efficacy of Double dose versus Single dose of Hepatitis B vaccination in patients with inflammatory bowel disease
Phase 3
- Conditions
- Health Condition 1: K508- Crohns disease of both small andlarge intestineHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2022/07/043713
- Lead Sponsor
- Anupam Kumar Singh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 <10 mIU/L
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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