Rabiës pre exposure prophylaxis in patients with auto-immune diseases using immunosuppressive agents.
- Conditions
- Auto-immune diseases (Inflammatory bowel disease/rheumatoid arthritis)
- Registration Number
- NL-OMON25639
- Lead Sponsor
- The International Society of Travel Medicine (ISTM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
•Adults aged 18-70 years old with a chronic inflammatory condition requiring treatment with one of the following drugs: adalimumab, infliximab, etanercept, golimumab, certolizumab, methotrexate, azathioprine, 6-mercaptopurine, thioguanine, steroids, tacrolimus or mycophenolic acid.
•Being naïve to rabies vaccines
•Anticipated travel to a rabies-endemic country in the future
•Diagnosis of one of the following
oPrimary immune deficiency disorder
oActive malignancy
oAnyone who received chemotherapy or anti-CD20 in the past 2 years.
oHemophilic disorder precluding intramuscular vaccination
o(Functional) asplenia
oAllergy to any of the components of the rabies vaccine.
•Pregnant
•Not able or willing to consent
•Using other immunosuppressive agents than the mentioned
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Boostability, defined as the proportion of patients who received a 3-dose PrEP schedule (0,7,28) and had adequate antibody levels >0.5 IU/L at day 7 after the 2-dose PEP schedule (0,3) given 1 year after the PrEP schedule.
- Secondary Outcome Measures
Name Time Method oSeroconversion rate (SCR) on day 28 (after 2 out of 3 doses PrEP), defined as the proportion of patients who developed adequate antibody levels >0.5 IU/ml on day 28.<br>oSCR on day 60 (after 3 out of 3 doses PrEP), defined as the proportion of patients who developed adequate antibody levels >0.5 IU/ml on day 60.<br>oPersisting immunity at month 12, defined as the proportion of patients who had adequate antibody levels >0.5 IU/ml at month 12.<br>oFactors associated with seroconversion on day 28, 60 and persisting immunity at month 12, such as age, gender, medication, comorbidities, smoking, alcohol and drug use.<br>