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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
48
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.
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.
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.
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Evaluate the reactogenicity of LYB004 vaccine
The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the first vaccination up to 6 months after the second vaccination
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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 6 months after full vaccination