Herpes ZosterPhase 1NCT05636436

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

A Phase 1 study testing Low Dose Recombinant Herpes Zoster Vaccine (CHO cells), High Dose Recombinant Herpes Zoster Vaccine (CHO cells) and Low dose adjuvant in people with Herpes Zoster, run by MAXVAX Biotechnology Limited Liability Company at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster
What is being tested?: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells), High Dose Recombinant Herpes Zoster Vaccine (CHO cells) and Low dose adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 132 participants
Where: 1 siteChina
Study dates: 7 Dec 2022to 10 Sep 2025
Phase: Phase 1
Are there results?: None posted in the registry

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Yanjin District Center for Disease Control and Prevention
Xinxiang, Henan, 453200

Other trials in China

About this study

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

Read the 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.

Conditions: Herpes Zoster
Being tested: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells), High Dose Recombinant Herpes Zoster Vaccine (CHO cells), Low dose adjuvant, High dose adjuvant, Positive control
Medical subject headings: Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)Biological
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
High Dose Recombinant Herpes Zoster Vaccine (CHO cells)Biological
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
Low dose adjuvantBiological
0.5 mL per dose, containing low dose MA105 adjuvant.
High dose adjuvantBiological
0.5 mL per dose, containing high dose MA105 adjuvant.
Positive controlBiological
Also called Shingrix®
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
PlaceboBiological
Also called Saline for injection
0.5 mL per dose, containing 4.5 mg sodium chloride.

Study groups in NCT05636436
Study group	Role	What they receive
Low dose vaccine group in adults aged 18 to 49 years	Experimental	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). Receives: Biological: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)
Low dose adjuvant group in adults aged 18 to 49 years	Experimental	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). Receives: Biological: Low dose adjuvant
High dose vaccine group in adults aged 18 to 49 years	Experimental	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). Receives: Biological: High Dose Recombinant Herpes Zoster Vaccine (CHO cells)
High dose adjuvant group in adults aged 18 to 49 years	Experimental	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). Receives: Biological: High dose adjuvant
Placebo group in adults aged 18 to 49 years	Placebo comparator	Subjects aged 18 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Placebo
Low dose vaccine group in adults aged 50 years and older	Experimental	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). Receives: Biological: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)
Low dose adjuvant group in adults aged 50 years and older	Experimental	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). Receives: Biological: Low dose adjuvant
High dose vaccine group in adults aged 50 years and older	Experimental	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). Receives: Biological: High Dose Recombinant Herpes Zoster Vaccine (CHO cells)
High dose adjuvant group in adults aged 50 years and older	Experimental	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). Receives: Biological: High dose adjuvant
Shingrix® group in adults aged 50 years and older	Active comparator	Subjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Positive control
Placebo group in adults aged 50 years and older	Placebo comparator	Subjects aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 30 minutes after each vaccination.
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.
Measured: Within 7 days after each vaccination.
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.
Measured: Day 8 to 30 after each vaccination.
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.
Measured: Within 30 days after each vaccination.
Incidence of abnormal and clinically significant laboratory test results
Laboratory test includes hematology, blood biochemistry and urine analysis.
Measured: Day 4 after each vaccination .

Secondary outcomes (25)

Incidence of Serious Adverse Event
Incidence of Serious Adverse Event (SAE) from the first vaccination to 12 months after full vaccination.
Measured: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Potential Immune Mediated Disorder
Incidence of Potential Immune Mediated Disorder (pIMD) from the first vaccination to 12 months after full vaccination.
Measured: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Measured: Prior to each vaccination (Day 0, Day 60).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Measured: Day 14 after each vaccination (Day 14, Day 74).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Measured: Month 1 after each vaccination (Day 30, Day 90).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Measured: Month 6 and 12 after the second vaccination (Day 240, Day 420).
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.
Measured: Prior to the second vaccination (Day 60).
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.
Measured: Day 14 after each vaccination (Day 14, Day 74).
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.
Measured: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Measured: Prior to each vaccination (Day 0, Day 60).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Measured: Day 14 after each vaccination (Day 14, Day 74).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Measured: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Measured: Month 6 and 12 after the second vaccination (Day 240, Day 420).
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).
Measured: Prior to the second vaccination (Day 60).
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).
Measured: Day 14 after each vaccination (Day 14, Day 74).
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).
Measured: Month 1 after each vaccination (Day 30, Day 90)
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).
Measured: Prior to the second vaccination (Day 60).
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).
Measured: Day 14 after each vaccination (Day 14, Day 74).
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).
Measured: Month 1 after each vaccination (Day 30, Day 90).
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).
Measured: Prior to the first vaccination (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).
Measured: Month 1 after the second vaccination (Day 90).
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).
Measured: Month 6, 12 after the second vaccination (Day 240, Day 420).
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.
Measured: Prior to the first vaccination (Day 0).
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.
Measured: Month 1 after the second vaccination (Day 90).
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.
Measured: Month 6, 12 after the second vaccination (Day 240, Day 420)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202210 Sep 2025

First posted5 Dec 2022
Study start7 Dec 2022
Primary completion23 May 2025
Study completion10 Sep 2025

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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05636436
Sponsor's protocol ID: MKKCT-100-001
Status last verified: Oct 2026
First submitted: 16 Nov 2022
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
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RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05636436
Acronym / sponsor ID: MKKCT-100-001
Conditions: Herpes Zoster
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: MAXVAX Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
Collaborators: Henan Center for Disease Control and Prevention
Study start: 7 Dec 2022 (actual)
Primary completion: 23 May 2025 (actual)
Study completion: 10 Sep 2025 (actual)
First posted: 5 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 11

Arm	Type	Receives
Low dose vaccine group in adults aged 18 to 49 years	Experimental	Biological: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)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).
Low dose adjuvant group in adults aged 18 to 49 years	Experimental	Biological: Low dose adjuvantSubjects aged 18 to 49 years will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
High dose vaccine group in adults aged 18 to 49 years	Experimental	Biological: High Dose Recombinant Herpes Zoster Vaccine (CHO cells)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).
High dose adjuvant group in adults aged 18 to 49 years	Experimental	Biological: High dose adjuvantSubjects aged 18 to 49 years will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Placebo group in adults aged 18 to 49 years	Placebo comparator	Biological: PlaceboSubjects aged 18 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Low dose vaccine group in adults aged 50 years and older	Experimental	Biological: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)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).
Low dose adjuvant group in adults aged 50 years and older	Experimental	Biological: Low dose adjuvantSubjects aged 50 years and older will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
High dose vaccine group in adults aged 50 years and older	Experimental	Biological: High Dose Recombinant Herpes Zoster Vaccine (CHO cells)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).
High dose adjuvant group in adults aged 50 years and older	Experimental	Biological: High dose adjuvantSubjects aged 50 years and older will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Shingrix® group in adults aged 50 years and older	Active comparator	Biological: Positive controlSubjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).
Placebo group in adults aged 50 years and older	Placebo comparator	Biological: PlaceboSubjects aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.	Biological	Low dose vaccine group in adults aged 18 to 49 years, Low dose vaccine group in adults aged 50 years and older
High Dose Recombinant Herpes Zoster Vaccine (CHO cells)0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.	Biological	High dose vaccine group in adults aged 18 to 49 years, High dose vaccine group in adults aged 50 years and older
Low dose adjuvant0.5 mL per dose, containing low dose MA105 adjuvant.	Biological	Low dose adjuvant group in adults aged 18 to 49 years, Low dose adjuvant group in adults aged 50 years and older
High dose adjuvant0.5 mL per dose, containing high dose MA105 adjuvant.	Biological	High dose adjuvant group in adults aged 18 to 49 years, High dose adjuvant group in adults aged 50 years and older
Positive controlAlso: Shingrix®0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.	Biological	Shingrix® group in adults aged 50 years and older
PlaceboAlso: Saline for injection0.5 mL per dose, containing 4.5 mg sodium chloride.	Biological	Placebo group in adults aged 18 to 49 years, Placebo group in adults aged 50 years and older

Primary outcome

The incidence and severity of adverse events
Time frame: Within 30 minutes after each vaccination.
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
Time frame: Within 7 days after each vaccination.
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
Time frame: Day 8 to 30 after each vaccination.
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
Time frame: Within 30 days after each vaccination.
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
Time frame: Day 4 after each vaccination .
Laboratory test includes hematology, blood biochemistry and urine analysis.

25 secondary outcomes

Incidence of Serious Adverse Event
Time frame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Potential Immune Mediated Disorder
Time frame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Time frame: Prior to each vaccination (Day 0, Day 60).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Time frame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Time frame: Prior to the second vaccination (Day 60).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Time frame: Prior to each vaccination (Day 0, Day 60).
Positive rate of anti-gE antibody and anti-VZV antibody
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Positive rate of anti-gE antibody and anti-VZV antibody
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Time frame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
Time frame: Prior to the second vaccination (Day 60).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
Time frame: Month 1 after each vaccination (Day 30, Day 90)
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
Time frame: Prior to the second vaccination (Day 60).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
Time frame: Prior to the first vaccination (Day 0).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
Time frame: Month 1 after the second vaccination (Day 90).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
Time frame: Month 6, 12 after the second vaccination (Day 240, Day 420).
Cellular immune response
Time frame: Prior to the first vaccination (Day 0).
Cellular immune response
Time frame: Month 1 after the second vaccination (Day 90).
Cellular immune response
Time frame: Month 6, 12 after the second vaccination (Day 240, Day 420)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yanxia Wang principal investigator

Henan Center for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and severity of adverse events (time frame: Within 30 minutes after each vaccination.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05636436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.