A Phase 1/2 interventional study of Low-dose adjuvanted recombinant zoster vaccine and High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule) in Herpes Zoster, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 1/2, Interventional, and Prevention
A seamless Phase I/II trial evaluating the immunogenicity and safety of a recombinant herpes zoster ZFA01 adjuvanted vaccine (CHO cell) in healthy adults aged ≥40 years. Phase I (n=100): randomized, blinded, placebo-controlled, age/dose escalation across 4 cohorts. Phase II (n=400): randomized, open-label, active-controlled, with 1:1 or 1:1:1 allocation to two experimental groups and a positive control group across three age strata.
This trial adopts a seamless Phase I/II trial design, conducted in two stages: Phase I and Phase II. Phase I is an age/dose escalation stage, employing a randomized, blinded, placebo-controlled design to observe the safety of the vaccine. Phase II further expands the trial population to investigate the safety and immunogenicity of different immunization schedules, employing a randomized, open-label, active-controlled design with blinded assessment during the serological testing phase. The primary objective is to evaluate the immunogenicity and safety of the recombinant herpes zoster ZFA01 adjuvanted vaccine (CHO cell) in healthy populations aged 40 years and older.
Phase I evaluates the tolerability of different adjuvant doses in trial participants, enrolling a total of 100 participants in two age groups: 40-59 years and 60 years and older. Participants are enrolled in an age-escalation sequence (40-59 years → 60 years and older) and a dose-escalation sequence (from low-dose adjuvanted vaccine to high-dose adjuvanted vaccine), assigned to 4 cohorts at a 4:1 ratio.
Phase II aims to demonstrate the immunogenicity and safety of the vaccine in the target population, enrolling a total of 400 trial participants. Among them, 100 participants aged 40-49 years are randomized at a 1:1 ratio to experimental group 1 and experimental group 2; 210 participants aged 50-69 years and 90 participants aged 70 years and older are randomized at a 1:1:1 ratio to experimental group 1, experimental group 2, and the positive control group.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
This study's planned enrollment of 500 is above the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Study participants must meet all of the following inclusion criteria:
Aged 40 years or older, permanent residents; (2) Voluntarily participate in this study and sign the form; (3) Able to comply with the requirements of the clinical study protocol.
Exclusion Criteria:Study participants with any of the following conditions shall not be enrolled in the study:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive 2 doses of the recombinant herpes zoster adjuvanted vaccine at a 30-day interval. Main components: 50 μg of varicella-zoster virus glycoprotein E (gE) per 0.5 mL, and 375 μg of ZFA01 adjuvant per 0.5 mL.
Biological: Low-dose adjuvanted recombinant zoster vaccine
Subjects will receive 2 doses of the recombinant herpes zoster adjuvanted vaccine at a 30-day interval. Main components: 50 μg of varicella-zoster virus glycoprotein E (gE) per 0.5 mL, and 750 μg of ZFA01 adjuvant per 0.5 mL.
Biological: High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule)
Subjects will receive 2 doses of the recombinant herpes zoster adjuvanted vaccine at a 30-day interval. Main component: 375 μg of ZFA01 adjuvant per 0.5 mL.
Biological: Low-dose adjuvant placebo
Subjects will receive 2 doses of the recombinant herpes zoster adjuvanted vaccine at a 30-day interval. Main component: 750 μg of ZFA01 adjuvant per 0.5 mL.
Biological: High-dose adjuvant placebo
Subjects will receive 2 doses of the recombinant herpes zoster adjuvanted vaccine at a 30-day interval. Main components: 50 μg of varicella-zoster virus glycoprotein E (gE) per 0.5 mL, and 750 μg of ZFA01 adjuvant per 0.5 mL.
Biological: Low-dose adjuvanted recombinant zoster vaccine
Subjects will receive 2 doses of the recombinant herpes zoster adjuvanted vaccine at a 60-day interval. Main components: 50 μg of varicella-zoster virus glycoprotein E (gE) per 0.5 mL, and 750 μg of ZFA01 adjuvant per 0.5 mL.
Biological: High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule)
Subjects will receive 2 doses of the recombinant herpes zoster adjuvanted vaccine at a 60-day interval. Main component: 50 μg of varicella-zoster virus glycoprotein E (gE) per 0.5 mL. Main components: 50 μg of Quillaja saponaria saponin QS-21 per 0.5 mL, 50 μg of 3-O-desacyl-4'-monophosphoryl lipid A per 0.5 mL, 1 mg of dioleoylphosphatidylcholine per 0.5 mL, and 0.25 mg of cholesterol per 0.5 mL.
Biological: Zoster Vaccine Recombinant, Adjuvanted
0.5 mL per dose, containing 50 μg varicella-zoster virus glycoprotein E (gE) plus 375 μg adjuvant, intramuscular administration, 2 doses at Day 0 and Day 30.
0.5 mL per dose, containing 50 μg varicella-zoster virus glycoprotein E (gE) plus 750 μg adjuvant, intramuscular administration, 2 doses at Day 0 and Day 30.
0.5 mL per dose, containing 50 μg varicella-zoster virus glycoprotein E (gE) plus 750 μg adjuvant, intramuscular administration, 2 doses at Day 0 and Day 60.
0.5 mL per dose, containing 375 μg adjuvant only, no varicella-zoster virus glycoprotein E (gE), intramuscular administration, 2 doses at Day 0 and Day 30.
0.5 mL per dose, containing 750 μg adjuvant only, no varicella-zoster virus glycoprotein E (gE), intramuscular administration, 2 doses at Day 0 and Day 30.
0.5 mL per dose, containing 50 μg varicella-zoster virus glycoprotein E (gE), adjuvanted with AS01B, intramuscular administration, 2 doses at Day 0 and Day 60.
Safety Endpoints(1):Occurrence of all AEs
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.
Time frame: within 30 days after each dose of vaccination
Safety Endpoints(2):Occurrence of all SAEs
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).
Time frame: from the first dose up to 12 months after completion of the full vaccination series
Safety Endpoints(3):Occurrence of all pIMDs
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).
Time frame: from the first dose up to 12 months after completion of the full vaccination series
Immunogenicity Endpoints (1): GMTs of VZV gE antibody and VZV antibody
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
Time frame: at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series
Immunogenicity Endpoints (2): GMIs of VZV gE antibody and VZV antibody
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
Time frame: at 30 days, 6 months, and 12 months after completion of full vaccination series
Immunogenicity Endpoints (3): Seropositivity rates of VZV gE antibody and VZV antibody
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
Time frame: at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series
Immunogenicity Endpoints (4): Seroconversion rates of VZV gE antibody and VZV antibody.
Humoral Immunity: (4) Seroconversion rates of VZV gE antibody and VZV antibody at 30 days after completion of full vaccination series
Time frame: at 30 days after completion of full vaccination series
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)
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.
Time frame: at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series
Percentage of Participants With Clinically Significant Serum Chemistry Laboratory Abnormalities
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.
Time frame: Pre-vaccination (Baseline), Day 4 after the first dose
Percentage of Participants With Clinically Significant Hematology Laboratory Abnormalities
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.
Time frame: Pre-vaccination (Baseline), Day 4 after the first dose
Percentage of Participants With Clinically Significant Urinalysis Laboratory Abnormalities
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.
Time frame: Pre-vaccination (Baseline), Day 4 after the first dose
Percentage of Participants With Clinically Significant Coagulation Laboratory Abnormalities
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.
Time frame: Pre-vaccination (Baseline), Day 4 after the first dose
Start is estimated for Nov 2026; primary completion for May 2029, 30 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. →