Herpes ZosterPhase 2NCT07354659
Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above
A Phase 2 study testing A zoster mRNA vaccine SYS6017 and Active Comparator Vaccine in people with Herpes Zoster, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- A zoster mRNA vaccine SYS6017 and Active Comparator Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Individuals aged 40 years or older;
- 2. Able to understand the study procedures, comply with the protocol requirements to attend all the scheduled visits, voluntarily consent to participate in the study, and sign the informed consent form;
- 3. Is physically eligible at the discretion of investigators based on medical history inquiry and physical examination; For participants with chronic underlying diseases (e.g., diabetes mellitus, hypertension, hyperlipidemia and other chronic conditions), they may be enrolled if their conditions have been well controlled within 3 months prior to enrollment in this study (i.e., additional medical interventions or major adjustments to treatments are not required);
- 4. For female participants of childbearing potential: No sexual activity or effective contraceptive methods were used within one menstrual cycle before enrollment; No pregnancy plans and agree to adopt effective contraceptive methods within 8 months after enrollment.
Who cannot join
- 1. History of zoster;
- 2. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);
- 3. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;
- 4. History of allergy to any component of the investigational vaccine; or history of severe allergic reactions to vaccines or medications (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction);
- 5. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that could increases the risk of myocarditis or pericarditis
- 6. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.;
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- 7. Current epilepsy or convulsion, severe neurological or psychiatric disorders;
- 8. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or ongoing treatment with anticoagulants, etc.;
- 9. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;
- 10. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases, etc;
- 11. History of diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy before enrollment;
- 12. Long-term (defined as more than 14 consecutive days) systemic use of immunosuppressants, immunostimulants, or other immunomodulatory drugs (e.g., corticosteroids at a dose of ≥ 20 mg/day prednisone or equivalent) within 6 months prior to enrollment; however, inhaled and topical corticosteroids are permitted; or planned administration of the aforementioned agents during the study period;
- 13. Administration of whole blood, plasma, serum, immunoglobulin, or monoclonal antibodies within 3 months prior to enrollment, or planned administration of the aforementioned products during the study period;
- 14. Blood donation or blood loss ≥ 450 mL within one month before enrollment, or planning to donate blood during the study;
- 15. Vaccination with any other vaccines within 30 days prior to enrollment, or planned vaccination with any other vaccines within 30 days after the last dose of the study vaccine;
- 16. Current participation in or planned participation in other clinical trials during the study period;
- 17. For female participants of childbearing potential: positive pregnancy test result prior to enrollment, current pregnancy or lactation, or planned pregnancy within 8 months after enrollment;
- 18. Unable to comply with the study procedures and requirements, or presence of other conditions that make the participant inappropriate for this clinical trial, as judged by the investigators.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Study to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above
Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled "A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above".
- Conditions
- Herpes Zoster
- Being tested
- A zoster mRNA vaccine SYS6017, Placebo, Active Comparator Vaccine
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A zoster mRNA vaccine SYS6017Biological
SYS6017，two-dose vaccination schedule (Month 0, 2)
PlaceboOther
0.9% saline，two-dose vaccination schedule (Month 0, 2)
Active Comparator VaccineBiological
Recombinant Zoster Vaccine (CHO cell)，two-dose vaccination schedule (Month 0, 2)
| Study group | Role | What they receive |
|---|---|---|
| Dosage A of zoster mRNA vaccine SYS6017 | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Dosage B of zoster mRNA vaccine SYS6017 | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Dosage C of zoster mRNA vaccine SYS6017 | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Dosage D of zoster mRNA vaccine SYS6017 | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Dosage E of zoster mRNA vaccine SYS6017 | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Active Comparator Vaccine | Active comparator | Not described Receives: Biological: Active Comparator Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
solicited adverse events
Measured: within 14 days post each vaccination
unsolicited adverse events
Measured: within 30 days post each vaccination
Geometric Mean Concentration (GMC) of anti-gE antibody
Measured: On Day 14 and Day 30 after the completion of the full vaccination course
Geometric Mean Fold Increase (GMFI) of anti-gE antibody
Measured: On Day 14 and Day 30 after the completion of the full vaccination course
Seroconversion Rate (SCR) of anti-gE antibody
Measured: On Day 14 and Day 30 after the completion of the full vaccination course
Secondary outcomes (7)
serious adverse events
Measured: from the first vaccination through 12 months post the second vaccination
adverse events of special interest
Measured: from the first vaccination through 12 months post the second vaccination
pregnancy events reported by the participants
Measured: from the first vaccination through 12 months post the second vaccination
Geometric Mean Titer (GMT) of anti-VZV antibody
Measured: On Day 14 after the completion of the full vaccination course
Geometric Mean Fold Increase (GMFI) of anti-VZV antibody
Measured: On Day 14 after the completion of the full vaccination course
Seroconversion Rate (SCR) of anti-VZV antibody
Measured: On Day 14 after the completion of the full vaccination course
cellular immune response
the frequency of peripheral blood mononuclear cell (PBMC) secreting gE-specific cytokines
Measured: On Day 14 and Day 30 after the completion of the full vaccination course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion10 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo or active-controlled, Masking
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354659
- Sponsor's protocol ID
- SYS6017-002
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Study to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above
- ClinicalTrials.gov ID
- NCT07354659
- Acronym / sponsor ID
- SYS6017-002
- Conditions
- Herpes Zoster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Jan 2026 (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.
Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled "A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- Randomized, placebo or active-controlled, Masking
| Arm | Type | Receives |
|---|---|---|
| Dosage A of zoster mRNA vaccine SYS6017 | Experimental | Biological: A zoster mRNA vaccine SYS6017 |
| Dosage B of zoster mRNA vaccine SYS6017 | Experimental | Biological: A zoster mRNA vaccine SYS6017 |
| Dosage C of zoster mRNA vaccine SYS6017 | Experimental | Biological: A zoster mRNA vaccine SYS6017 |
| Dosage D of zoster mRNA vaccine SYS6017 | Experimental | Biological: A zoster mRNA vaccine SYS6017 |
| Dosage E of zoster mRNA vaccine SYS6017 | Experimental | Biological: A zoster mRNA vaccine SYS6017 |
| Placebo | Placebo comparator | Other: Placebo |
| Active Comparator Vaccine | Active comparator | Biological: Active Comparator Vaccine |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Individuals aged 40 years or older;
- 2. Able to understand the study procedures, comply with the protocol requirements to attend all the scheduled visits, voluntarily consent to participate in the study, and sign the informed consent form;
- 3. Is physically eligible at the discretion of investigators based on medical history inquiry and physical examination; For participants with chronic underlying diseases (e.g., diabetes mellitus, hypertension, hyperlipidemia and other chronic conditions), they may be enrolled if their conditions have been well controlled within 3 months prior to enrollment in this study (i.e., additional medical interventions or major adjustments to treatments are not required);
- 4. For female participants of childbearing potential: No sexual activity or effective contraceptive methods were used within one menstrual cycle before enrollment; No pregnancy plans and agree to adopt effective contraceptive methods within 8 months after enrollment.
Key exclusion criteria (18 listed)
- 1. History of zoster;
- 2. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);
- 3. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;
- 4. History of allergy to any component of the investigational vaccine; or history of severe allergic reactions to vaccines or medications (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction);
- 5. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that could increases the risk of myocarditis or pericarditis
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 |
|---|---|---|
| A zoster mRNA vaccine SYS6017SYS6017，two-dose vaccination schedule (Month 0, 2) | Biological | Dosage A of zoster mRNA vaccine SYS6017, Dosage B of zoster mRNA vaccine SYS6017, Dosage C of zoster mRNA vaccine SYS6017, Dosage D of zoster mRNA vaccine SYS6017, Dosage E of zoster mRNA vaccine SYS6017 |
| Placebo0.9% saline，two-dose vaccination schedule (Month 0, 2) | Other | Placebo |
| Active Comparator VaccineRecombinant Zoster Vaccine (CHO cell)，two-dose vaccination schedule (Month 0, 2) | Biological | Active Comparator Vaccine |
Primary outcome
solicited adverse events
Time frame: within 14 days post each vaccination
unsolicited adverse events
Time frame: within 30 days post each vaccination
Geometric Mean Concentration (GMC) of anti-gE antibody
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
Geometric Mean Fold Increase (GMFI) of anti-gE antibody
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
Seroconversion Rate (SCR) of anti-gE antibody
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
7 secondary outcomes
serious adverse events
Time frame: from the first vaccination through 12 months post the second vaccination
adverse events of special interest
Time frame: from the first vaccination through 12 months post the second vaccination
pregnancy events reported by the participants
Time frame: from the first vaccination through 12 months post the second vaccination
Geometric Mean Titer (GMT) of anti-VZV antibody
Time frame: On Day 14 after the completion of the full vaccination course
Geometric Mean Fold Increase (GMFI) of anti-VZV antibody
Time frame: On Day 14 after the completion of the full vaccination course
Seroconversion Rate (SCR) of anti-VZV antibody
Time frame: On Day 14 after the completion of the full vaccination course
cellular immune response
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A zoster mRNA vaccine SYS6017 and Active Comparator Vaccine in people with Herpes Zoster, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
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 4 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: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
solicited adverse events (time frame: within 14 days post each vaccination). The study lists 5 primary outcomes in all. 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 21 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.