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Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above

Primary Purpose

Herpes Zoster

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)
High Dose Recombinant Herpes Zoster Vaccine (CHO cells)
Low dose adjuvant
High dose adjuvant
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

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

Inclusion Criteria: Permanent residents aged 18 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); Abnormal and clinically significant laboratory test results as determined by the investigator before vaccination; 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 District 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 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Low dose vaccine group in adults aged 18 to 49 years

Low dose adjuvant group in adults aged 18 to 49 years

High dose vaccine group in adults aged 18 to 49 years

High dose adjuvant group in adults aged 18 to 49 years

Placebo group in adults aged 18 to 49 years

Low dose vaccine group in adults aged 50 years and older

Low dose adjuvant group in adults aged 50 years and older

High dose vaccine group in adults aged 50 years and older

High dose adjuvant 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

Subjects aged 18 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).

Subjects aged 18 to 49 years will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).

Subjects aged 18 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).

Subjects aged 18 to 49 years will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).

Subjects aged 18 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Subjects 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).

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

Subjects 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).

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

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

Subjects 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

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.
Incidence of abnormal and clinically significant laboratory test results
Laboratory test includes hematology, blood biochemistry and urine analysis.

Secondary Outcome Measures

Incidence of Serious Adverse Event
Incidence of Serious Adverse Event (SAE) from the first vaccination to 12 months after full vaccination.
Potential Immune Mediated Disorder
Incidence of Potential Immune Mediated Disorder (pIMD) from the first vaccination to 12 months after full vaccination.
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was <Cut-off value at baseline.
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was <Cut-off value at baseline.
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was <Cut-off value at baseline.
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at 1 month after each vaccination compared with that at baseline (Day 0).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at month 1 after each vaccination compared with that at baseline (Day 0).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells <Cut-off value at baseline.
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells <Cut-off value at baseline.
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells <Cut-off value at baseline.

Full Information

First Posted
November 16, 2022
Last Updated
February 1, 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
NCT05636436
Brief Title
Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above
Official Title
A Phase I, Single Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (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 safety and tolerability of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 18 years and older, and to preliminarily explore immunogenicity.
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 18 to 49 years and 50 years and older, with progression from low dose level to high dose level and younger age group to the older age group based on assessment of safety and tolerability. The younger cohort (aged 18 to 49 years) will consist of 60 subjects, 30 per dose level, and these 30 subjects will be randomized into three subgroups, including vaccine group, adjuvant group and normal saline group, with randomization ratio of 2:2:1. The older cohort (aged 50 years and older) will consist of 72 subjects, 36 per dose level, and these 36 subjects will be randomized into four subgroups, including vaccine group, adjuvant group, Shingrix® group and normal saline group, with randomization ratio of 2:2:1:1.

