Herpes ZosterPhase 1/2NCT07892989
Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above
A Phase 1/2 study testing Recombinant Zoster Vaccine (CHO cell) SYS6052 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?
- Recombinant Zoster Vaccine (CHO cell) SYS6052 and Active Comparator Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 30 Jun 2028
- Phase
- Phase 1/2
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
- Aged 40 years and above, male or female;
- Able to understand the study procedures, comply with the protocol requirements to attend all planned follow-up visits, voluntarily agree to participate in the study, and sign the Informed Consent Form;
- Body mass index (BMI) meeting the requirement: 18.5 ≤ BMI < 32.5 kg/m²；
- Females of childbearing potential: no sexual intercourse within one menstrual cycle prior to enrollment, or use of effective contraceptive measures; no pregnancy plan within 8 months after enrollment and agreement to use effective contraceptive measures;
Who cannot join
- History of herpes zoster;
- History of prior vaccination with varicella or herpes zoster vaccines (including investigational vaccines);
- Close contact with a patient with varicella or herpes zoster within 1 year prior to enrollment;
- Axillary temperature ≥37.1℃ on the day of enrollment or within 24 hours prior to enrollment;
- Phase I: blood pressure measured on the day of enrollment: systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg; Phase II: blood pressure measured on the day of enrollment: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg；
- Abnormal results with clinical significance in laboratory tests (Phase I) or physical examination prior to enrollment；
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- History of allergy to any component of the investigational vaccine; or a history of severe allergic reactions to vaccines or drugs (including but not limited to anaphylaxis, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, or local allergic necrosis [Arthus reaction]);
- History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, neuromyelitis optica, and acute disseminated encephalomyelitis;
- Current epilepsy or seizures, severe neurological diseases, or psychiatric disorders;
- Contraindications to intramuscular injection, such as local infection or skin lesions at the injection site, severe thrombocytopenia, any coagulation disorder, or ongoing treatment with anticoagulants;
- Known malignancy, malignancy not adequately treated, or malignancy with potential risk of recurrence during the study period;
- Phase I: presence of chronic underlying diseases, including cardiovascular and cerebrovascular diseases, thrombotic diseases, hematologic and lymphatic diseases, hepatic and renal diseases, respiratory diseases, endocrine and metabolic diseases, musculoskeletal diseases, and autoimmune diseases; Phase II: presence of chronic underlying diseases (as described above) with unstable disease control within 3 months prior to enrollment; unstable disease control refers to the need for additional medical interventions or major adjustments to the treatment regimen;
- Immune insufficiency or deficiency diagnosed by a hospital prior to enrollment (including HIV infection); congenital or functional asplenia, or splenectomy;
- Long-term (defined as more than 14 days) systemic use of immunosuppressants, immunostimulants, or other immunomodulatory drugs within 6 months prior to enrollment (e.g., corticosteroids, ≥20 mg/day prednisone or equivalent; however, inhaled and topical steroids are permitted); or planned use of the above agents during the study period;
- Receipt of whole blood, plasma, serum, immunoglobulin, or monoclonal antibodies within 3 months prior to enrollment, or planned receipt of the above products during the study period;
- Blood donation or blood loss of ≥450 mL within 1 month prior to enrollment, or planned blood donation during the study period;
- Vaccination with any other vaccine within 30 days prior to enrollment, or planned vaccination with any other vaccine within 90 days after enrollment;
- Current participation, or planned participation during the study period, in other clinical trials;
- Females of childbearing potential: positive pregnancy test, pregnancy, or lactation prior to enrollment;
- In the investigator's judgment, inability to comply with study procedures or appointments; or any other condition unsuitable for participation in this clinical trial.
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, Controlled, Phase 1/2 Clinical Trial to Evaluate the Safety and Immunogenicity of SYS6052 (Recombinant Herpes Zoster Vaccine (CHO Cell)) Administered to 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, Controlled, Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of SYS6052 (Recombinant Herpes Zoster Vaccine (CHO Cell)) Administered to Participants Aged 40 Years and Above".
- Conditions
- Herpes Zoster
- Being tested
- Recombinant Zoster Vaccine (CHO cell) SYS6052, Placebo: 0.9% sodium chloride injection, 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.
Recombinant Zoster Vaccine (CHO cell) SYS6052Biological
SYS6052 is a recombinant herpes zoster vaccine (CHO cell) developed by CSPC Megalith Biopharmaceutical Co., Ltd . Its active ingredient is the VZV glycoprotein E (gE) recombinantly expressed in CHO cells, and it is intended for clinical use in the prevention of herpes zoster.
Placebo: 0.9% sodium chloride injectionBiological
Placebo: 0.9% sodium chloride injection
Active Comparator VaccineBiological
Active Comparator Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Investigational vaccine low dose | Experimental | Not described Receives: Biological: Recombinant Zoster Vaccine (CHO cell) SYS6052 |
| Investigational vaccine high dose | Experimental | Not described Receives: Biological: Recombinant Zoster Vaccine (CHO cell) SYS6052 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo: 0.9% sodium chloride injection |
| 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
Phase I: abnormal laboratory test findings
Measured: within 4 days post each vaccination
anti-glycoprotein E (gE) antibody
Measured: On Day 30 after the completion of the full vaccination course
anti-VZV antibody
Measured: On Day 30 after the completion of the full vaccination course
Secondary outcomes (4)
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-glycoprotein E (gE) antibody
Measured: Month 6 and Month 12 after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Jun 2028 (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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 496 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
- NCT07892989
- Sponsor's protocol ID
- SYS6052-001
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No