Comparison of protection against Hepatitis B offered by increased doses of vaccine versus standard doses in children with chronic kidney disease
Phase 4
- Conditions
- Health Condition 1: N18- Chronic kidney disease (CKD)
- Registration Number
- CTRI/2024/03/063531
- Lead Sponsor
- Adarsh Vijayakumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children with chronic kidney disease stage 2-5D aged 2-18 years with anti-HBsAg antibody titers < 10 mIU/
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children seroprotected (Anti-HBsAg titers 10 mIU/mL) between children who received the standard dose versus the augmented doseTimepoint: At Enrollment, <br/ ><br>1-2 months after completion of vaccine course, i.e, 7-8 months from enrollment
- Secondary Outcome Measures
Name Time Method 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