Systemic Lupus ErythematosusPhase 4NCT02477150
Safety and Immunogenicity of a Zoster Vaccine in SLE
A Phase 4 study testing Zostavax in people with Systemic Lupus Erythematosus, run by Tuen Mun Hospital at 1 site in China.
Trial summary
To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Zostavax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SLE patients who fulfill ≥4 of the 1997 ACR (17) or the 2012 SLICC/ACR criteria for SLE (18)
- Age ≥18 years
- Clinically inactive disease with SELENA-SLEDAI score <6 (see below) and receiving stable dose of immunosuppressive agents for ≥6 months
- History of varicella (chickenpox) or herpes zoster infection in the past
- Willing to comply with all study procedures
Who cannot join
- Active infection, including upper respiratory tract infection
- Active untreated tuberculosis
- Human immunodeficiency virus (HIV) infection
- Lymphocyte count <500/mm2
- Reduced serum IgG, IgA or IgM level (below normal range)
- Serum creatinine >200umol/L
Show all 18Show fewer
- History of hematological malignancies (eg. lymphoma, leukaemia) and other solid tumors
- 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)
- Patients who are pregnant or plan to become pregnancy within one year of study entry
- Patients who cannot give a written consent (mentally incapable or illiterate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Zostavax, placebo
- Keywords
- lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZostavaxBiological
Vaccination of a zoster vaccine (Zostavax)
placeboBiological
placebo administration
| Study group | Role | What they receive |
|---|---|---|
| SLE (vaccine) | Active comparator | Zostavax SC injection (0.65ml) Receives: Biological: Zostavax |
| SLE (placebo) | Placebo comparator | Placebo SC injection (normal saline 0.65ml) Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody rise to varicella zoster virus
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
Measured: 6 weeks
Secondary outcomes (2)
safety (incidence of herpes zoster reactivation or chickenpox infection)
incidence of herpes zoster reactivation or chickenpox infection
Measured: week 6
T cell response to VZV
differences between IFN release upon VZV stimulation of PBMC
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
- Investigators
- CC Mok, MD, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477150
- Sponsor's protocol ID
- NTWC/CREC/15029
- Status last verified
- Sep 2019
- First submitted
- 17 Jun 2015
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mok CC, Chan KH, Ho LY, Fung YF, Fung WF, Woo PCY. Safety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial. Ann Rheum Dis. 2019 Dec;78(12):1663-1668. doi: 10.1136/annrheumdis-2019-215925. Epub 2019 Sep 17.
PubMed 31530556
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02477150
- Acronym / sponsor ID
- NTWC/CREC/15029
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the safety and immunogenicity of a herpes zoster vaccine in patients with SLE.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE (vaccine) | Active comparator | Biological: ZostavaxZostavax SC injection (0.65ml) |
| SLE (placebo) | Placebo comparator | Biological: placeboPlacebo SC injection (normal saline 0.65ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- SLE patients who fulfill ≥4 of the 1997 ACR (17) or the 2012 SLICC/ACR criteria for SLE (18)
- Age ≥18 years
- Clinically inactive disease with SELENA-SLEDAI score <6 (see below) and receiving stable dose of immunosuppressive agents for ≥6 months
- History of varicella (chickenpox) or herpes zoster infection in the past
- Willing to comply with all study procedures
Key exclusion criteria (18 listed)
- Active infection, including upper respiratory tract infection
- Active untreated tuberculosis
- Human immunodeficiency virus (HIV) infection
- Lymphocyte count <500/mm2
- Reduced serum IgG, IgA or IgM level (below normal range)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZostavaxVaccination of a zoster vaccine (Zostavax) | Biological | SLE (vaccine) |
| placeboplacebo administration | Biological | SLE (placebo) |
Primary outcome
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
2 secondary outcomes
safety (incidence of herpes zoster reactivation or chickenpox infection)
Time frame: week 6
T cell response to VZV
Time frame: week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Derived from this study: PubMed 31530556Mok CC, Chan KH, Ho LY, Fung YF, Fung WF, Woo PCY. Safety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial. Ann Rheum Dis. 2019 Dec;78(12):1663-1668. doi: 10.1136/annrheumdis-2019-215925. Epub 2019 Sep 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CC Mok, MD principal investigator
Tuen Mun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zostavax in people with Systemic Lupus Erythematosus, run by Tuen Mun Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibody rise to varicella zoster virus (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02477150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.