Herpes ZosterPhase 1NCT06954818
Safety and Immunogenicity of SYS6017 in Healthy Participants Aged 40 Years or More
A Phase 1 study testing A zoster mRNA vaccine SYS6017 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
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2025to 10 Nov 2026
- Phase
- Phase 1
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. Healthy participants aged 40 years or more;
- 2. Be able to understand the study procedures and comply with the requirements of the protocol for the scheduled visits, voluntarily consent to participate in the study and sign the informed consent form (ICF);
- 3. Being in good health at the discretion of investigators based on medical history inquiry, physical examination, laboratory test and electrocardiograph examination;
- 4. For female participants of childbearing potential: no sexual activity or used effective contraceptive methods within one menstrual cycle before enrollment; no pregnancy plans and agree to used effective contraceptive methods with 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. Have abnormal test or examination result that is of Grade 1 (inclusive) or more in accordance with the Guidelines for Adverse Event Grading Standards for Clinical Trials of Preventive Vaccines (2019) issued by China National Medical Products Administration or other applicable adverse event grading standards referred in the protocol;
- 5. History of allergy to any component of the investigational vaccine, or history of severe allergic reaction (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenia purpura or Arthus reaction) to vaccines or medicines;
- 6. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that would increase the risk of myocarditis or pericarditis;
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- 7. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.
- 8. Current epilepsy or convulsion, severe neurological or psychiatric disorders;
- 9. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or current treatment with anticoagulants, etc;
- 10. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;
- 11. 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;
- 12. Have diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy;
- 13. Have received immunosuppressants, immunostimulants, or other immunomodulatory medicines (e.g., corticosteroids, ≥ 20 mg/d prednisone or equivalent) for a long time (defined as 14 days or more), within 6 months before enrollment, or planning to receive the aforementioned medicines during the study; inhaled and topical steroids are allowed;
- 14. Have received whole blood, plasma, serum, immunoglobulins, or monoclonal antibodies within 3 months before enrollment, or planning to receive these products during the study;
- 15. Blood donation or blood loss ≥ 450 mL within 1 month before enrollment, or planning to donate blood during the study;
- 16. Have received any other vaccine within 30 days before enrollment, or planning to receive any other vaccine within 30 days after the last dose;
- 17. Currently participating in or planning to participate in other clinical trials during the study;
- 18. For female participant of childbearing potential: having positive urine pregnancy test, being in pregnancy or lactation before enrollment;
- 19. Unable to comply with the study procedures or adhere to the study requirements, or there are other conditions that make the participation in this study inappropriate, as determined 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, Observer-blind, Placebo-controlled, Adaptive Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of SYS6017(a Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years or More
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. This randomized, observer-blind, placebo-controlled, adaptive phase 1 trial aims to evaluate the safety and immunogenicity of an investigational zoster mRNA vaccine in healthy participants aged 40 years or more.
- Conditions
- Herpes Zoster
- Being tested
- A zoster mRNA vaccine SYS6017, Placebo
- 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 is an investigational lipid nanoparticle (LNP)-coated mRNA vaccine encoding the glycoprotein E (gE) of VZV, and indicated for active immunization for the prevention of zoster caused by the reactivation of latent VZV.
PlaceboOther
saline solution
| Study group | Role | What they receive |
|---|---|---|
| Investigational vaccine of Dosage A | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Investigational vaccine of Dosage B | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Investigational vaccine of Dosage C | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Investigational vaccine of Dosage D | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Investigational vaccine of Dosage E | Experimental | Not described Receives: Biological: A zoster mRNA vaccine SYS6017 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
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
Secondary outcomes (5)
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
Measured: from the first vaccination through 12 months post the second vaccination
anti-gE antibody geometric mean concentration, geometric mean fold increase and seroconversion rate.
Measured: before the second vaccination, 14 and 30 days post the second vaccination
anti-VZV antibody geometric mean titer, geometric mean fold increase and seroconversion rate.
Measured: before the second vaccination, 14 and 30 days post the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start10 May 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Nov 2026 (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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants are to be randomly assigned to the investigational vaccine or the placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT06954818
- Sponsor's protocol ID
- SYS6017-001
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No