Hepatitis B vaccination in hemodialysis patients

An open label, non-inferiority randomized controlled trial of intradermal versus intramuscular administration of Hepatitis B vaccine in failed response to previous standard intramuscular schedule of Hepatitis B vaccination in patients of end stage renal disease on haemodialysis. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/02/081059

Enrollment

112

Registered

2025-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Hepatitis B vaccine [ID]: 10 micro gram (0.5 ml) of Hepatitis B vaccine will be administered to the enrolled patients by trained qualified personnel intradermally at week 0, 1, 2, 3, 4,

Eligibility

Inclusion criteria

Inclusion criteria: Chronic kidney disease patients on MHD for a minimum of 3 months with age 18 years or above. Have undergone a complete previous primary series of IM double dose vaccination i.e. 40 microgram of recombinant hepatitis B vaccine at 0, 1, 2 and 6 months after initiation of hemodialysis. Previously vaccinated patients who currently have Anti-HbsAb titres less than 10mIU/ml. Patients on regular follow up and complete records. Patients agreeing to participate in this study by signing informed consent forms.

Exclusion criteria

Exclusion criteria: CKD patients not on maintenance haemodialysis or on peritoneal dialysis. Patients eligible for renal transplant within next 6 months. Patients with anti-HBs antibody titres greater than 10 mIU/mL. Patients found to be HbsAg positive Vaccinated with any other vaccine within 2 weeks. Patients who have been administered a booster dose of Hep B vaccine irrespective of timeline. Patients not willing to participate in the study. Pregnant or breastfeeding females.

Design outcomes

Primary

Measure	Time frame
To compare the responses i.e. anti-HBsAb titres greater than 10 mIU/ml between IM and ID vaccination arms in patients with a failed response to primary Hep B vaccination. To compare the development of protective responses i.e. anti-HBsAb titres greater than 100 mIU/ml between IM and ID vaccination arms in patients with a failed response to primary Hep B vaccination. Timepoint: 12 months	—

Secondary

Measure	Time frame
To assess the change in titres at predefined time points prior to completion of vaccination schedule i.e at Week 4 for ID and Month 3 for IM and at Week 12 for ID and Month 7 for IM. To determine factors affecting response to vaccination. Timepoint: 12 months	—

Countries

India

Contacts

Public ContactDr Sayali Thakare

Seth GSMC & KEM Hospital

tukaramjamale@yahoo.co.in9167460362

Outcome results

None listed

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