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Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above

Primary Purpose

Herpes Zoster

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Low dose Recombinant Herpes Zoster Vaccine (CHO cells)
High dose Recombinant Herpes Zoster Vaccine (CHO cells)
Positive control
Placebo
Sponsored by
MAXVAX Biotechnology Limited Liability Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Permanent residents aged 30 years and above; Subjects voluntarily agree to participate in the study and signed an informed consent; Be able to participate in all scheduled visits and comply with the protocol requirements. Exclusion Criteria: Axillary temperature>37.0℃; History of herpes zoster within 5 years before vaccination; Prior vaccination with chickenpox vaccine or herpes zoster vaccine; Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination; Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination; Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination; Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination; A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination; History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history; Asplenia or functional asplenia, or splenectomy caused by any condition; Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases; Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable; Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication; History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications; Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg); Current or history of alcohol and/or drug abuse; Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.

Sites / Locations

  • Yanjin Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Low dose vaccine group in adults aged 30 to 49 years

High dose vaccine group in adults aged 30 to 49 years

Placebo group in adults aged 30 to 49 years

Low dose vaccine group in adults aged 50 years and older

High dose vaccine group in adults aged 50 years and older

Shingrix® group in adults aged 50 years and older

Placebo group in adults aged 50 years and older

Arm Description

Participants aged 30 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Participants aged 30 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Participants aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Participants aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).

Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).

Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Outcomes

Primary Outcome Measures

Geometric mean concentration (GMC) of anti-gE antibody
Measured by ELISA.
Seropositivity rate of anti-gE antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Seroresponse rate of anti-gE antibody
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Four-fold increase rate of anti-gE antibody concentration
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Cell-Mediated Immunity (CMI) response
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL-2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Vaccine Response Rate (VRR)
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence and severity of adverse events
Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence and severity of adverse events
Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.

Secondary Outcome Measures

The incidence of Serious Adverse Events
Incidence of Serious Adverse Events (SAEs) from the first vaccination to 12 months after the last vaccination.
Potential Immune-Mediated Diseases
Incidence of Potential Immune-Mediated Diseases (pIMDs) from the first vaccination to 12 months after the last vaccination.
Geometric mean concentration (GMC) of anti-VZV antibody
measured by ELISA.
Seropositivity rate of anti-VZV antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Seroresponse rate of anti-VZV antibody
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Geometric Mean Fold Rise (GMFR) of anti-VZV antibody
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Four-fold increase rate of anti-VZV antibody
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Geometric mean concentration (GMC) of anti-gE antibody
measured by ELISA.
Seropositivity rate of anti-gE antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Geometric mean concentration (GMC) of anti-VZV antibody
measured by ELISA.
Seropositivity rate of anti-VZV antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Cell-Mediated Immunity (CMI) response
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL 2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Vaccine Response Rate (VRR)
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.

