Herpes Zoster (HZ)Phase 1NCT06874842
Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
A Phase 1 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), run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.
Trial summary
This phase 1 study in China will evaluate the safety and immunogenicity 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)
- 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
- 92 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2025to Oct 2026
- Phase
- Phase 1
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 ≥ 37.3°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;
- Have been injected with gamma globulin or intravenous immunoglobulin within 3 months before vaccination;
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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);
- Abnormal laboratory test indicators specified in the protocol before vaccination and determined by the clinical investigator to be of clinical significance;
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Center for Disease Control and Prevention
Meizhou
Weihua Huang, 8613690896555, 2051274292@qq.com
About this study
Official title: A Phase I, Randomized, Observer-blinded, Parallel-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.
Read the detailed description
A randomized, observer-blinded, positive-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB004 in adults aged 40 years and older. A total of 92 healthy subjects will be enrolled and stratified by age (40-49，50-59 years and ≥60 years in a 5:6:8 ratio). Four formulations of LYB004 will be provided, two dose levels of antigen and two dose levels of adjuvant.
A sentinel and escalating dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be enrolled in one of six cohorts, including Cohort 1 (40-49 years, low dose, n=10), Cohort 2 (50-59 years, low dose, n=12), Cohort 3 (≥60 years, low dose, n=24), Cohort 4 (40-49 years, high dose, n=10), Cohort 5 (50-59 years, high dose, n=12), and Cohort 6 (≥60 years, high dose, n=24). In Cohort 1 and Cohort 4, three sentinels each were set up, and they were randomly vaccinated with the investigational vaccine (low dose adjuvant), the investigational vaccine (high dose adjuvant), or a placebo in a 1:1:1 ratio. The remaining participants were randomly vaccinated in a 3:3:1 ratio with the low dose investigational vaccine (low dose adjuvant), the low dose investigational vaccine (high dose adjuvant), or a placebo. In Cohort 2 and Cohort 5, four sentinels each were set up, and they were randomly vaccinated with the investigational vaccine (low dose adjuvant), the investigational vaccine (high dose adjuvant), a positive control/Shingrix®, or a placebo in a 1:1:1:1 ratio. The remaining participants were randomly vaccinated in a 3:3:1:1 ratio with the same options. In Cohort 3 and Cohort 6, four sentinels each were also set up, and they were randomly vaccinated in a 1:1:1:1 ratio with the investigational vaccine (low dose adjuvant), the investigational vaccine (high dose adjuvant), a positive control/Shingrix®, or a placebo. The remaining participants were randomly vaccinated in a 7:7:3:3 ratio with the same options. The two-dose immunization schedule will be adopted, that is, LYB004 or Shingrix® or placebo will be intramuscularly injected on Day 0 and Day 60, respectively.
- Conditions
- Herpes Zoster (HZ)
- 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, shingles, varicella zoster virus, Virus-Like Particles, vaccine
- 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 a total of 25 μg VZV-gEM adjuvanted with A01C.
Low dose antigen and high dose adjuvant of LYB004Biological
0.5 mL per dose, containing a total of 25 μg VZV-gEM adjuvanted with A01B.
High dose antigen and low dose adjuvant of LYB004Biological
0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01C.
High dose antigen and high dose adjuvant of LYB004Biological
0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01B.
PlaceboBiological
0.5 mL per dose, without antigen and 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.
| Study group | Role | What they receive |
|---|---|---|
| Low dose antigen and low dose adjuvant of LYB004 | Experimental | Subjects 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 | Subjects 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 |
| Placebo | Placebo comparator | Subjects 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 | 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 |
| High dose antigen and low dose adjuvant of LYB004 | Experimental | Subjects 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 | Subjects 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 14 days (Day 0-Day 14) following each vaccination. (i.e., pain, redness, swelling).
Occurrence and severity of solicited systemic reactions for 14 days (Day 0-Day 14) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever).
Measured: Within 0-14 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
Incidence of clinically significant abnormalities in clinical laboratory tests
The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, coagulation function, and urinalysis) on Day 3 after each vaccination
Measured: 3 days after each vaccination
Secondary outcomes (9)
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 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: 30 days and 60 days after first vaccination, 14 days, 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: 30 days and 60 days after first vaccination, 14 days, 30 days, 6 months and 12 months after second vaccination
The geometric mean titer (GMT) of anti-VZV antibody
Measured by fluorescent antibody to the membrane antigen (FAMA).
Measured: 30 days and 60 days after first vaccination, 14 days, 30 days, 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: 30 days and 60 days after first vaccination, 14 days, 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: 30 days and 60 days after first vaccination, 14 days, 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: 30 days and 60 days after first vaccination, 14 days, 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 106 CD4+ 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 after first vaccination, 30 days and 6 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 after first vaccination, 30 days and 6 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.
- First posted13 Mar 2025
- Study start13 Mar 2025
- Primary completionFeb 2026 (estimated)
- Study completionOct 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 92 healthy subjects will be enrolled and stratified by age (40-49 years，50-59 years and ≥60 years in a 5:6:8 ratio). The younger cohort (aged 40 to 49 years) will consist of 20 subjects, and these 20 subjects will be enrolled into five subgroups, including four vaccine groups, and placebo group, with the ratio of 1:1:1:1:1. The middle age cohort (aged 50 to 59 years) will consist of 24 subjects, and these 24 subjects will be enrolled into six subgroups, including four vaccine groups, placebo group and positive control group/Shingrix® group, with the ratio of 1:1:1:1:1:1. The older cohort (aged ≥60 years) will consist of 48 subjects, and these 48 subjects will be enrolled into six subgroups, including four vaccine groups, placebo group and positive control group/Shingrix® group, with the ratio of 1:1:1:1:1:1. The investigational vaccine group and the control group (placebo and positive control) are enrolled parallelly.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renfeng Fan, Principal investigator, Guangdong Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874842
- Sponsor's protocol ID
- LYB004/CT-CHN-101
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No