Safety and Immunogenicity of a Zoster Vaccine in SLE

September 2, 2019 updated by: Chi Chiu Mok, Tuen Mun Hospital

Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China, 000
        • Department of Medicine, Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety (incidence of herpes zoster reactivation or chickenpox infection)
Time Frame: week 6
incidence of herpes zoster reactivation or chickenpox infection
week 6
T cell response to VZV
Time Frame: week 6
differences between IFN release upon VZV stimulation of PBMC
week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Investigators

  • Principal Investigator: CC Mok, MD, Tuen Mun Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 2, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTWC/CREC/15029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on Zostavax

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe