Herpes Zoster (HZ)Phase 2NCT07311148

A Immunogenicity and Safety Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 40 Years and Older

A Phase 2 study testing Low dose antigen and low dose adjuvant of LYB004, Low dose antigen and high dose adjuvant of LYB004 and High dose antigen and low dose adjuvant of LYB004 in people with Herpes Zoster (HZ) and Shingles, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This phase 2 study in China will evaluate the immunogenicity and safety of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older. Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster (HZ), Shingles, VZV
What is being tested?: Low dose antigen and low dose adjuvant of LYB004, Low dose antigen and high dose adjuvant of LYB004 and High dose antigen and low dose adjuvant of LYB004
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 840 participants
Where: 1 siteChina
Study dates: 23 Oct 2025to Dec 2026
Phase: Phase 2

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

Who may be able to join

Residents aged 40 years and older (at the time of screening), regardless of gender;
Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form;
Participants are able to attend all planned follow-up visits and comply with the protocol requirements;
Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential (excluding those who have undergone tubal ligation, bilateral oophorectomy, or hysterectomy) and male participants should practice effective contraception and avoid pregnancy plans, as well as sperm or egg donation plans from the time of enrollment until 6 months after the full course of vaccination. Effective contraceptive methods include oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.

Who cannot join

Axillary temperature ≥ 37.0°C;
History of herpes zoster before vaccination with the investigational vaccine;
Previous vaccination against HZ or varicella;
Has had close contact with patients with varicella/herpes zoster within 6 months before vaccination with the investigational vaccine;
Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
Those who have received blood or blood-related products, including immunoglobulins, within 3 months before the first dose of vaccination, or have planned to use them during the study period;

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Individual with the following diseases: ① Have acute diseases or are in the acute exacerbation period of chronic diseases, or take antipyretic, analgesic, and anti-allergic drugs within 3 days before vaccination; ② Allergies to any component of the study vaccine, or have a history of severe allergic reactions to any vaccination; ③ History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc. causing brain nerve tissue damage, etc.) and mental illness, or a family history of mental illness; ④ Asplenia, or functional asplenia; ⑤Primary or secondary immunodeficiency, or diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases; ⑥ Chronic administration (≥14 consecutive days) of glucocorticoid (reference value for dose: ≥ 2mg/kg/day or ≥ 20mg/day prednisone or equivalent) or other immunosuppressive agents within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (<14 consecutive days) of oral corticosteroids; ⑦ Severe cardiovascular diseases (pulmonary heart disease, pulmonary edema, etc.), severe liver and kidney diseases, complicated diabetes; ⑧ History of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection;⑨Severe hypertension that cannot be controlled by medication (on-site measurement: systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg);
Those tested positive for antibodies to the Human Immunodeficiency Virus (HIV) at screening.;
History of long-term alcohol abuse and/or drug abuse;
Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical study;
Exclusion criteria for specific populations: lactating or pregnant women during the clinical research period, or women of childbearing age with a positive pregnancy test before vaccination;
Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Hengnan County Center for Disease Control and Prevention
Hengyang, Hunan

Other trials in China

About this study

Official title: A Phase Ⅱ, Randomized, Observer-blinded, Parallel-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

This phase 2 study in China will evaluate the immunogenicity and safety of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

Read the detailed description

A randomized, observer-blinded, parallel-controlled trial will be conducted to observe the immunogenicity and safety of LYB004 in adults aged 40 years and older. A total of 840 participants aged 40 years and older will be enrolled. Four formulations of LYB004 will be provided: two dose levels of antigen and two dose levels of adjuvant. Participants aged 40-49 years old will randomly receive four investigational vaccines and the placebo in a 2:2:2:2:1 ratio. Participants aged 50 years and older will randomly receive four investigational vaccines, positive control and the placebo in a 2:2:2:2:2:1 ratio.

Conditions: Herpes Zoster (HZ), Shingles, VZV, Recombinant Zoster Vaccine
Being tested: Low dose antigen and low dose adjuvant of LYB004, Low dose antigen and high dose adjuvant of LYB004, High dose antigen and low dose adjuvant of LYB004, High dose antigen and high dose adjuvant of LYB004, Placebo
Keywords: herpes zoster, varicella-zoster virus, Virus-like particles, Recombinant protein vaccine, Glycoprotein E
Medical subject headings: Herpes Zoster, Chickenpox

