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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02477150 |
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Date of registration:
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17/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Immunogenicity of a Zoster Vaccine in SLE
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Scientific title:
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Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02477150 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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CC Mok, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tuen Mun Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. SLE patients who fulfill =4 of the 1997 ACR (17) or the 2012 SLICC/ACR criteria for
SLE (18)
2. Age =18 years
3. Clinically inactive disease with SELENA-SLEDAI score <6 (see below) and receiving
stable dose of immunosuppressive agents for =6 months
4. History of varicella (chickenpox) or herpes zoster infection in the past
5. Willing to comply with all study procedures
Exclusion Criteria:
1. Active infection, including upper respiratory tract infection
2. Active untreated tuberculosis
3. Human immunodeficiency virus (HIV) infection
4. Lymphocyte count <500/mm2
5. Reduced serum IgG, IgA or IgM level (below normal range)
6. Serum creatinine >200umol/L
7. History of hematological malignancies (eg. lymphoma, leukaemia) and other solid tumors
8. Patients receiving doses of immunosuppressive agents exceeding the following:
- Prednisolone (>15mg) or equivalent
- Azathioprine (>100mg/day)
- Mycophenolate mofetil (>1000mg/day)
- Cyclosporin A (>100mg/day)
- Tacrolimus (>3mg/day)
- Methotrextate (>15mg/week)
- Cyclophosphamide (any dose)
- Biological agents eg. rituximab, belimumab (any dose)
9. Patients who are pregnant or plan to become pregnancy within one year of study entry
10. Patients who cannot give a written consent (mentally incapable or illiterate)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Biological: Zostavax
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Biological: placebo
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Primary Outcome(s)
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antibody rise to varicella zoster virus
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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safety (incidence of herpes zoster reactivation or chickenpox infection)
[Time Frame: week 6]
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T cell response to VZV
[Time Frame: week 6]
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Secondary ID(s)
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NTWC/CREC/15029
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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