Efficacy and Safety of Accelerated Versus Standard Hepatitis B vaccination regimen among End Stage Renal Disease patients

Efficacy and Safety of Accelerated Versus Standard Hepatitis B vaccination regimen among End Stage Renal Disease patients: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210327001

Enrollment

132

Registered

2021-03-27

Start date

2021-05-31

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

HBV immunization in End Stage Renal Disease HBV immunization in End Stage Renal Disease

Interventions

HBV Vaccination 40 mcg IM x 4 times at day0, week 1, week 4 and week 8,HBV Vaccination 40 mcg IM x 4 times at day0, month 1, month 2 and month 6

Experimental Biological/Vaccine,Active Comparator Biological/Vaccine

Accelerated regimen,Standard regimen

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ESRD patients Undetectable AntiHbS

Exclusion criteria

Exclusion criteria: History of allergic adverse effects with others vaccine Patients with immunosuppressive drugs AntiHIV positive Anti HbC positive Recent Tetanus-diptheria(Td) vaccine Refusal to give inform consent

Design outcomes

Primary

Measure	Time frame
Seroconversion rate at 3 month at 3 month after the first dose vaccination Rate	—

Secondary

Measure	Time frame
Seroconversion rate at 7,12 month at 7,12 months after the first dose vaccination rate,AntiHbS GMT titer at 3,7,and 12 month at 3,7, and 12 months after the first dose vaccination numerical value,Compliance at 7 months after the first dose vaccination rate,Adverse reaction at 12 month after the first dose vaccination rate	—

Countries

Thailand

Contacts

Public ContactJathurong Kittrakulrat

Internal Medicine Department, Chulalongkorn University

j.kittrakulrat@gmail.com0819497487

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026