Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
NCT07920172, Phase 1, Phase 2, Recruiting, Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells) | ClinicalTrials.gov |
| NCT number | NCT07920172 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. | ClinicalTrials.gov |
| Conditions | Herpes Zoster | ClinicalTrials.gov |
| Interventions | Low-dose adjuvanted recombinant zoster vaccine, High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule), High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule), Low-dose adjuvant placebo, High-dose adjuvant placebo, Zoster Vaccine Recombinant, Adjuvanted | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety Endpoints(1):Occurrence of all AEs | within 30 days after each dose of vaccination | Occurrence of all adverse events (AEs) within 30 days after each dose of vaccination (number of episodes, number of cases, incidence rate, severity, and relationship to the investigational vaccine): 1. Occurrence of AEs within 30 minutes after each dose of vaccination; 2. Occurrence of solicited AEs within 0-14 days after each dose of vaccination; 3. Occurrence of unsolicited AEs within 30 days after each dose of vaccination. | ClinicalTrials.gov |
| Primary | Safety Endpoints(2):Occurrence of all SAEs | from the first dose up to 12 months after completion of the full vaccination series | Occurrence of all SAEs from the first dose up to 12 months after completion of the full vaccination series (number of cases, number of episodes, incidence rate, and relationship to the investigational vaccine). | ClinicalTrials.gov |
| Primary | Safety Endpoints(3):Occurrence of all pIMDs | from the first dose up to 12 months after completion of the full vaccination series | Occurrence of all potential immune-mediated disorders (pIMDs) from the first dose up to 12 months after completion of the full vaccination series (number of episodes, number of cases, incidence rate, severity, and relationship to the investigational vaccine). | ClinicalTrials.gov |
| Primary | Immunogenicity Endpoints (1): GMTs of VZV gE antibody and VZV antibody | at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series | Humoral Immunity: (1) GMTs of VZV gE antibody and VZV antibody at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series | ClinicalTrials.gov |
| Primary | Immunogenicity Endpoints (2): GMIs of VZV gE antibody and VZV antibody | at 30 days, 6 months, and 12 months after completion of full vaccination series | Humoral Immunity: (2) GMIs of VZV gE antibody and VZV antibody at 30 days, 6 months, and 12 months after completion of full vaccination series | ClinicalTrials.gov |
| Primary | Immunogenicity Endpoints (3): Seropositivity rates of VZV gE antibody and VZV antibody | at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series | Humoral Immunity: (3) Seropositivity rates of VZV gE antibody and VZV antibody at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series | ClinicalTrials.gov |
| Primary | Immunogenicity Endpoints (4): Seroconversion rates of VZV gE antibody and VZV antibody. | at 30 days after completion of full vaccination series | Humoral Immunity: (4) Seroconversion rates of VZV gE antibody and VZV antibody at 30 days after completion of full vaccination series | ClinicalTrials.gov |
| Primary | Immunogenicity Endpoints (5): Detection frequency of CD4²⁺ T cells secreting at least two gE-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L, IL-17A) | at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series | Cellular immunity: Detection frequency of CD4²⁺ T cells secreting at least two gE-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L, IL-17A) at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series. | ClinicalTrials.gov |
| Primary | Percentage of Participants With Clinically Significant Serum Chemistry Laboratory Abnormalities | Pre-vaccination (Baseline), Day 4 after the first dose | Proportion of participants with clinically meaningful abnormalities in serum chemistry parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), fasting glucose (GLU), creatinine (CRE), assessed according to CTCAE v5.0 criteria, compared with pre-vaccination baseline. | ClinicalTrials.gov |
| Primary | Percentage of Participants With Clinically Significant Hematology Laboratory Abnormalities | Pre-vaccination (Baseline), Day 4 after the first dose | Proportion of participants with clinically meaningful abnormalities in hematology parameters, including hemoglobin (HGB), red blood cell count (RBC), white blood cell count (WBC), platelet count (PLT), assessed according to CTCAE v5.0 criteria, compared with pre-vaccination baseline. | ClinicalTrials.gov |
| Primary | Percentage of Participants With Clinically Significant Urinalysis Laboratory Abnormalities | Pre-vaccination (Baseline), Day 4 after the first dose | Proportion of participants with clinically meaningful abnormalities in urinalysis parameters, including urine protein (PRO), urine red blood cell (RBC), assessed according to CTCAE v5.0 criteria, compared with pre-vaccination baseline. | ClinicalTrials.gov |
| Primary | Percentage of Participants With Clinically Significant Coagulation Laboratory Abnormalities | Pre-vaccination (Baseline), Day 4 after the first dose | Proportion of participants with clinically meaningful abnormalities in coagulation parameters, including prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), international normalized ratio (INR), assessed according to CTCAE v5.0 criteria, compared with pre-vaccination baseline. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)