efficacy of Double dose versus Single dose of Hepatitis B vaccination in patients with inflammatory bowel disease

Efficacy of high dosage of hepatitis B vaccination compared to standard dose in patient with inflammatory bowel disease: randomized controlled trial

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/043713

Enrollment

Registered

2022-07-05

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

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

Conditions

Health Condition 1: K508- Crohns disease of both small andlarge intestine Health Condition 2: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: High dose (double dose, 40mcg) Hepatitis B vaccine: Double dose of hepatitis B vaccine will be given at 0, 1 , and 6 months. Control Intervention1: Standard dose (20 mcg) of Hepatitis B

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of IBD (established by standard clinical, radiographic, endoscopic and histological criteria). 2. Age >=18 years at the time of the first administration of the vaccine 3. Seronegativity for hepatitis b surface antigen (HBsAg), antibodies to hepatitis B core protein (anti-HBc) 4. No history of prior hepatitis b vaccination and titers for antibodies to hepatitis B surface antigen

Exclusion criteria

Exclusion criteria: 1. History of HBV infection 2. Previous vaccination against HBV (regardless of response) 3. Any medical condition known to cause immunosuppression e.g. human immunodeficiency virus (HIV) infection, chronic kidney disease or malignancy 4. Pregnant or lactating women 5. Liver cirrhosis

Design outcomes

Primary

Measure	Time frame
â?¢To assess the adequate immune response (antiHBs antibody titer 10 IU/L) with high dose hepatitis B vaccination compared to standard dose hepatitis B vaccine at 4 weeks of completion of vaccination in patients with IBDTimepoint: At 4 weeks of completion of vaccination	—

Secondary

Measure	Time frame
1. To assess the effective immune response (antiHBs antibody titer 100 IU/L) with high dose hepatitis B vaccination compared to standard dose hepatitis B vaccine at 4 weeks of completion of vaccination in patients with IBDTimepoint: At 4 weeks of completion of vaccination;2. To assess the seroconversion (AIR and EIR) in patients with ulcerative colitis and Crohnâ??s disease.Timepoint: At 4 weeks of completion of vaccination;3. To assess the seroconversion (AIR and EIR) in active disease versus disease in remission.Timepoint: At 4 weeks of completion of vaccination	—

Measure

Time frame

1. To assess the effective immune response (antiHBs antibody titer 100 IU/L) with high dose hepatitis B vaccination compared to standard dose hepatitis B vaccine at 4 weeks of completion of vaccination in patients with IBDTimepoint: At 4 weeks of completion of vaccination;2. To assess the seroconversion (AIR and EIR) in patients with ulcerative colitis and Crohnâ??s disease.Timepoint: At 4 weeks of completion of vaccination;3. To assess the seroconversion (AIR and EIR) in active disease versus disease in remission.Timepoint: At 4 weeks of completion of vaccination

—

Countries

India

Contacts

Public ContactAnupam Kumar Singh

PGIMER

anupam.pgi@gmail.com8284822540

Outcome results

None listed

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