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Safety and Immunogenicity of a Zoster Vaccine in SLE

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ClinicalTrials.gov Identifier: NCT02477150
Recruitment Status : Active, not recruiting
First Posted : June 22, 2015
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital

Brief Summary:
To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Zostavax Biological: placebo Phase 4

Detailed Description:

Herpes zoster (HZ) (Shingles) is a painful condition caused by reactivation of varicella zoster virus (VZV) that remains dormant after primary infection. HZ reactivation may cause significant morbidity such as post-herpetic neuralgia and even mortality for disseminated infection, particularly in immunocompromised individuals.

HZ vaccine (Zostavax) is essentially a larger-than-normal dose of the chickenpox vaccine, which contains the Oka strain of live attenuated VZV. Zostavax has been shown to be safe and protective in immunocompetent elderly populations (>60 years of age) by reducing reactivation of HZ by 51% and post-herpetic neuralgia by 66%. Another study also demonstrated efficacy of Zostavax in reducing HZ infection by 70% in adults aged 50-59 years.

Data regarding the use of HZ vaccine in patients with rheumatic diseases are scant. A recent observational study involving 463,541 US patients with rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis and ankylosing spondylitis showed that 4% of patients had received HZ vaccination. After a median observation period of 2 years, the rate HZ reactivation among vaccinated patients was significantly lower than that of unvaccinated group (hazard ratio 0.61 [0.52-0.71]). Among 633 patients exposed to biologics at the time of vaccination, no cases of HZ or varicella infection occurred in the subsequent 42 days after vaccination. Thus, the vaccine appears to be safe in patients with autoimmune rheumatic diseases even receiving the biological agents.

HZ reactivation is fairly common in patients with systemic lupus erythematosus (SLE).

However, data regarding HZ vaccination in SLE patients are generally lacking. Safety and efficacy of HZ vaccination has recently been demonstrated in other immunocompromised groups such as HIV infection, post-chemotherapy and hematological malignancies. According to the 2011 EULAR recommendation, HZ vaccination may be considered in patients with autoimmune inflammatory rheumatic diseases provided that they are less seriously immunosuppressed.

The current study is designed to test for the immunogenicity and safety of a HZ vaccine (Zostavax) in patients with stable SLE who are receiving minimal immunosuppressive therapies for maintenance.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Shingles

Arm Intervention/treatment
Active Comparator: SLE (vaccine)
Zostavax SC injection (0.65ml)
Biological: Zostavax
Vaccination of a zoster vaccine (Zostavax)

Placebo Comparator: SLE (placebo)
Placebo SC injection (normal saline 0.65ml)
Biological: placebo
placebo administration




Primary Outcome Measures :
  1. antibody rise to varicella zoster virus [ Time Frame: 6 weeks ]
    Difference between the two groups in the proportion of patients who achieve a two-fold rise in IgG to VZV at week 6 post-vaccination compared to baseline


Secondary Outcome Measures :
  1. safety (incidence of herpes zoster reactivation or chickenpox infection) [ Time Frame: week 6 ]
    incidence of herpes zoster reactivation or chickenpox infection

  2. T cell response to VZV [ Time Frame: week 6 ]
    differences between IFN release upon VZV stimulation of PBMC



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477150


Locations
China
Department of Medicine, Tuen Mun Hospital
Hong Kong, China, 000
Sponsors and Collaborators
Tuen Mun Hospital
Investigators
Principal Investigator: CC Mok, MD Tuen Mun Hospital

Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT02477150     History of Changes
Other Study ID Numbers: NTWC/CREC/15029
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Keywords provided by Chi Chiu Mok, Tuen Mun Hospital:
lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs