Hepatitis B vaccine in patients with chronic kidney disease
Phase 3
Suspended
- Conditions
- Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)
- Registration Number
- CTRI/2022/07/044007
- Lead Sponsor
- Indian Council of Medical Research ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
(i) Adults of between 19-45 years of age
(ii) Who are unlikely to need MHD in next one year
(iii) Not had ever received hepatitis B vaccination, as suggested by history
(iv) HBsAg negative
(v) Body mass index (BMI) between 18.5-25 Kg/m2
Exclusion Criteria
(i) Hepatitis C virus or HIV coinfection
(ii) Post-renal or other organ transplant recipients
(iii) On immunosuppressive medication, regardless of indication
(iv) Any chronic immunodeficiency condition
(v) Presence of malignancy, regardless of its nature and stage of disease
(vi) Presence of autoimmune condition
(vii) active alcohol intake or current smoker
(viii) Smoking or alcohol intake till recent past ( <6months)
(ix) Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of of participants who achieve seroconversion after vaccinationTimepoint: 4-12 weeks after the last dose of vaccine administration
- Secondary Outcome Measures
Name Time Method To compare the mean serum anti-HBs titer between the two groups after the first, second, third and fourth doses of vaccine <br/ ><br> <br/ ><br>Timepoint: 4-6 weeks after first, second, and third doses whereas 4-12 weeks after the fourth dose of vaccine