Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older

NCT06851832 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: VZV-ZHSW-01
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older.

Conditions

Herpes Zoster; Herpes Zoster Vaccine

Outcome Measures

Primary Outcomes (6)

• The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose.

  Within 14 days after each vaccine dose.

• The incidence of unsolicited adverse events (AEs) within 0-30 days after each vaccine dose.

  Within 30 days after each vaccine dose.

• The incidence of laboratory abnormalities (including blood biochemistry, blood routine, urine routine and electrocardiogram) on Day 3 after each vaccine dose.

  On Day 3 after each vaccine dose.（Applicable to Phase I only）

• The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) from the vaccination of the first dose to 12 months after full immunization.

  From the vaccination of the first dose to 12 months after full immunization.

• The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) one month after full immunization.

  Detected using intracellular cytokine staining (ICS) by flow cytometry

  One month after full immunization.（Applicable to Phase Ⅱ only）

• The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies one month after full immunization.

  Detected using enzyme-linked immunosorbent assay (ELISA).

  One month after full immunization.（Applicable to Phase Ⅱ only）

Secondary Outcomes (2)

• The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies at 6, 12, 24, and 36 months after full immunization.

  At 6, 12, 24, and 36 months after full immunization.（Applicable to Phase Ⅱ only）

• The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) before the second dose and at 6, 12, 24, and 36 months after full immunization.

  Before the second dose and at 6, 12, 24, and 36 months after full immunization（Applicable to Phase Ⅱ only）

Study Arms (6)

Recombinant zoster Vaccine (CHO cell) (low adjuvant)

EXPERIMENTAL

It is used for vaccination of experimental vaccine group A subjects in phase I and II clinical trials

Biological: Recombinant zoster vaccine(CHO cell)(low adjuvant)

Recombinant zoster Vaccine (CHO cell)

EXPERIMENTAL

It is used for vaccination of experimental vaccine group B subjects of phase I clinical trial , experimental vaccine group B1 and B2 subjects of phase II clinical trial

Zoster Vaccine, Live

ACTIVE COMPARATOR

It is used for vaccination of positive control group A1 and A2 subjects in phase Ⅱ clinical trial

Biological: Zoster Vaccine, Live

Recombinant Zoster Vaccine (CHO cell)

ACTIVE COMPARATOR

It is used for vaccination of positive control group B subjects in phase Ⅱ clinical trial

Recombinant Zoster Vaccine (CHO cell) (Adjuvant control)

PLACEBO COMPARATOR

It is used for vaccination of adjuvant control group subjects in phase Ⅰ clinical trial

Biological: Recombinant Zoster Vaccine (CHO cell) (Adjuvant control)

normal saline

PLACEBO COMPARATOR

Used in phase Ⅰ clinical trial; To maintain blinding, positive control group A1 and positive control group A2 received placebo on day 0 (for phase II clinical trial).

Biological: Normal Saline

Interventions

Recombinant zoster vaccine(CHO cell)(low adjuvant) BIOLOGICAL

The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 50 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose.

Recombinant zoster Vaccine (CHO cell) (low adjuvant)

Recombinant Zoster Vaccine (CHO cell) BIOLOGICAL

The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. Vaccination Schedule 1: A total of two doses will be given, with the second dose administered 30 days after the first dose. Vaccination Schedule 2: A total of two doses will be given, with the second dose administered 60 days after the first dose \[only applicable to the Phase II Experimental Vaccine Group B2\].

Zoster Vaccine, Live BIOLOGICAL

The dosage for each administration is 0.5 mL, containing not less than 4.3 lg PFU of varicella-zoster live virus, administered subcutaneously at the attachment site of the lower edge of the deltoid muscle on the outer side of the upper arm. A total of one dose will be given. To maintain blinding, the positive control group A1 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 30. The positive control group A2 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 60.

Zoster Vaccine, Live

Normal Saline BIOLOGICAL

The dosage for each administration is 0.5 mL, containing 0.5 mL of NaCl solution, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose (applicable to Phase I clinical trial). To maintain blinding, subjects in the positive control A1 and positive control A2 groups will receive a placebo on Day 0 (applicable to Phase II clinical trial).

normal saline

Recombinant Zoster Vaccine (CHO cell) (Adjuvant control) BIOLOGICAL

The dosage for each administration is 0.5 mL, containing 0.25 mL of MF59 and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose.

Recombinant Zoster Vaccine (CHO cell) (Adjuvant control)

Eligibility Criteria

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

You may qualify if:

• Male or female participants aged 40 years or older at the time of enrollment.
• Voluntarily agrees to participate in the trial, fully understands, and signs the informed consent form.
• Able to attend all scheduled follow-ups and comply with the clinical trial protocol requirements to complete the trial.
• Female participants must meet the following criteria:1)Surgically sterilized or postmenopausal for ≥2 years, or women of childbearing potential (not menopausal or menopausal \<2 years) with a negative pregnancy test and willing to use effective physical contraception (e.g., condoms, intrauterine device) from enrollment until 6 months after full immunization. 2)Agree not to breastfeed from enrollment until 6 months after full immunization.
• Axillary temperature ≤37.0°C.

You may not qualify if:

• A history of herpes zoster.
• A history of varicella or herpes zoster vaccination.
• Close contact with a varicella/herpes zoster patient within the past year.
• Received immunoglobulin and/or any blood products within 3 months before vaccination.
• Received immunosuppressive treatment within 3 months prior to vaccination (e.g., systemic corticosteroids for ≥14 days, at a dose ≥2 mg/kg/day or ≥20 mg/day of prednisone, or an equivalent dose of prednisone) (excluding inhaled, intra-articular, and topical steroids).
• A history of severe allergic reactions to any vaccine or medication (e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reactions, severe urticaria, etc.), or a family history of severe allergies.
• Immunocompromised or diagnosed with congenital or acquired immune deficiency diseases, or infected with Human Immunodeficiency Virus (HIV).
• A history of seizures, epilepsy, encephalopathy (such as congenital brain malformation, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction \[except for infarction without sequelae or lacunar infarction\], brain infections, or brain damage caused by chemical drug poisoning), or psychiatric disorders, or a family history of psychiatric disorders; or other serious neurological diseases.
• Inadequate time interval between vaccination and other vaccines (e.g., inactivated or recombinant subunit vaccines within 14 days prior to vaccination, live attenuated vaccines, viral vector vaccines, or mRNA vaccines within 28 days prior to vaccination).
• Acute illness or an acute exacerbation of a chronic disease within 3 days prior to vaccination, or use of antipyretic, analgesic, or antihistamine medications within 3 days prior to vaccination.
• Suffering from severe infectious skin diseases.
• Ongoing or long-term alcohol and/or drug abuse history (Note: for the past three months, males drinking more than 14 standard drinks per week, females more than 7 standard drinks per week. One standard drink contains 14g of alcohol, equivalent to 360mL of beer, 45mL of liquor at 40% alcohol, or 150mL of wine. Drug abuse refers to the repeated or excessive use of drugs with dependence potential unrelated to recognized medical needs, for non-medical purposes).
• A history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection.
• Severe liver or kidney disease, complications from diabetes, severe cardiovascular diseases, or uncontrolled hypertension despite medication.
• Asplenia or functional asplenia, or any condition leading to splenectomy.

Sponsors & Collaborators

• Yither Biotechnology Co., Ltd: collaborator
• Ab&B Bio-tech Co., Ltd.JS: lead

Study Sites (1)

Xiangcheng County Center for Disease Control and Prevention

Xuchang, Henan, China

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zhiqiang Xie, Master

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: February 16, 2025
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 16, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)