The purposes of the study are to evaluate the safety and tolerability of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 18 years and older, and to preliminarily explore immunogenicity.
The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 18 to 49 years and 50 years and older, with progression from low dose level to high dose level and younger age group to the older age group based on assessment of safety and tolerability. The younger cohort (aged 18 to 49 years) will consist of 60 subjects, 30 per dose level, and these 30 subjects will be randomized into three subgroups, including vaccine group, adjuvant group and normal saline group, with randomization ratio of 2:2:1. The older cohort (aged 50 years and older) will consist of 72 subjects, 36 per dose level, and these 36 subjects will be randomized into four subgroups, including vaccine group, adjuvant group, Shingrix® group and normal saline group, with randomization ratio of 2:2:1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
132
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
0.5 mL per dose, containing low dose MA105 adjuvant.
Yanjin District Center for Disease Control and Prevention
Xinxiang, Henan, China
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 30 minutes after each vaccination.
The incidence and severity of adverse events
Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 7 days after each vaccination.
The incidence and severity of adverse events
Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Day 8 to 30 after each vaccination.
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 30 days after each vaccination.
Incidence of abnormal and clinically significant laboratory test results
Laboratory test includes hematology, blood biochemistry and urine analysis.
Time frame: Day 4 after each vaccination .
Incidence of Serious Adverse Event
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0.5 mL per dose, containing high dose MA105 adjuvant.
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
0.5 mL per dose, containing 4.5 mg sodium chloride.
Incidence of Serious Adverse Event (SAE) from the first vaccination to 12 months after full vaccination.
Time frame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Potential Immune Mediated Disorder
Incidence of Potential Immune Mediated Disorder (pIMD) from the first vaccination to 12 months after full vaccination.
Time frame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Prior to each vaccination (Day 0, Day 60).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was \<Cut-off value at baseline.
Time frame: Prior to the second vaccination (Day 60).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was \<Cut-off value at baseline.
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was \<Cut-off value at baseline.
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Prior to each vaccination (Day 0, Day 60).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Time frame: Prior to the second vaccination (Day 60).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at 1 month after each vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after each vaccination (Day 30, Day 90)
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Time frame: Prior to the second vaccination (Day 60).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at month 1 after each vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time frame: Prior to the first vaccination (Day 0).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time frame: Month 1 after the second vaccination (Day 90).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time frame: Month 6, 12 after the second vaccination (Day 240, Day 420).
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells \<Cut-off value at baseline.
Time frame: Prior to the first vaccination (Day 0).
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells \<Cut-off value at baseline.
Time frame: Month 1 after the second vaccination (Day 90).
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells \<Cut-off value at baseline.
Time frame: Month 6, 12 after the second vaccination (Day 240, Day 420)