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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose vaccine group in adults aged 30 to 49 years | Experimental | Participants aged 30 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
|
| High dose vaccine group in adults aged 30 to 49 years | Experimental | Participants aged 30 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
|
| Placebo group in adults aged 30 to 49 years | Placebo Comparator | Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). |
|
| Low dose vaccine group in adults aged 50 years and older | Experimental | Participants aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
|
| High dose vaccine group in adults aged 50 years and older |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose Recombinant Herpes Zoster Vaccine (CHO cells) | Biological | 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentration (GMC) of anti-gE antibody | Measured by ELISA. | 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. | 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. | 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). | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of Serious Adverse Events | Incidence of Serious Adverse Events (SAEs) from the first vaccination to 12 months after the last vaccination. | From the first vaccination to 12 months after the last vaccination |
| Potential Immune-Mediated Diseases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang | Henan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanjin Center for Disease Control and Prevention | Xinxiang | Henan | 453200 | China |
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| Experimental |
Participants aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM). |
|
| Shingrix® group in adults aged 50 years and older | Active Comparator | Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM). |
|
| Placebo group in adults aged 50 years and older | Placebo Comparator | Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). |
|
| High dose Recombinant Herpes Zoster Vaccine (CHO cells) | Biological | 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105. |
|
| Positive control | Biological | 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B. |
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| Placebo | Biological | 0.5 mL per dose, containing 4.5 mg sodium chloride. |
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| Month 1 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\ | 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. | 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. | 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. | 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. | Within 30 days after each vaccination |
Incidence of Potential Immune-Mediated Diseases (pIMDs) from the first vaccination to 12 months after the last vaccination. |
| From the first vaccination to 12 months after the last vaccination |
| Geometric mean concentration (GMC) of anti-VZV antibody | measured by ELISA. | 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. | 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. | 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). | 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). | Month 1 after the last vaccination |
| Geometric mean concentration (GMC) of anti-gE antibody | measured by ELISA. | 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. | At 6, 12 and 24 months after the last vaccination |
| Geometric mean concentration (GMC) of anti-VZV antibody | measured by ELISA. | 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. | 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. | 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\ | At 6, 12 and 24 months after the last vaccination |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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