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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose vaccine group in adults aged 18 to 49 years
Arm Type
Experimental
Arm Description
Subjects aged 18 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
Low dose adjuvant group in adults aged 18 to 49 years
Arm Type
Experimental
Arm Description
Subjects aged 18 to 49 years will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
High dose vaccine group in adults aged 18 to 49 years
Arm Type
Experimental
Arm Description
Subjects aged 18 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
High dose adjuvant group in adults aged 18 to 49 years
Arm Type
Experimental
Arm Description
Subjects aged 18 to 49 years will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Arm Title
Placebo group in adults aged 18 to 49 years
Arm Type
Placebo Comparator
Arm Description
Subjects aged 18 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
Subjects 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
Low dose adjuvant group in adults aged 50 years and older
Arm Type
Experimental
Arm Description
Subjects aged 50 years and older will be vaccinated with 2 doses of low dose adjuvant 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
Subjects 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
High dose adjuvant group in adults aged 50 years and older
Arm Type
Experimental
Arm Description
Subjects aged 50 years and older will be vaccinated with 2 doses of high dose adjuvant 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
Subjects 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
Subjects 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)
Low dose adjuvant
Intervention Description
0.5 mL per dose, containing low dose MA105 adjuvant.
Intervention Type
Biological
Intervention Name(s)
High dose adjuvant
Intervention Description
0.5 mL per dose, containing high dose MA105 adjuvant.
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)
Saline for injection
Intervention Description
0.5 mL per dose, containing 4.5 mg sodium chloride.
Primary Outcome Measure Information:
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.
Title
Incidence of abnormal and clinically significant laboratory test results
Description
Laboratory test includes hematology, blood biochemistry and urine analysis.
Time Frame
Day 4 after each vaccination .
Secondary Outcome Measure Information:
Title
Incidence of Serious Adverse Event
Description
Incidence of Serious Adverse Event (SAE) from the first vaccination to 12 months after full vaccination.
Time Frame
From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Title
Potential Immune Mediated Disorder
Description
Incidence of Potential Immune Mediated Disorder (pIMD) from the first vaccination to 12 months after full vaccination.
Time Frame
From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Title
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Description
Measured by ELISA.
Time Frame
Prior to each vaccination (Day 0, Day 60).
Title
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Description
Measured by ELISA.
Time Frame
Day 14 after each vaccination (Day 14, Day 74).
Title
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Description
Measured by ELISA.
Time Frame
Month 1 after each vaccination (Day 30, Day 90).
Title
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Description
Measured by ELISA.
Time Frame
Month 6 and 12 after the second vaccination (Day 240, Day 420).
Title
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Description
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was <Cut-off value at baseline.
Time Frame
Prior to the second vaccination (Day 60).
Title
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Description
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was <Cut-off value at baseline.
Time Frame
Day 14 after each vaccination (Day 14, Day 74).
Title
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Description
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was <Cut-off value at baseline.
Time Frame
Month 1 after each vaccination (Day 30, Day 90).
Title
Positive rate of anti-gE antibody and anti-VZV antibody
Description
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time Frame
Prior to each vaccination (Day 0, Day 60).
Title
Positive rate of anti-gE antibody and anti-VZV antibody
Description
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time Frame
Day 14 after each vaccination (Day 14, Day 74).
Title
Positive rate of anti-gE antibody and anti-VZV antibody
Description
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time Frame
Month 1 after each vaccination (Day 30, Day 90).
Title
Positive rate of anti-gE antibody and anti-VZV antibody
Description
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time Frame
Month 6 and 12 after the second vaccination (Day 240, Day 420).
Title
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
Description
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Time Frame
Prior to the second vaccination (Day 60).
Title
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
Description
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Time Frame
Day 14 after each vaccination (Day 14, Day 74).
Title
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
Description
The antibody concentration at 1 month after each vaccination compared with that at baseline (Day 0).
Time Frame
Month 1 after each vaccination (Day 30, Day 90)
Title
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
Description
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Time Frame
Prior to the second vaccination (Day 60).
Title
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
Description
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Time Frame
Day 14 after each vaccination (Day 14, Day 74).
Title
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
Description
The antibody concentration at month 1 after each vaccination compared with that at baseline (Day 0).
Time Frame
Month 1 after each vaccination (Day 30, Day 90).
Title
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
Description
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time Frame
Prior to the first vaccination (Day 0).
Title
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
Description
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time Frame
Month 1 after the second vaccination (Day 90).
Title
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
Description
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time Frame
Month 6, 12 after the second vaccination (Day 240, Day 420).
Title
Cellular immune response
Description
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells <Cut-off value at baseline.
Time Frame
Prior to the first vaccination (Day 0).
Title
Cellular immune response
Description
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells <Cut-off value at baseline.
Time Frame
Month 1 after the second vaccination (Day 90).
Title
Cellular immune response
Description
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells <Cut-off value at baseline.
Time Frame
Month 6, 12 after the second vaccination (Day 240, Day 420)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Permanent residents aged 18 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); Abnormal and clinically significant laboratory test results as determined by the investigator before vaccination; 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 District 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

Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above

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