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Herpes ZosterPhase 1/2NCT07920172

Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)

A Phase 1/2 study testing Low-dose adjuvanted recombinant zoster vaccine, High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule) and High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule) in people with Herpes Zoster, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
Low-dose adjuvanted recombinant zoster vaccine, High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule) and High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
2 sitesChina
Study dates
10 Nov 2026to 23 May 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 informed consent 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:
  • <!-- -->
  • Pre-vaccination laboratory test parameters with clinically meaningful abnormalities as specified in the protocol (Phase I only); (2) History of varicella vaccination or herpes zoster vaccination (including marketed vaccines and investigational vaccines); (3) Current herpes zoster infection or history of herpes zoster; (4) Close contact with varicella/herpes zoster patients within 30 days prior to the first dose; (5) Use of blood products or immunoglobulins within 3 months prior to the first dose, or planned use of blood products or immunoglobulins during the study period; (6) Use of other investigational or unregistered products (drugs or vaccines) within 1 month prior to the first dose, or planned participation in other clinical trials during this study; (7) Immunodeficiency or impairment, including but not limited to: primary immunodeficiency diseases, active autoimmune diseases (e.g., systemic lupus erythematosus, active rheumatoid arthritis, severe psoriasis, etc.), HIV infection, asplenia or functional asplenia, lymphoma, leukemia, etc.; (8) Receipt of immunosuppressive agents or other immunomodulators within 3 months prior to the first dose or planned use during the study period, such as long-term systemic corticosteroid therapy (oral/intravenous prednisone or equivalent for a total duration of more than 2 weeks), steroid pulse therapy (inhaled or topical use is not restricted), chemotherapy, radiotherapy, anti-rejection therapy after organ transplantation, etc.; (9) Allergy to any component of the investigational vaccine, or history of severe reactions to any vaccine or drug, e.g., urticaria, eczema, dyspnea, angioedema, etc.; (10) Presence of major diseases or major potential diseases that may interfere with or preclude completion of the study (e.g., severe cardiovascular and cerebrovascular diseases: cor pulmonale, pulmonary edema, uncontrolled hypertension [systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg], myocardial infarction/stroke within the past 12 months, NYHA Class III/IV; severe hepatic or renal diseases: e.g., decompensated cirrhosis, renal insufficiency on dialysis or imminently requiring dialysis, etc.; diabetes with severe complications; history of major organ transplantation; active malignancy, etc.); (11) Thrombocytopenia or other coagulation disorders (which may constitute contraindications to intramuscular injection); (12) Pregnant or lactating women; (13) Inability to ensure effective contraception from the time of signing informed consent to 3 months after completion of full vaccination series (effective contraceptive measures include: oral/injectable/implantable contraceptives, intrauterine devices, barrier methods (male/female condoms) with spermicides, partner surgical sterilization, or complete abstinence); (14) History of severe or active psychiatric and neurological diseases, including but not limited to: uncontrolled epilepsy, progressive neuropathy, history of Guillain-Barré syndrome, demyelinating diseases, post-encephalitis/myelitis with significant functional impairment, etc.; (15) Any other condition judged by the investigator as potentially affecting study evaluation, making the participant unsuitable for participation in this study.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Mo, Principal Investigator contact

+86-13788686968

moyi0415@qq.com

China2 sites, 2 recruiting

  • Guangxi Zhuang Autonomous Region People's Hospital

    Guangxi, Nanning, 530022

    Huijuan Li, 18877168857

    Recruiting

  • Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

    Guangxi, Nanning, 530028

    Yi Mo, 13788686968, moyi0415@qq.com

    Recruiting

Other trials in China

About this study

Official title: Randomized, Multi-cohort, Controlled Phase I/II Clinical Trials Evaluating the Safety, Tolerability and Immunogenicity of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cell) for Vaccination in Healthy Subjects Aged 40 Years and Above

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.

Read the detailed description

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.

Conditions
Herpes Zoster
Being tested
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
Keywords
prevention
Medical subject headings
Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose adjuvanted recombinant zoster vaccineBiological

    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.

  • High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule)Biological

    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.

  • High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule)Biological

    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.

  • Low-dose adjuvant placeboBiological

    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.

  • High-dose adjuvant placeboBiological

    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.

  • Zoster Vaccine Recombinant, AdjuvantedBiological

    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.

Study groups in NCT07920172
Study groupRoleWhat they receive
Phase I clinical trial - low-dose adjuvanted vaccine groupExperimentalSubjects 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.
Receives: Biological: Low-dose adjuvanted recombinant zoster vaccine
Phase I clinical trial - High-dose adjuvanted vaccine groupExperimentalSubjects 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.
Receives: Biological: High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule)
Phase I clinical trial - Low-dose adjuvant placebo groupPlacebo comparatorSubjects 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.
Receives: Biological: Low-dose adjuvant placebo
Phase I clinical trial - High-dose adjuvant placebo groupPlacebo comparatorSubjects 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.
Receives: Biological: High-dose adjuvant placebo
Phase II clinical trial - adjuvanted vaccine group 1ExperimentalSubjects 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.
Receives: Biological: Low-dose adjuvanted recombinant zoster vaccine
Phase II clinical trial - adjuvanted vaccine group 2ExperimentalSubjects 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.
Receives: Biological: High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule)
Phase II clinical trial - positive control group (GlaxoSmithKline Biologicals SA)Placebo comparatorSubjects 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.
Receives: Biological: Zoster Vaccine Recombinant, Adjuvanted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within 30 days after each dose of vaccination

  2. 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).

    Measured: from the first dose up to 12 months after completion of the full vaccination series

  3. 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).

    Measured: from the first dose up to 12 months after completion of the full vaccination series

  4. 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

    Measured: at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series

  5. 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

    Measured: at 30 days, 6 months, and 12 months after completion of full vaccination series

  6. 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

    Measured: at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series

  7. 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

    Measured: at 30 days after completion of full vaccination series

  8. 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.

    Measured: at pre-first dose, 30 days after completion of full vaccination series, and 6 and 12 months after completion of full vaccination series

  9. 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.

    Measured: Pre-vaccination (Baseline), Day 4 after the first dose

  10. 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.

    Measured: Pre-vaccination (Baseline), Day 4 after the first dose

  11. 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.

    Measured: Pre-vaccination (Baseline), Day 4 after the first dose

  12. 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.

    Measured: Pre-vaccination (Baseline), Day 4 after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start10 Nov 2026 (estimated)
  3. Primary completion23 May 2029 (estimated)
  4. Study completion23 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920172
Sponsor's protocol ID
LKM-2025-HZV02
Status last verified
Nov 2026
First submitted
21 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Low-dose adjuvanted recombinant zoster vaccine, High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule) and High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule) in people with Herpes Zoster, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Mo, Principal Investigator (+86-13788686968, moyi0415@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Endpoints(1):Occurrence of all AEs (time frame: within 30 days after each dose of vaccination). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07920172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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