Rabiës pre exposure prophylaxis in patients with auto-immune diseases using immunosuppressive agents.

Title * Vaccinations in Immunocompromised Patients, Rabies Antibody Response after pre exposure prophylaxis - The VIPRAR study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25639

Enrollment

Registered

2020-12-02

Start date

2020-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auto-immune diseases (Inflammatory bowel disease/rheumatoid arthritis)

Interventions

We offer all eligible ICPs a three-dose rabies PrEP schedule on days 0, 7 and 21-28 intramuscularly, according to the current WHO guidelines for ICPs. At month 12, a 2-dose rabies PEP schedule will b

Eligibility

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • Diagnosis of one of the following o Primary immune deficiency disorder o Active malignancy o Anyone who received chemotherapy or anti-CD20 in the past 2 years. o Hemophilic disorder precluding intramuscular vaccination o (Functional) asplenia o Allergy to any of the components of the rabies vaccine. • Pregnant • Not able or willing to consent • Using other immunosuppressive agents than the mentioned

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
o Seroconversion 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. o SCR 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. o Persisting immunity at month 12, defined as the proportion of patients who had adequate antibody levels >0.5 IU/ml at month 12. o Factors associated with seroconversion on day 28, 60 and persisting immunity at month 12, such as age, gender, medication, comorbidities, smoking, alcohol and drug use.	—

Measure

Time frame

o Seroconversion 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. o SCR 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. o Persisting immunity at month 12, defined as the proportion of patients who had adequate antibody levels >0.5 IU/ml at month 12. o Factors associated with seroconversion on day 28, 60 and persisting immunity at month 12, such as age, gender, medication, comorbidities, smoking, alcohol and drug use.

—

Contacts

Public ContactHannah Garcia Garrido

Amsterdam UMC, University of Amsterdam

h.m.garciagarrido@amsterdamumc.nl0638054008

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)