Comparative effectiveness of standrad versus double doses of hepatitis B vaccine in patients with chronic kidney disease
Phase 3
- Conditions
- Health Condition 1: N184- Chronic kidney disease, stage 4 (severe)
- Registration Number
- CTRI/2024/02/063054
- Lead Sponsor
- Amit Goel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. people with chronic kidney disease with estimated GFR between 60 and 15 ml per min
2. who are not on maintenance hemodialysis (MHD)
3. age between 19 and 65 years
4. are unlikely to need MHD in next 18 months
5. not received hepatitis B vaccination
6. HBsAg and anti-HBs antibody negative
7. body mass index (BMI) more than 18.5 Kg per M2
Exclusion Criteria
1. Hepatitis C virus or HIV coinfection
2. Post-organ transplant recipients
3. On immunosuppressive medication, regardless of indication
4. Any immunodeficiency conditions
5. Presence of malignancy, regardless of its nature and stage of disease
6. Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients who could achieve sero-protection, i.e. achieved anti-HBs titer =10 mIU per mL, following four standard (1.0 ml) or double (2.0 ml) doses of hepatitis B vaccineTimepoint: 4-12 weeks after the administration of fourth dose of the vaccine
- Secondary Outcome Measures
Name Time Method Compare the geometrical mean titer of anti-HBs antibody achieved after four standard or double doses of hepatitis B vaccine in those who could achieve seroprotectionTimepoint: 4-12 weeks after the administration of fourth dose of the vaccine;Compare the proportion of patients who could achieve sero-conversion (anti-HBs antibody detected) after four standard (1.0 ml) or double (2.0 ml) doses of hepatitis B vaccineTimepoint: 4-12 weeks after the administration of fourth dose of the vaccine;Compare the qualitative and quantitative durability of vaccine induced antibody response (seroprotection as well as anti-HBs titer) at one year from the administration of first dose of the vaccine.Timepoint: 12 to 15 months after the administration of first dose of vaccine;Identify the risk factors associated with poor vaccine response (seroconversion, seroprotection)Timepoint: 4-12 weeks after the administration of fourth dose of the vaccine