Status:
COMPLETED
Intra-dermal With Topical Imiquimod Pretreatment Versus Intra-muscular Hepatitis B Vaccination in IBD Patients
Lead Sponsor:
The University of Hong Kong
Conditions:
Inflammatory Bowel Diseases
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Inflammatory bowel disease (IBD) has witnessed a rising incidence globally and in Hong Kong, an area where chronic hepatitis B (CHB) remains endemic. IBD patients are usually immunocompromised due to ...
Detailed Description
Aim of study To compare the efficacy of intradermal hepatitis B vaccination with adjuvant topical imiquimod with conventional intramuscular hepatitis B vaccination in IBD patients. Methodology Patien...
Eligibility Criteria
Inclusion
- Adults aged over 18 years old
- Confirmed IBD diagnosis (Ulcerative colitis, Crohns disease or IBD-Unclassified)
- HBsAg -ve / anti-HBs / antiHBc -ve
- Subjects must give written informed consent
- Subjects must be available to complete the study and comply with study procedures
Exclusion
- Inability or unwilling to follow all required study procedures
- History of allergy or severe adverse reaction to the study vaccines, their components, topical imiquimod or aqueous cream
- Pregnant or lactating women
- HBsAg / anti-HBs / anti-HBc +ve
- Confirmed hepatitis C virus (HCV) (anti-HCV +ve) infection
- Fever (axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination, subjects can be recruited after the febrile episode subsides
- Have an active neoplastic disease
- Have any condition which the investigator believes may prevent successful completion of the study or interfere with results of the study
- Received an experimental agent (vaccine, drug, biologic, medication) within 1 month prior to vaccination or expect to receive an experimental agent during the study period
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04083157
Start Date
August 12 2019
End Date
December 30 2021
Last Update
May 18 2022
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, China