What participants receive

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

Low dose antigen and low dose adjuvant of LYB004Biological
0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01C.
Low dose antigen and high dose adjuvant of LYB004Biological
0.5 mL per dose, containing 25 μg VZV-gEM adjuvanted with A01B.
High dose antigen and low dose adjuvant of LYB004Biological
0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01C.
High dose antigen and high dose adjuvant of LYB004Biological
0.5 mL per dose, containing 50 μg VZV-gEM adjuvanted with A01B.
PlaceboBiological
0.5 mL per dose, without antigen and adjuvant.
Positive controlBiological
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

Study groups in NCT07311148
Study group	Role	What they receive
Low dose antigen and low dose adjuvant of LYB004	Experimental	Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (low dose antigen and low dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Low dose antigen and low dose adjuvant of LYB004
Low dose antigen and high dose adjuvant of LYB004	Experimental	Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (low dose antigen and high dose adjuvant ) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Low dose antigen and high dose adjuvant of LYB004
High dose antigen and low dose adjuvant of LYB004	Experimental	Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (high dose antigen and low dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: High dose antigen and low dose adjuvant of LYB004
High dose antigen and high dose adjuvant of LYB004	Experimental	Participants aged 40 years and older will be vaccinated with 2 doses of LYB004 (high dose antigen and high dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: High dose antigen and high dose adjuvant of LYB004
Placebo	Placebo comparator	Participants aged 40 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). Receives: Biological: Placebo
Positive control	Active comparator	Participants 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

What is being measured

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

The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: 30 days after second vaccination
The geometric mean titer (GMT) of anti-VZV antibody
Measured by fluorescent antibody to the membrane antigen (FAMA).
Measured: 30 days after second vaccination

Secondary outcomes (12)

Occurrence of immediate adverse events
The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination
Measured: Within 30 minutes after each vaccination
Incidence of solicited AE
Occurrence and severity of solicited local injection site reactions for 7 days (Day 0-Day 7) following each vaccination. (i.e., pain, redness, swelling).
Occurrence and severity of solicited systemic reactions for 7 days (Day 0-Day 7) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever).
Measured: Within 0-7 days after each vaccination
Incidence of unsolicited AEs
The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Days 0~30 after the study intervention. vaccination
Measured: Within 30 days after each vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) from the first vaccination up to 12 months after the second vaccination
Measured: From the first vaccination up to 12 months after the second vaccination
The geometric mean titer (GMT) of anti-VZV antibody
Measured by fluorescent antibody to the membrane antigen (FAMA).
Measured: 60 days after first vaccination, 6 months and 12 months after second vaccination
The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: 60 days after first vaccination, 6 months and 12 months after second vaccination
The seroconversion rate of anti-Varicella Zoster Virus (VZV) antibody
Seroconversion refers to at least a 4-fold increase in the anti-Varicella Zoster Virus (VZV) antibody titer at the endpoint as compared to the prevaccination titer if prevaccination titer is above the lower limit of quantification (LLOQ) or a 4-fold increase at the endpoint as compared to LLOQ value if prevaccination concentration is lower than LLOQ.
Measured: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
The seroconversion rate of anti-glycoprotein E (gE) antibody
Seroconversion refers to at least a 4-fold increase in the anti-glycoprotein E (gE) antibody concentration at the endpoint as compared to the prevaccination concentration if prevaccination concentration is above the lower limit of quantification (LLOQ) or a 4-fold increase at the endpoint as compared to LLOQ value if prevaccination concentration is lower than LLOQ.
Measured: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
The geometric mean fold rise (GMFR) of anti-VZV antibody
Change from prevaccination in geometric mean fold rise of anti-VZV antibody titer.
Measured: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
The GMFR of anti-gE antibody
Change from prevaccination in geometric mean fold rise of anti-gE antibody concentration.
Measured: 60 days after first vaccination, 30 days, 6 months and 12 months after second vaccination
Frequencies of CD4+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study
The frequencies of CD4+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD4+ T cells, and the cell mediated immunity (CMI) response rates at 30 days and 6 months after second vaccination.
Measured: 30 days, 6 months and 12 months after second vaccination
Frequencies of CD8+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD8+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study
The frequencies of CD8+ T cells secreting at least two of gE specific activation markers (IFN-γ, IL-2, TNF-α, CD40L) per 10^6 CD8+ T cells, and the cell mediated immunity (CMI) response rates at 30 days after first vaccination, 30 days and 6 months after second vaccination.
Measured: 30 days, 6 months and 12 months after second vaccination

Timeline

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

23 Oct 2025Dec 2026

First posted30 Dec 2025
Study start23 Oct 2025
Primary completionJan 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Herpes Zoster (HZ)Studies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 840 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07311148
Sponsor's protocol ID: LYB004/CT-CHN-201
Status last verified: Dec 2025
First submitted: 16 Dec 2025
Last updated: 30 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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?

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