Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06851832 | Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older | PHASE1 | ACTIVE NOT_RECRUITING | 960 | — | — | Feb 16, 2025 | Sep 16, 2028 | Mar 31, 2026 | 1 | China |
Detected using intracellular cytokine staining (ICS) by flow cytometry
Detected using enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| Recombinant zoster Vaccine (CHO cell) (low adjuvant) | EXPERIMENTAL | It is used for vaccination of experimental vaccine group A subjects in phase I and II clinical trials |
| Recombinant zoster Vaccine (CHO cell) | EXPERIMENTAL | It is used for vaccination of experimental vaccine group B subjects of phase I clinical trial , experimental vaccine group B1 and B2 subjects of phase II clinical trial |
| Zoster Vaccine, Live | ACTIVE_COMPARATOR | It is used for vaccination of positive control group A1 and A2 subjects in phase Ⅱ clinical trial |
| Recombinant Zoster Vaccine (CHO cell) (Adjuvant control) | PLACEBO_COMPARATOR | It is used for vaccination of adjuvant control group subjects in phase Ⅰ clinical trial |
| normal saline | PLACEBO_COMPARATOR | Used in phase Ⅰ clinical trial; To maintain blinding, positive control group A1 and positive control group A2 received placebo on day 0 (for phase II clinical trial). |
| Name | Type | Description |
|---|---|---|
| Recombinant zoster vaccine(CHO cell)(low adjuvant) | BIOLOGICAL | The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 50 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose. |
| Recombinant Zoster Vaccine (CHO cell) | BIOLOGICAL | The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. Vaccination Schedule 1: A total of two doses will be given, with the second dose administered 30 days after the first dose. Vaccination Schedule 2: A total of two doses will be given, with the second dose administered 60 days after the first dose \[only applicable to the Phase II Experimental Vaccine Group B2\]. |
| Zoster Vaccine, Live | BIOLOGICAL | The dosage for each administration is 0.5 mL, containing not less than 4.3 lg PFU of varicella-zoster live virus, administered subcutaneously at the attachment site of the lower edge of the deltoid muscle on the outer side of the upper arm. A total of one dose will be given. To maintain blinding, the positive control group A1 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 30. The positive control group A2 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 60. |
| Recombinant Zoster Vaccine (CHO cell) (Adjuvant control) | BIOLOGICAL | The dosage for each administration is 0.5 mL, containing 0.25 mL of MF59 and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose. |
| Normal Saline | BIOLOGICAL | The dosage for each administration is 0.5 mL, containing 0.5 mL of NaCl solution, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose (applicable to Phase I clinical trial). To maintain blinding, subjects in the positive control A1 and positive control A2 groups will receive a placebo on Day 0 (applicable to Phase II clinical trial). |
Inclusion Criteria: * Male or female participants aged 40 years or older at the time of enrollment. * Voluntarily agrees to participate in the trial, fully understands, and signs the informed consent form. * Able to attend all scheduled follow-ups and comply with the clinical trial protocol require...