Herpes ZosterPhase 1NCT06335849
A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years
A Phase 1 study testing LYB004 25µg, LYB004 50µg and SHINGRIX in people with Herpes Zoster, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in Australia.
Trial summary
This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- LYB004 25µg, LYB004 50µg and SHINGRIX
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Mar 2024to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A male or female aged 50 to 70 years inclusive at screening.
- Written informed consent obtained from the subject before any assessment is performed.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol. (e.g., complete the diary cards, and complete follow-up visits).
- Subjects must have a Body Mass Index (BMI) between ≥18.0 and ≤35.0 kg/m^2 at screening.
- Female subjects who are not pregnant or lactating. Female subjects with childbearing potential and their partners should use highly effective, medically accepted double-barrier contraception and will not have pregnancy and fertility plan until study completion.
- Female subjects of childbearing potential are defined as sexually mature women: 1) have not undergone hysterectomy, bilateral salpingectomy, and bilateral oophorectomy; 2) have had natural menses at any time in the preceding 12 consecutive months (without an alternative medical cause).
- Highly effective double-barrier contraception is defined as use of a condom AND one of the following: Birth control pills (The Pill), Depot or injectable birth control, Intrauterine device (IUD), Birth Control Patch (e.g., Ortho Evra), NuvaRing®, Implantable contraception (e.g., Implanon).
- Males participating in this study must agree to use highly effective, medically accepted double-barrier contraception (as described above) and refrain from donating sperm until study completion.
Who cannot join
- Tympanic temperature > 37.5°C at screening.
- History of HZ.
- Previous vaccination against HZ or varicella. Planned administration of VZV or HZ vaccination during the study (including an investigational or non-registered vaccine), except for the investigational vaccine.
- Received a live attenuated vaccine within 28 days before vaccination or received other vaccines within 14 days before vaccination.
- Received any immunoglobulins or blood/plasma products within 3 months prior to vaccination.
- Individuals with the following diseases: 1）Any acute disease or acute attack of chronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior to enrolment; 2）Allergies to any component of the investigational vaccine; 3）Subject has any clinically significant history of allergic conditions to other vaccines. 4）History of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders (bipolar disorder, schizophrenia, etc.) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 5）Asplenia, or functional asplenia; 6）Congenital or acquired immunodeficiency or autoimmune disease; 7）Chronic administration (≥14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/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; 8）Has severe cardiovascular diseases (cardiopulmonary disease, pulmonary edema), severe hepatic or renal diseases, and diabetes complications that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 9）History of thrombocytopenia or other coagulation disorders which may be contraindications for an IM; 10）Severe hypertension uncontrolled by medication with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; 11）Positive test for Hepatitis C virus (HCV), Hepatitis B surface antigen (HbsAg), Human immunodeficiency virus (HIV) at screening; 12）Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.
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- Clinically significant laboratory abnormalities determined by the investigator prior to vaccination.
- A positive urine drug test or alcohol breath test or a history of drug or alcohol abuse in the past 1 years.
- Recent participation in another clinical trial, with receipt of the investigational drug/vaccine within 30 days prior to screening. Current participation or those planning to participate in another clinical trial during the study.
- 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.
About this study
Official title: A Phase I, Randomized, Observer-blinded, Positive-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years
This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years.
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 50 to 70 years of age. A total of 48 healthy subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:1) to receive LYB004 or SHINGRIX. Two dose levels of LYB004 will be provided, low dose 25 μg and high dose 50 μg. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60, respectively.
- Conditions
- Herpes Zoster
- Being tested
- LYB004 25µg, LYB004 50µg, SHINGRIX
- Keywords
- Recombinant Zoster Vaccine, Glycoprotein E, Varicella-Zoster Virus, Herpes zoster, Shingles
- 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.
LYB004 25µgBiological
Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.
LYB004 50µgBiological
Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.
SHINGRIXBiological
Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 (LYB004 25µg) | Experimental | Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. Receives: Biological: LYB004 25µg |
| Treatment 2 (LYB004 50µg) | Experimental | Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. Receives: Biological: LYB004 50µg |
| Treatment 3 (SHINGRIX) | Active comparator | Subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. Receives: Biological: SHINGRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the reactogenicity of LYB004 vaccine
The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination
Measured: Within 30 minutes after each vaccination
Evaluate the safety and reactogenicity of LYB004 vaccine
The incidence and severity of any solicited local and systemic AEs and unsolicited AEs within 0-7 days after each vaccination
Measured: Within 0-7 days after each vaccination
Evaluate the safety of LYB004 vaccine
The incidence and severity of any AEs within 30 days after each vaccination
Measured: Within 30 days after each vaccination
Evaluate the safety and tolerability in laboratory tests of LYB004 vaccine
The occurrence of clinically significant laboratory abnormalities 3 days, 14 days after each vaccination and 90 days after the first vaccination
Measured: 3 days, 14 days after each vaccination and 90 days after the first vaccination
Evaluate the SAEs and AESIs of LYB004 vaccine
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) from the first vaccination up to 6 months after the second vaccination
Measured: From the first vaccination up to 6 months after the second vaccination
Secondary outcomes (4)
Observe the humoral immunity of LYB004 vaccine
The geometric mean concentration (GMC in mIU/ml), geometric mean fold rise (GMFR), and serum seroconversion rate (%) of gE antibodies at 14 and 30 days after each vaccination; the geometric mean titer (GMT in 1:X), GMFR, and serum seroconversion rate (%) of VZV antibodies at 14 and 30 days after each vaccination
Measured: At 14 and 30 days after each vaccination
Observe the cellular immunity of LYB004 vaccine
The frequency and the cell mediated immunity (CMI) response rate (%) of gE-specific CD4^2+ and CD8^2+ T cells (expressing at least 2 different activation markers: IFN-γ, IL-2, TNF-α, and CD40L) per 10^6 CD4 and CD8 T cells at 30 days after the second vaccination
Measured: At 30 days after the second vaccination
Observe the persistence of humoral immunity of LYB004 vaccine
The GMC in mIU/ml, GMFR, and serum seroconversion rate (%) of gE antibodies at 6 months after the second vaccination; the GMT in 1:X, GMFR, and serum seroconversion rate (%) of VZV antibodies at 6 months after the second vaccination
Measured: At 6 months after full vaccination
Observe the persistence of cellular immunity of LYB004 vaccine
The frequency and the CMI response rate (%) of gE-specific CD4^2+ and CD8^2+T cells per 10^6 CD4 and CD8 T cells at 6 months after the second vaccination
Measured: At 6 months after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start27 Mar 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Christina Chang, M.D, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335849
- Sponsor's protocol ID
- LYB004-CT-AUS-101
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Observer-blinded, Positive-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years
- ClinicalTrials.gov ID
- NCT06335849
- Acronym / sponsor ID
- LYB004-CT-AUS-101
- Conditions
- Herpes Zoster
- Keywords
- Recombinant Zoster Vaccine, Glycoprotein E, Varicella-Zoster Virus, Herpes zoster, Shingles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd.
