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NCT Number: NCT07293065

A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)

The purpose of the sutdy is to evaluate the protective efficacy of Recombinant Herpes Zoster Vaccine (CHO Cell) (hereinafter referred to as "the investigational vaccine") in preventing herpes zoster at 13-36 months after complete immunization with the 0- and 2-month immunization schedule in individuals aged 40 years and older.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in the MKKCT-100-003 study who have completed two doses of the investigational vaccine;
  • Males or females able to provide legal identity certificate;
  • Participants voluntarily agree to participate in the study, and sign the informed consent form;
  • Able to understand the study procedures and participate in all scheduled follow-up visits, and able to comply with the protocol requirements (such as cooperating in filling out questionnaires/scales, and being regularly contacted during the study for evaluation, etc.).

Exclusion criteria

  • Participants who plan to use any products (drugs, vaccines, or medical devices) other than the investigational product for the prevention of VZV infection before signing the informed consent form or during the study period;
  • Participants with a history of herpes zoster;
  • Participants with any confirmed or suspected immunosuppressive or immunodeficiency condition caused by diseases (e.g., malignant tumors, human immunodeficiency virus infections, etc.) or immunosuppressive/cytotoxic treatments (e.g., medications used during cancer chemotherapy, organ transplantation, or treatment of autoimmune diseases);
  • Participants who are currently participating in or plan to participate in other clinical trials during the study;
  • Significant underlying diseases or any other condition that, in the opinion of the investigator, may prevent completion of the trial.

Treatment and study plan

Recombinant Zoster Vaccine (CHO Cell)

Biological

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection

NaCl solution Placebo

Biological

0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection

Primary outcomes

  1. The person-year incidence of confirmed herpes zoster cases among individuals aged 40 years and older, 13 to 36 months after completing the full vaccination course with the investigational vaccine according to the 0- and 2-month immunization schedule.

    Time frame: At 13~36 months after the last vaccination

    A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the Endpoint Adjudication Committee (EAC), consisting of physicians with HZ expertise.

Secondary outcomes

  1. The person-year incidence of confirmed herpes zoster cases among individuals aged 40 years and older: from 30 days to 36 months after completing the full vaccination course, and the annual person-year incidence from 30 days after the full vaccination.

    Time frame: At 30 days~36 months after the last vaccination.

  2. The person-year incidence rate of confirmed Herpes Zoster (HZ) cases during the periods of 30 days to 36 months, 13 to 36 months, and annually after 30 days post full-course immunization, in populations of different age groups.

    Time frame: 30 days to 36 months, 13 to 36 months, and 30 days after the last vaccination.

  3. Incidence of any and severe Postherpetic Neuralgia (PHN) cases per person years in subjects aged 40 years and older, 40-49years , 50-59 years , 60-69 years and ≥70 years , with confirmed HZ.

    Time frame: 30 days after the last vaccination.

Sponsors and collaborators

Lead sponsor

MAXVAX Biotechnology Limited Liability Company

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Long-Term Protective Efficacy of Recombinant Herpes Zoster Vaccine (CHO Cell) in Adults Aged 40 Years and Above

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 18, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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