Inflammatory Bowel Diseases Clinical Trial
Official title:
Intra-dermal With Topical Imiquimod Pretreatment Versus Intra-muscular Hepatitis B Vaccination in IBD Patients - a Double-blind Randomized Controlled Trial
Verified date | May 2022 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 the disease itself and secondary to the use of medications including immunosuppressants and biologics, predisposing them to various opportunistic infection including hepatitis. Vaccination against hepatitis B virus (HBV) is recommended to prevent CHB and its related complications including flare up of acute hepatitis, cirrhosis and hepatocellular carcinoma. However, it is reported that efficacy with conventional intramuscular hepatitis B vaccination in IBD patients is suboptimal, especially among those receiving biologic therapies. Various strategies in boosting vaccine immunogenicity including the utilization of higher vaccination dose, shorter dosing interval, or alternate route of vaccine administration have been studied.6 Intradermal route of vaccination has been recently shown to be an effective way in augmenting immune response in specific patient groups who are known poor responders, including elderly and immunocompromised patients. In addition, topical imiquimod, a synthetic agonist of toll-like receptor 7 (TLR7), has been shown to further boost up the immunogenicity response when applied to the site before intradermal vaccination. The proposed study is the first clinical trial comparing the efficacy of intradermal hepatitis B vaccination with adjuvant topical application of imiquimod cream with the conventional intramuscular hepatitis B vaccination in IBD patients.
Status | Completed |
Enrollment | 104 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Queen Mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sero-protection rate to HBV | Percentage of recruited subjects with anti-HBs titre = 10 IU/L | 12 months after first dose of vaccine | |
Secondary | Injection site adverse effect of intradermal hepatitis B vaccine in IBD patients | Injection site adverse effect recorded as following, with left and right arm recorded separately: Pain - 0 = no pain / 1 = pain on touch / 2 = pain during arm raising / 3 = pain on arm movement Presence or absence of the following Itching Swelling Hot sensation Bruise |
up to 7 days after each dose of vaccination | |
Secondary | Systemic adverse effect of intradermal hepatitis B vaccine in IBD patients | Presence of absence of systemic adverse effect recorded as following: Fever Malaise Headache Myalgia Arthralgia Nausea Diarrhoea |
up to 7 days after each dose of vaccination | |
Secondary | Sero-protection rate to HBV at 1 and 6 months after dose of vaccine | 1 and 6 month after first dose of vaccine | ||
Secondary | Percentage of good responder defined as anti-HBs = 100 IU/L | 12 month after first dose of vaccine | ||
Secondary | Geometric mean concentration of anti-HBs at 1, 6 and 12 months after first dose of vaccine | 1, 6 and 12 month after first dose of vaccine |
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