Herpes ZosterPhase 4NCT04748939
Shingrix in Patients With Rheumatic Diseases: a Double-blind Placebo-controlled RCT
A Phase 4 study testing recombinant subunit herpes zoster vaccine in people with Herpes Zoster, run by Tuen Mun Hospital at 1 site in China.
Trial summary
A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- recombinant subunit herpes zoster vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2026to 29 Sep 2026
- 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
- Patients with a diagnosis of rheumatic or immune-mediated diseases eg. SLE, RA, PSA, SpA, inflammatory myopathies, ANCA-related and large vessel vasculitides
- Age ≥18 years
- Stable or reducing doses of any the following immunosuppressive regimens within 4 weeks of study entry:
- Prednisolone ≥20mg/kg/day ± mycophenolate mofetil, azathioprine or the calcineurin inhibitors
- Cyclophosphamide (intravenous pulses or daily oral)
- B-cell depleting biological agents and their biosimilars eg. belimumab, anti-CD20 agents (next scheduled dose should be arranged to at least 12 weeks after study entry for rituximab or obinutuzumab)
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- Anti-TNFα biological agents and their biosimilars eg. infliximab, etanercept, adalimumab, golimumab, certolizumab
- Anti-interleukin-6 biological agents eg. tocilizumab, sarilumab
- Other biological agents eg. abatacept, ustekinumab, secukinumab, ixekizumab
- The JAK inhibitors eg. tofacitinib, baricitinib, upadacitinib
- Female patients with reproductive potential are allowed to participate in this study provided that they are willing to practice contraception for until at least 12 months after vaccination
- Willing to comply with all study procedures
Who cannot join
- Active infection, including upper respiratory tract infection
- Active HZ infection
- Active untreated tuberculosis
- HIV infection
- History of HZ or varicella vaccination in the past
- History of allergy to any vaccines
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- Patients who are pregnant or plan to become pregnancy within one year of study entry
- Lactating women
- 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: Safety and Immunogenicity of a Recombinant Subunit Herpes Zoster Vaccine in Patients With Rheumatic Diseases Undergoing Immunosuppressive or Biologic/Targeted DMARD Therapies: a Double-blind Randomized Placebo-controlled Trial
A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies
Read the detailed description
A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies.
Duration of study: 60 weeks
- Conditions
- Herpes Zoster
- Being tested
- recombinant subunit herpes zoster vaccine
- Keywords
- vaccine, rheumatic diseases, immunosuppressive, immunogenicity, biologics, targeted DMARDs
- Medical subject headings
- Herpes Zoster, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant subunit herpes zoster vaccineBiological
Also called Shingrix
vaccine administration
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Active comparator | Shingrix vaccine Receives: Biological: recombinant subunit herpes zoster vaccine |
| placebo | Placebo comparator | normal saline injection (0.5mL) Receives: Biological: recombinant subunit herpes zoster vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
humoral immune response to Shingrix
proportion of patients with 4x fold increase in anti-gE antibody titer
Measured: week 12 (compared with baseline)
Secondary outcomes (6)
Humoral immune response
proportion of patients with 4x fold increase in anti-gE antibody titer
Measured: week 52
adverse events
solicited
Measured: 7 days after injection
adverse events
unsolicited
Measured: 4 weeks after injection
flares of underlying diseases
disease flares
Measured: week 26 and 60
herpes zoster infection
herpes zoster infection
Measured: week 60
cell mediated response to vaccine
in 40 patients (20 from each arm); number of IFNγ-secreting CD4+ T cell colonies on ELISPOT assay
Measured: week 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start29 Sep 2026
- Primary completion29 Sep 2026
- Study completion29 Sep 2026
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies 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
- Model description
- double-blind randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- Chi Chiu Mok, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748939
- Sponsor's protocol ID
- NTWCShingrixstudy
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Recombinant Subunit Herpes Zoster Vaccine in Patients With Rheumatic Diseases Undergoing Immunosuppressive or Biologic/Targeted DMARD Therapies: a Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04748939
- Acronym / sponsor ID
- NTWCShingrixstudy
- Conditions
- Herpes Zoster
- Keywords
- vaccine, rheumatic diseases, immunosuppressive, immunogenicity, biologics, targeted DMARDs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 29 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 10 Feb 2021 (actual)
- 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.
A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies
Detailed description
A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases undergoing immunosuppressive or biologic/targeted DMARD therapies.
Duration of study: 60 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| vaccine | Active comparator | Biological: recombinant subunit herpes zoster vaccineShingrix vaccine |
| placebo | Placebo comparator | Biological: recombinant subunit herpes zoster vaccinenormal saline injection (0.5mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with a diagnosis of rheumatic or immune-mediated diseases eg. SLE, RA, PSA, SpA, inflammatory myopathies, ANCA-related and large vessel vasculitides
- Age ≥18 years
- Stable or reducing doses of any the following immunosuppressive regimens within 4 weeks of study entry:
- Female patients with reproductive potential are allowed to participate in this study provided that they are willing to practice contraception for until at least 12 months after vaccination
- Willing to comply with all study procedures
Key exclusion criteria (9 listed)
- Active infection, including upper respiratory tract infection
- Active HZ infection
- Active untreated tuberculosis
- HIV infection
- History of HZ or varicella vaccination in the past
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 |
|---|---|---|
| recombinant subunit herpes zoster vaccineAlso: Shingrixvaccine administration | Biological | placebo, vaccine |
Primary outcome
humoral immune response to Shingrix
Time frame: week 12 (compared with baseline)
proportion of patients with 4x fold increase in anti-gE antibody titer
6 secondary outcomes
Humoral immune response
Time frame: week 52
adverse events
Time frame: 7 days after injection
adverse events
Time frame: 4 weeks after injection
flares of underlying diseases
Time frame: week 26 and 60
herpes zoster infection
Time frame: week 60
cell mediated response to vaccine
Time frame: week 12 from baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Chi Chiu Mok 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 recombinant subunit herpes zoster vaccine in people with Herpes Zoster, 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 12 inclusion and 9 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: withdrawn, as of the sponsor's last update on 1 Oct 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
humoral immune response to Shingrix (time frame: week 12 (compared with baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.