Study on Hepatitis B vaccine dosage on children with chronic kidney disease

To compare efficacy and safety of double dose versus standard dose of hepatitis B vaccine in non-dialyzed children with chronic kidney disease (CKD): A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014435

Enrollment

Registered

2018-06-06

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- children with chronic kidney disease

Interventions

Intervention1: Standard dose of hepatitis B vaccine: Standard dose which is 10 microgram of hepatitis B vaccine Control Intervention1: Double dose pf hepatitis B vaccine: Double dose which is 20 micro

Eligibility

Inclusion criteria

Inclusion criteria: All children with diagnosis of CKD stage 2-5 between 1-14 years of age with anti-HBs titer <10 mIU/mL.

Exclusion criteria

Exclusion criteria: 1.Documented history of previous HBV infection or laboratory markers of present or past HBV infection 2.Children with known adverse immune reaction to vaccine. 3.Children on immunosuppressive agents.

Design outcomes

Primary

Measure	Time frame
To compare seroconversion rate (anti-HBs titer10mIU/mL) with two different doses of recombinant HB vaccine in non-dialyzed children with CKD stage 2-5, receiving 20 mcg (double dose) versus 10 mcg (standard dose) HB vaccine administered at 0,1 and 6 months.Timepoint: 0,1,6 and 7 months	—

Secondary

Measure	Time frame
1. To compare seroconversion rate according to various stages of CKD (stage 3-5) in both the intervention groups. 2. To compare anti-HBs titer between the two groups. 3. To compare adverse effects; like local reaction, systemic reaction or anaphylaxis in two groups. 4. To assess factors determining seroconversion rate like, age, gender, stage of CKD, anemia, malnutrition, serum albumin, serum PTH and serum vitamin D level. Timepoint: 0,1,7 and 7 month	—

Measure

Time frame

1. To compare seroconversion rate according to various stages of CKD (stage 3-5) in both the intervention groups. 2. To compare anti-HBs titer between the two groups. 3. To compare adverse effects; like local reaction, systemic reaction or anaphylaxis in two groups. 4. To assess factors determining seroconversion rate like, age, gender, stage of CKD, anemia, malnutrition, serum albumin, serum PTH and serum vitamin D level. Timepoint: 0,1,7 and 7 month

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Countries

India

Contacts

Public ContactDr Harshit Kumar

Chacha Nehru Bal Chikitsalaya, Geeta colony, Delhi

manishkp75@yahoo.com09899023635

Outcome results

None listed

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