Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)
Conditions
Interventions
Intervention1: HepB Vaccine 2.0: Four doses of recombinant hepatitis B vaccine, 2.0 ml each, administered intramuscularly at 0, 1, 2, and 6 months.
Control Intervention1: HepB vaccine 1.0: Four doses
Sponsors
Indian Council of Medical Research ICMR
Eligibility
Inclusion criteria
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
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 ( (ix) Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of of participants who achieve seroconversion after vaccinationTimepoint: 4-12 weeks after the last dose of vaccine administration | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the mean serum anti-HBs titer between the two groups after the first, second, third and fourth doses of vaccine Timepoint: 4-6 weeks after first, second, and third doses whereas 4-12 weeks after the fourth dose of vaccine | — |
Countries
India
Contacts
Public ContactAmit Goel
Sanjay Gandhi Postgraduate Institute
Outcome results
None listed