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The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.
The spread of hepatitis A has prompted the need for vaccination against this virus. It is uncertain that IBD patients can achieve a truly protective response after vaccination. The efficacy and safety of hepatitis A vaccination have not been evaluated in this population of patients. We would like to estimate the efficacy and safety of vaccination against hepatitis A in patients with IBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients | Experimental | Patients diagnosed with IBD -> receive Epaxal Berna (virosomal hepatitis A vaccine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epaxal Berna (virosomal hepatitis A vaccine) | Biological | standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| antibody titer to hepatitis A vaccine | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| vaccine-associated adverse events and side effects | within the first 30 days after first vaccination | |
| vaccine-associated adverse events and side effects | within the first 30 days after second vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suk-Kyun Yang, M.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16553593 | Background | D'Acremont V, Herzog C, Genton B. Immunogenicity and safety of a virosomal hepatitis A vaccine (Epaxal) in the elderly. J Travel Med. 2006 Mar-Apr;13(2):78-83. doi: 10.1111/j.1708-8305.2006.00001.x. | |
| 20480515 | Background | Hou JK, Velayos F, Terrault N, Mahadevan U. Viral hepatitis and inflammatory bowel disease. Inflamm Bowel Dis. 2010 Jun;16(6):925-32. doi: 10.1002/ibd.21284. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C530970 | epaxal berna |
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|
| 24284413 | Derived | Park SH, Yang SK, Park SK, Kim JW, Yang DH, Jung KW, Kim KJ, Ye BD, Byeon JS, Myung SJ, Kim JH. Efficacy of hepatitis A vaccination and factors impacting on seroconversion in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2014 Jan;20(1):69-74. doi: 10.1097/01.MIB.0000437736.91712.a1. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |