The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.
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 30 to 49 years and 50 years and older. A total of 924 participants will be enrolled, including 396 participants aged 30 to 49 years and 528 participants aged 50 years and older. Participants aged 30 to 49 years will be randomized into three subgroups (low dose vaccine group, high dose vaccine group and placebo group) in a 1:1:1 ratio. Participants aged 50 years and older will be randomized into four subgroups (low dose vaccine group, high dose vaccine group, Shingrix® group and placebo group) in a 1:1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
924
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 a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
Yanjin Center for Disease Control and Prevention
Xinxiang, Henan, China
Geometric mean concentration (GMC) of anti-gE antibody
Measured by ELISA.
Time frame: Month 1 after the last vaccination
Seropositivity rate of anti-gE antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time frame: Month 1 after the last vaccination
Seroresponse rate of anti-gE antibody
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Time frame: Month 1 after the last vaccination
Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after the last vaccination
Four-fold increase rate of anti-gE antibody concentration
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after the last vaccination
Cell-Mediated Immunity (CMI) response
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL-2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Time frame: Month 1 after the last vaccination
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0.5 mL per dose, containing 4.5 mg sodium chloride.
Vaccine Response Rate (VRR)
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies\<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
Time frame: Month 1 after the last vaccination
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
The incidence of Serious Adverse Events
Incidence of Serious Adverse Events (SAEs) from the first vaccination to 12 months after the last vaccination.
Time frame: From the first vaccination to 12 months after the last vaccination
Potential Immune-Mediated Diseases
Incidence of Potential Immune-Mediated Diseases (pIMDs) from the first vaccination to 12 months after the last vaccination.
Time frame: From the first vaccination to 12 months after the last vaccination
Geometric mean concentration (GMC) of anti-VZV antibody
measured by ELISA.
Time frame: Month 1 after the last vaccination
Seropositivity rate of anti-VZV antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time frame: Month 1 after the last vaccination
Seroresponse rate of anti-VZV antibody
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Time frame: Month 1 after the last vaccination
Geometric Mean Fold Rise (GMFR) of anti-VZV antibody
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after the last vaccination
Four-fold increase rate of anti-VZV antibody
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after the last vaccination
Geometric mean concentration (GMC) of anti-gE antibody
measured by ELISA.
Time frame: At 6, 12 and 24 months after the last vaccination
Seropositivity rate of anti-gE antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time frame: At 6, 12 and 24 months after the last vaccination
Geometric mean concentration (GMC) of anti-VZV antibody
measured by ELISA.
Time frame: At 6, 12 and 24 months after the last vaccination
Seropositivity rate of anti-VZV antibody
The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Time frame: At 6, 12 and 24 months after the last vaccination
Cell-Mediated Immunity (CMI) response
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL 2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Time frame: At 6, 12 and 24 months after the last vaccination
Vaccine Response Rate (VRR)
VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies\<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
Time frame: At 6, 12 and 24 months after the last vaccination