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Table 1 Checklist regarding clinical and immunological requirements prior to varicella zoster virus vaccination

From: Varicella-zoster-virus vaccination in immunosuppressed children with rheumatic diseases using a pre-vaccination check list

Step 1: Rating of immunosuppressive therapy Step 2: Prerequisites Step 3: Testing protocol Step 4: Decision about vaccination
Low-intensity immunosuppression (LIIS)
 □ Prednisone ≤ 0,5mg/kg (max. 10mg) daily
 □ Methotrexate ≤ 15mg/m2 (max. 15mg) weekly
 □ Azathioprine ≤ 2mg/kg (max. 100mg) daily
High-intensity immunosuppression (HIIS)
Glucocorticoids and synthetic DMARDs
 □ Prednisone > 0,5 to < 2mg/kg (> 10mg to < 20mg) daily
 □ Methotrexate > 15mg/m2 or > 15mg to 30mg weekly
 □ Azathioprine > 2 to 3mg/kg daily
 □ Leflunomide ≤ 0,5mg/kg (max. 20mg) daily
 □ Cyclosporine ≤ 3mg/kg daily (trough level ≤ 100μg/l)
 □ mTOR-inhibitors (sirolimus or everolimus) (trough level ≤ 4 μg/l)
 □ Mycophenolate ≤ 1200mg/m2 (max. 2g) daily
Biological DMARDs
 □ Abatacept ≤ 10mg/kg per 4 weeks
 □ Adalimumab ≤ 24mg/m2 (max. 40mg) per 2 weeks
 □ Anakinra ≤ 3mg/kg (max. 150mg) daily
 □ Etanercept ≤ 0,8mg/kg (max. 50mg) weekly
 □ Infliximab ≤ 6mg/kg per 4 weeks
 □ Tocilizumab ≤ 12mg/kg biweekly if weight < 30kg
 □ Tocilizumab ≤ 8mg/kg biweekly if weight > 30kg
Special situations:
 • If on canakinumab, consider switching to anakinra temporarily.
I. Medical history and physical exam
 □ No family history or clinical evidence of primary immunodeficiency
 □ No measles-mumps-rubella vaccination at the same time or within < 4 weeks before VV
 □ For 2nd VV: At least 3 months from first dose of VV for patients on HIIS
II. Clinical assessment
 □ Inactive rheumatic disease
 □ Stable antirheumatic therapy for at least 3 months
 □ No active infection
III. Medications
 □ Not more than 2 synthetic DMARDs
 □ Not more than 1 biological agent +/− 1 synthetic DMARD
 □ No IV methylprednisolone pulse therapy or oral prednisone ≥ 2mg/kg or ≥ 20mg daily for > 2 weeks within < 1 month before and after VV
 □ No IV cyclophosphamide in previous 6 months
 □ No rituximab in previous 6 months or lasting B-cell deficiency
 □ No IVIG in previous 6 months (high-dose IVIG [2g/kg] 11 months)
 □ No blood products in previous 3 months
 □ No therapy with aspirin planned in 6 weeks after vaccination
Basic laboratory testing for all patients:
 □ VZV-IgG < 200 mIU/ml (prior to1st VV)
 □ WBC ≥ 3,000/mm3
 □ Lymphocytes ≥ 1,200/mm3
 □ IgG ≥ 500 mg/dl
 □ IgM ≥ 20mg/dl
 □ Tetanus toxoid antibody ≥ 0.1 IU/ml
Additional laboratory testing for patients on HIIS or LIIS with abnormal basic lab result:
 □ CD4 cell count > 200/mm3 if > 5 yrs old OR CD4 cell count > 500/mm3 if 1-5 yrs old
 □ T cell function testinga positive
Special situations:
• If WBC < 3000/mm3:
 • exclude neutropenia <1500/mm3
• If lymphocytes 700-1.200/mm3:
 • rule out low CD4+ T-cells
• If Lymphocytes < 700/mm3:
 • absolute contraindication
• If IgG < 500mg/dl or IgM < 20mg/dl:
 • rule out humoral and cellular immunodeficiency
• If tetanus antibody-level < 0,10IU/ml:
 • give tetanus vaccination and control serologic response in 4 weeks
 □ All prerequisites are met
 □ Basic laboratory testing normal
 □ Additional lab testing normal (if applicable), or additional testing not applicable
IF ALL THREE ITEMS ABOVE ARE CHECKED, VV IS SUPPORTED WITHOUT SUSPENSION OF THE CURRENT IMMUNOSUPPRESSION.b,c
  1. Abbreviations: DMARD disease-modifying antirheumatic drugs, HIIS high-intensity immunosuppression, LIIS low-intensity immunosuppression, VV varicella vaccination, VZV-IgG anti varicella zoster virus titre, WBC white blood cell count.
  2. avia Tuberculosis Interferon-gamma-release assays (for example, TB-EliSpot® or Quantiferon® test) demonstrating a positive (control) mitogen response OR other positive dedicated T cell function testing.
  3. bPatientsfullfilling these pre-vaccination criteria, also meet the immunological precautions requested by the manufacturer of Varilrix (Glaxo-Smith-Kline) for the in-label application.
  4. cEspecially in case of breakthrough or vaccine-induced VZV disease with >50 skin lesions or a rash lasting >7 days: strongly consider treatment with acyclovir and contact pediatric rheumatologist for a possible reduction of immunosuppressive therapy