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Mar 2024 (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.
This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years.
Detailed description
A randomized, observer-blinded, positive-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB004 in adults 50 to 70 years of age. A total of 48 healthy subjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:1) to receive LYB004 or SHINGRIX. Two dose levels of LYB004 will be provided, low dose 25 μg and high dose 50 μg. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 (LYB004 25µg) | Experimental | Biological: LYB004 25µgSubjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. |
| Treatment 2 (LYB004 50µg) | Experimental | Biological: LYB004 50µgSubjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. |
| Treatment 3 (SHINGRIX) | Active comparator | Biological: SHINGRIXSubjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A male or female aged 50 to 70 years inclusive at screening.
- Written informed consent obtained from the subject before any assessment is performed.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol. (e.g., complete the diary cards, and complete follow-up visits).
- Subjects must have a Body Mass Index (BMI) between ≥18.0 and ≤35.0 kg/m^2 at screening.
- Female subjects who are not pregnant or lactating. Female subjects with childbearing potential and their partners should use highly effective, medically accepted double-barrier contraception and will not have pregnancy and fertility plan until study completion.
Key exclusion criteria (10 listed)
- Tympanic temperature > 37.5°C at screening.
- History of HZ.
- Previous vaccination against HZ or varicella. Planned administration of VZV or HZ vaccination during the study (including an investigational or non-registered vaccine), except for the investigational vaccine.
- Received a live attenuated vaccine within 28 days before vaccination or received other vaccines within 14 days before vaccination.
- Received any immunoglobulins or blood/plasma products within 3 months 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 |
|---|---|---|
| LYB004 25µgSubjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. | Biological | Treatment 1 (LYB004 25µg) |
| LYB004 50µgSubjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. | Biological | Treatment 2 (LYB004 50µg) |
| SHINGRIXSubjects will be enrolled and stratified by age (50-59 years and 60-70 years in a 1:1 ratio) and randomized (2:2:1) to receive 25 μg LYB004, 50 μg LYB004 or SHINGRIX. The two-dose immunization schedule will be adopted, that is, LYB004 or SHINGRIX will be intramuscularly injected on Day 0 and Day 60. | Biological | Treatment 3 (SHINGRIX) |
Primary outcome
Evaluate the reactogenicity of LYB004 vaccine
Time frame: Within 30 minutes after each vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination
Evaluate the safety and reactogenicity of LYB004 vaccine
Time frame: Within 0-7 days after each vaccination
The incidence and severity of any solicited local and systemic AEs and unsolicited AEs within 0-7 days after each vaccination
Evaluate the safety of LYB004 vaccine
Time frame: Within 30 days after each vaccination
The incidence and severity of any AEs within 30 days after each vaccination
Evaluate the safety and tolerability in laboratory tests of LYB004 vaccine
Time frame: 3 days, 14 days after each vaccination and 90 days after the first vaccination
The occurrence of clinically significant laboratory abnormalities 3 days, 14 days after each vaccination and 90 days after the first vaccination
Evaluate the SAEs and AESIs of LYB004 vaccine
Time frame: From the first vaccination up to 6 months after the second vaccination
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) from the first vaccination up to 6 months after the second vaccination
4 secondary outcomes
Observe the humoral immunity of LYB004 vaccine
Time frame: At 14 and 30 days after each vaccination
Observe the cellular immunity of LYB004 vaccine
Time frame: At 30 days after the second vaccination
Observe the persistence of humoral immunity of LYB004 vaccine
Time frame: At 6 months after full vaccination
Observe the persistence of cellular immunity of LYB004 vaccine
Time frame: At 6 months after full vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- 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.
Christina Chang, M.D principal investigator
Nucleus Network Pty Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYB004 25µg, LYB004 50µg and SHINGRIX in people with Herpes Zoster, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in Australia.
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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. 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 Australia. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evaluate the reactogenicity of LYB004 vaccine (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?
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 13 Mar 2025.