Comparative effectiveness of standrad versus double doses of hepatitis B vaccine in patients with chronic kidney disease

Double-blind, placebo-controlled, randomized trial to compare antibody response to four standard- versus double-dose schedule of hepatitis B vaccine in pre-dialysis patients with eGFR <60 ml/min - None

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063054

Enrollment

400

Registered

2024-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N184- Chronic kidney disease, stage 4 (severe)

Interventions

Intervention1: Intervention arm: Each participant will be given 1.0 ml vaccine and 1.0 ml sterile normal saline as placebo intramusculalrly at 0,1, 2 and at 6 months. In one ml of vaccine contain 20 m

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactAmit Goel

Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)

agoel.ag@gmail.com919936275741

Outcome results

None listed

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