Full Information

First Posted
May 4, 2023
Last Updated
October 17, 2023
Sponsor
MAXVAX Biotechnology Limited Liability Company
Collaborators
Henan Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05856084
Brief Title
Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
Official Title
A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MAXVAX Biotechnology Limited Liability Company
Collaborators
Henan Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.
Detailed Description
The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 30 to 49 years and 50 years and older. A total of 924 participants will be enrolled, including 396 participants aged 30 to 49 years and 528 participants aged 50 years and older. Participants aged 30 to 49 years will be randomized into three subgroups (low dose vaccine group, high dose vaccine group and placebo group) in a 1:1:1 ratio. Participants aged 50 years and older will be randomized into four subgroups (low dose vaccine group, high dose vaccine group, Shingrix® group and placebo group) in a 1:1:1:1 ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
924 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose vaccine group in adults aged 30 to 49 years
Arm Type
Experimental
Arm Description
Participants aged 30 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
High dose vaccine group in adults aged 30 to 49 years
Arm Type
Experimental
Arm Description
Participants aged 30 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
Placebo group in adults aged 30 to 49 years
Arm Type
Placebo Comparator
Arm Description
Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
Low dose vaccine group in adults aged 50 years and older
Arm Type
Experimental
Arm Description
Participants aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
High dose vaccine group in adults aged 50 years and older
Arm Type
Experimental
Arm Description
Participants aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
Shingrix® group in adults aged 50 years and older
Arm Type
Active Comparator
Arm Description
Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
Placebo group in adults aged 50 years and older
Arm Type
Placebo Comparator
Arm Description
Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Intervention Type
Biological
Intervention Name(s)
Low dose Recombinant Herpes Zoster Vaccine (CHO cells)
Intervention Description
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
Intervention Type
Biological
Intervention Name(s)
High dose Recombinant Herpes Zoster Vaccine (CHO cells)
Intervention Description
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
Intervention Type
Biological
Intervention Name(s)
Positive control
Other Intervention Name(s)
Shingrix®
Intervention Description
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline for injection
Intervention Description
0.5 mL per dose, containing 4.5 mg sodium chloride.
Primary Outcome Measure Information:
Title
Geometric mean concentration (GMC) of anti-gE antibody
Description
Measured by ELISA.
Time Frame
Month 1 after the last vaccination
Title
Seropositivity rate of anti-gE antibody
Description
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time Frame
Month 1 after the last vaccination
Title
Seroresponse rate of anti-gE antibody
Description
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Time Frame
Month 1 after the last vaccination
Title
Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration
Description
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time Frame
Month 1 after the last vaccination
Title
Four-fold increase rate of anti-gE antibody concentration
Description
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time Frame
Month 1 after the last vaccination
Title
Cell-Mediated Immunity (CMI) response
Description
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL-2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Time Frame
Month 1 after the last vaccination
Title
Vaccine Response Rate (VRR)
Description
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
Time Frame
Month 1 after the last vaccination
Title
The incidence and severity of adverse events
Description
Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time Frame
Within 30 minutes after each vaccination
Title
The incidence and severity of adverse events
Description
Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time Frame
Within 7 days after each vaccination
Title
The incidence and severity of adverse events
Description
Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time Frame
Day 8 to 30 after each vaccination
Title
The incidence and severity of adverse events
Description
Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time Frame
Within 30 days after each vaccination
Secondary Outcome Measure Information:
Title
The incidence of Serious Adverse Events
Description
Incidence of Serious Adverse Events (SAEs) from the first vaccination to 12 months after the last vaccination.
Time Frame
From the first vaccination to 12 months after the last vaccination
Title
Potential Immune-Mediated Diseases
Description
Incidence of Potential Immune-Mediated Diseases (pIMDs) from the first vaccination to 12 months after the last vaccination.
Time Frame
From the first vaccination to 12 months after the last vaccination
Title
Geometric mean concentration (GMC) of anti-VZV antibody
Description
measured by ELISA.
Time Frame
Month 1 after the last vaccination
Title
Seropositivity rate of anti-VZV antibody
Description
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time Frame
Month 1 after the last vaccination
Title
Seroresponse rate of anti-VZV antibody
Description
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Time Frame
Month 1 after the last vaccination
Title
Geometric Mean Fold Rise (GMFR) of anti-VZV antibody
Description
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time Frame
Month 1 after the last vaccination
Title
Four-fold increase rate of anti-VZV antibody
Description
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time Frame
Month 1 after the last vaccination
Title
Geometric mean concentration (GMC) of anti-gE antibody
Description
measured by ELISA.
Time Frame
At 6, 12 and 24 months after the last vaccination
Title
Seropositivity rate of anti-gE antibody
Description
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time Frame
At 6, 12 and 24 months after the last vaccination
Title
Geometric mean concentration (GMC) of anti-VZV antibody
Description
measured by ELISA.
Time Frame
At 6, 12 and 24 months after the last vaccination
Title
Seropositivity rate of anti-VZV antibody
Description
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time Frame
At 6, 12 and 24 months after the last vaccination
Title
Cell-Mediated Immunity (CMI) response
Description
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL 2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Time Frame
At 6, 12 and 24 months after the last vaccination
Title
Vaccine Response Rate (VRR)
Description
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
Time Frame
At 6, 12 and 24 months after the last vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Permanent residents aged 30 years and above; Subjects voluntarily agree to participate in the study and signed an informed consent; Be able to participate in all scheduled visits and comply with the protocol requirements. Exclusion Criteria: Axillary temperature>37.0℃; History of herpes zoster within 5 years before vaccination; Prior vaccination with chickenpox vaccine or herpes zoster vaccine; Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination; Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination; Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination; Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination; A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination; History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history; Asplenia or functional asplenia, or splenectomy caused by any condition; Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases; Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable; Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication; History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications; Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg); Current or history of alcohol and/or drug abuse; Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanxia Wang
Organizational Affiliation
Henan Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yanjin Center for Disease Control and Prevention
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453200
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above

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