Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above

NCT07892989 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SYS6052-001
• Study Type: interventional
• Target: 496
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• solicited adverse events

  within 14 days post each vaccination

• unsolicited adverse events

  within 30 days post each vaccination

• Phase I: abnormal laboratory test findings

  within 4 days post each vaccination

• anti-glycoprotein E (gE) antibody

  On Day 30 after the completion of the full vaccination course

• anti-VZV antibody

  On Day 30 after the completion of the full vaccination course

Secondary Outcomes (4)

• serious adverse events

  from the first vaccination through 12 months post the second vaccination

• adverse events of special interest

  from the first vaccination through 12 months post the second vaccination

• pregnancy events

  from the first vaccination through 12 months post the second vaccination

• anti-glycoprotein E (gE) antibody

  Month 6 and Month 12 after full vaccination

Study Arms (4)

Investigational vaccine low dose

EXPERIMENTAL

Biological: Recombinant Zoster Vaccine (CHO cell) SYS6052

Investigational vaccine high dose

EXPERIMENTAL

Biological: Recombinant Zoster Vaccine (CHO cell) SYS6052

Placebo

PLACEBO COMPARATOR

Biological: Placebo: 0.9% sodium chloride injection

Active Comparator Vaccine

ACTIVE COMPARATOR

Biological: Active Comparator Vaccine

Interventions

Recombinant Zoster Vaccine (CHO cell) SYS6052 BIOLOGICAL

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.

Investigational vaccine high dose; Investigational vaccine low dose

Placebo: 0.9% sodium chloride injection BIOLOGICAL

Placebo: 0.9% sodium chloride injection

Placebo

Active Comparator Vaccine BIOLOGICAL

Active Comparator Vaccine

Active Comparator Vaccine

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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；
• 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;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Herpes Zoster

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share