1: Recombinant Hepatitis B vaccine (20mcg) IM at 0,1,6 months: Intervention group will receive vaccine in 3 dose schedule at 0,1,6 months Control Intervention1: Recombinant Hepatitis B vac

Sponsors

University College of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: HIV positive children receiving ART, who have not received any immunisation against Hepatitis B

Exclusion criteria

Exclusion criteria: Children who are Hepatits B surface antigen positive, suffering from Hepatitis C and immunological failure

Design outcomes

Primary

MeasureTime frame
Anti HBs titres in both groups after completion of primary immunization scheduleTimepoint: 7 months after first dose of recombinant Hepatitis B vaccine—

Secondary

MeasureTime frame
1 Proportion of good responders in both groups 2 Proportion of non-responders in both groups 3 Anti HBs titres at 12 months in both groups Timepoint: 12 months after receiving the first dose of recombinant hepatitis B vaccine in both groups; 3 months after thr first dose of hepatitis B vaccine in 4 dose vaccine group—

Countries

India

Contacts

Public ContactPrachi Jain

Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital

poojadewan@hotmail.com9811411376

Outcome results

None listed

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