ZosterPhase 3NCT06001606
Immunogenicity, Reactogenicity of Shingrix in SLE
A Phase 3 study testing Shingrix in people with Zoster and Systemic Lupus Erythematosus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Zoster, Systemic Lupus Erythematosus, Vaccine Reaction
- What is being tested?
- Shingrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2023to 24 Apr 2025
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥ 19 years of age at time of consent
- ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)
- Clinically stable SLE
- Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
- Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
- Antimalarials (≤400 mg/day)
Show all 12Show fewer
- Azathioprine (≤3 mg/kg/day)
- Mycophenolate mofetil (≤3 mg/day)
- Tacrolimus (≤5mg/day)
- Methotrexate (≤20mg/week)
- Cyclosphosphamide (≤1mg/BSA/month)
- Must understand and voluntarily sign an informed consent form including writing consent for data protection
Who cannot join
- Pregnant or lactating females
- Acute infection with T >38°C at the time of vaccination
- Previous anaphylactic response to vaccine components or to egg
- History of Guillain-Barre syndrome or demyelinating syndromes
- Any condition including laboratory abnormality which places the subject at unacceptable risk
- Subjects who decline to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Eun Bong Lee, MD PhD, 82-2-2072-3944, leb7616@snu.ac.kr
Ju Yeon Kim, MD, 82-2-2072-2957, simple0693@gmail.com
About this study
Official title: Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
- Conditions
- Zoster, Systemic Lupus Erythematosus, Vaccine Reaction
- Being tested
- Shingrix, Placebo
- Medical subject headings
- Herpes Zoster, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShingrixDrug
Shingrix vaccination
PlaceboDrug
Placebo vaccination
| Study group | Role | What they receive |
|---|---|---|
| Shingrix | Experimental | Not described Receives: Drug: Shingrix |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of positive humoral vaccine response at 1 month post-dose 2
Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration
Measured: 3 months
Secondary outcomes (4)
Frequency of positive humoral vaccine response at 6 months post-dose 2
Measured: 8 months
Frequency of humoral responses 12 month post-dose 2
Measured: 14 month
Anti-gE antibody concentration at 6 months post-dose 2
Measured: 8 months
Anti-gE antibody concentration at 12 months post-dose 2
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start8 May 2023
- Primary completion24 Apr 2025 (estimated)
- Study completion24 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ZosterStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001606
- Sponsor's protocol ID
- H-2303-017-1410
- Status last verified
- Apr 2023
- First submitted
- 1 May 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JK, Lee YJ, Shin K, Kang EH, Ha YJ, Park JW, Kim MJ, Kim MH, Choi SR, Jung Y, Lee JH, In Jung J, Kim JY, Winthrop KL, Lee EB. A Multicenter, Prospective, Randomized, Parallel-Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Feb;75(2):171-177. doi: 10.1002/art.42318. Epub 2022 Dec 7.
PubMed 35930728Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.
PubMed 28468794Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.
PubMed 29572291Park JK, Kim M, Jung JI, Kim JY, Jeong H, Park JW, Winthrop KL, Lee EB. Immunogenicity, reactogenicity, and safety of two-dose adjuvanted herpes zoster subunit vaccine in patients with systemic lupus erythematosus in South Korea: a single-centre, randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. 2024 Jun;6(6):e352-e360. doi: 10.1016/S2665-9913(24)00084-5. Epub 2024 May 3.
PubMed 38710192
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06001606
- Acronym / sponsor ID
- H-2303-017-1410
- Conditions
- Zoster, Systemic Lupus Erythematosus, Vaccine Reaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 24 Apr 2025 (estimated)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 21 Aug 2023 (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.
To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shingrix | Experimental | Drug: Shingrix |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females ≥ 19 years of age at time of consent
- ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)
- Clinically stable SLE
- Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
- Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks
Key exclusion criteria (6 listed)
- Pregnant or lactating females
- Acute infection with T >38°C at the time of vaccination
- Previous anaphylactic response to vaccine components or to egg
- History of Guillain-Barre syndrome or demyelinating syndromes
- Any condition including laboratory abnormality which places the subject at unacceptable risk
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 |
|---|---|---|
| ShingrixShingrix vaccination | Drug | Shingrix |
| PlaceboPlacebo vaccination | Drug | Placebo |
Primary outcome
Frequency of positive humoral vaccine response at 1 month post-dose 2
Time frame: 3 months
Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration
4 secondary outcomes
Frequency of positive humoral vaccine response at 6 months post-dose 2
Time frame: 8 months
Frequency of humoral responses 12 month post-dose 2
Time frame: 14 month
Anti-gE antibody concentration at 6 months post-dose 2
Time frame: 8 months
Anti-gE antibody concentration at 12 months post-dose 2
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Results publication: PubMed 35930728Park JK, Lee YJ, Shin K, Kang EH, Ha YJ, Park JW, Kim MJ, Kim MH, Choi SR, Jung Y, Lee JH, In Jung J, Kim JY, Winthrop KL, Lee EB. A Multicenter, Prospective, Randomized, Parallel-Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Feb;75(2):171-177. doi: 10.1002/art.42318. Epub 2022 Dec 7.
- Results publication: PubMed 28468794Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.
- Results publication: PubMed 29572291Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.
- Derived from this study: PubMed 38710192Park JK, Kim M, Jung JI, Kim JY, Jeong H, Park JW, Winthrop KL, Lee EB. Immunogenicity, reactogenicity, and safety of two-dose adjuvanted herpes zoster subunit vaccine in patients with systemic lupus erythematosus in South Korea: a single-centre, randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. 2024 Jun;6(6):e352-e360. doi: 10.1016/S2665-9913(24)00084-5. Epub 2024 May 3.
- Individual participant dataSharing planned: No
Related trials for Zoster
Not yet recruitingPhase 1/2
Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above
Herpes Zoster
Not yet recruitingPhase 2
A Study Exploring the Effect of Adjuvanted RZV or RSVPreF3 Vaccines on Coronary Plaque Progression in Adults >=50 Years of Age at Risk for Cardiovascular Events
Cardiovascular Disease
Active, not recruitingPhase 3
Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and Older
Herpes Zoster
Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
Shingles, Herpes Zoster
Active, not recruitingPhase 3
A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)
Herpes Zoster
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shingrix in people with Zoster and Systemic Lupus Erythematosus, run by Seoul National University Hospital at 1 site in South Korea.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Kyun Park, MD (82-2-2072-4765, jinkyunpark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of positive humoral vaccine response at 1 month post-dose 2 (time frame: 3 months). 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 NCT06001606, which also lists 4 linked publications.
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 21 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.