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

3. listopadu 2026 aktualizováno: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

500

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Yi Mo, Principal Investigator
  • Telefonní číslo: +86-13788686968
  • E-mail: moyi0415@qq.com

Studijní místa

  • Čína
    • Nanning
      • Guangxi, Nanning, Čína, 530022
        • Nábor
        • Guangxi Zhuang Autonomous Region People's Hospital
        • Kontakt:
          • Huijuan Li
          • Telefonní číslo: 18877168857
      • Guangxi, Nanning, Čína, 530028
        • Nábor
        • Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Study participants must meet all of the following inclusion criteria:

    1. 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:

    1. 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Phase I clinical trial - low-dose adjuvanted vaccine group

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.
Biologický: Low-dose adjuvanted recombinant zoster vaccine

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.
Experimentální: Phase I clinical trial - High-dose adjuvanted vaccine group

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.
Biologický: High-dose adjuvanted recombinant zoster vaccine (0 and 30 days schedule)

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.
Komparátor placeba: Phase I clinical trial - Low-dose adjuvant placebo group

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.
Biologický: Low-dose adjuvant placebo

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.
Komparátor placeba: Phase I clinical trial - High-dose adjuvant placebo group

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.
Biologický: High-dose adjuvant placebo

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.
Experimentální: Phase II clinical trial - adjuvanted vaccine group 1

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.
Biologický: Low-dose adjuvanted recombinant zoster vaccine

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.
Experimentální: Phase II clinical trial - adjuvanted vaccine group 2

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.
Biologický: High-dose adjuvanted recombinant zoster vaccine (0 and 60 days schedule)

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.
Komparátor placeba: Phase II clinical trial - positive control group (GlaxoSmithKline Biologicals SA)

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.
Biologický: Zoster Vaccine Recombinant, Adjuvanted

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Safety Endpoints(1):Occurrence of all AEs
Časové okno: 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.
within 30 days after each dose of vaccination
Safety Endpoints(2):Occurrence of all SAEs
Časové okno: 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).
from the first dose up to 12 months after completion of the full vaccination series
Safety Endpoints(3):Occurrence of all pIMDs
Časové okno: 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).
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
Časové okno: 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
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
Časové okno: 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
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
Časové okno: 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
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.
Časové okno: 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
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)
Časové okno: 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.
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
Časové okno: 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.
Pre-vaccination (Baseline), Day 4 after the first dose
Percentage of Participants With Clinically Significant Hematology Laboratory Abnormalities
Časové okno: 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.
Pre-vaccination (Baseline), Day 4 after the first dose
Percentage of Participants With Clinically Significant Urinalysis Laboratory Abnormalities
Časové okno: 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.
Pre-vaccination (Baseline), Day 4 after the first dose
Percentage of Participants With Clinically Significant Coagulation Laboratory Abnormalities
Časové okno: 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.
Pre-vaccination (Baseline), Day 4 after the first dose

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

10. listopadu 2026

Primární dokončení (Odhadovaný)

23. května 2029

Dokončení studie (Odhadovaný)

23. května 2029

Termíny zápisu do studia

První předloženo

21. října 2026

První předloženo, které splnilo kritéria kontroly kvality

3. listopadu 2026

První zveřejněno (Aktuální)

5. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • LKM-2025-HZV02

Informace o lécích a zařízeních, studijní dokumenty

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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