Comparison of protection against Hepatitis B offered by increased doses of vaccine versus standard doses in children with chronic kidney disease

Seroprotection after standard dose (10 mcg) versus augmented dose (20 mcg) hepatitis B vaccine in children and adolescents with chronic kidney disease stage 2-5D: a randomized controlled trial.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063531

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: N18- Chronic kidney disease (CKD)

Interventions

Intervention1: Hepatitis B vaccine 20 mcg: Group B shall receive augmented dose Hepatitis B vaccination dose, intramuscular route [20 µg at 0,1 and 6 months]. Control Intervention1: Hepatitis B vaccin

Eligibility

Inclusion criteria

Inclusion criteria: Children with chronic kidney disease stage 2-5D aged 2-18 years with anti-HBsAg antibody titers < 10 mIU/L

Exclusion criteria

Exclusion criteria: Patients with an HBsAg positive report, Patients who received monoclonal antibodies within 9 months, Patients who have received IVIG in the past 3 months

Design outcomes

Primary

Measure	Time frame
Proportion of children seroprotected (Anti-HBsAg titers 10 mIU/mL) between children who received the standard dose versus the augmented doseTimepoint: At Enrollment, 1-2 months after completion of vaccine course, i.e, 7-8 months from enrollment	—

Secondary

Measure	Time frame
To compare antibody titers among CKD children who are receiving immunosuppressive medication versus those who are not receiving themTimepoint: 2 years;To compare the antibody titers among pre-dialysis CKD versus those on dialysisTimepoint: 2 years;To compare the antibody titers among the different stages of CKDTimepoint: 2 years	—

Countries

India

Contacts

Public ContactDr Bobbity Deepthi

JIPMER Puducherry

deepu.reddy222@gmail.com9999236415

Outcome results

None listed

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