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| Name | Class |
|---|---|
| Yantai Patronus Biotech Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYB004 25µg | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the reactogenicity of LYB004 vaccine | The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination | 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 | 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 | 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 | 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 | From the first vaccination up to 6 months after the second vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 14 and 30 days after each vaccination |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Chang, M.D | Nucleus Network Pty Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| LYB004 50µg | Biological | 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. |
|
| SHINGRIX | Biological | 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. |
|
| 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 | 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 | 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 | At 6 months after full vaccination |
| D007239 | Infections |