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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Herpes Zoster
• Intervention / Treatment: Biological: NaCl solution Placebo; Biological: Recombinant Zoster Vaccine (CHO Cell)

• Study Type: Interventional
• Enrollment (Estimated): 12000
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050021
      • Hebei Provincial Center for Disease Control and Prevention
  • Henan
    • Zhengzhou, Henan, China, 450016
      • Henan Center for Diseases Control and Prevention
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Hubei Provincial Center for Disease Control and Prevention
  • Yunnan
    • Kunming, Yunnan, China, 650022
      • Yunnan Center For Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants in the MKKCT-100-003 study who have completed two doses of the investigational vaccine;
2. Males or females able to provide legal identity certificate;
3. Participants voluntarily agree to participate in the study, and sign the informed consent form;
4. 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:

1. 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;
2. Participants with a history of herpes zoster;
3. 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);
4. Participants who are currently participating in or plan to participate in other clinical trials during the study;
5. Significant underlying diseases or any other condition that, in the opinion of the investigator, may prevent completion of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Group; Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule	Biological: Recombinant Zoster Vaccine (CHO Cell); 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with MA105. Intramuscular injection
Placebo Comparator: Placebo Group; Subjects will receive NaCl solution placebo according to a 0, 2-month schedule	Biological: NaCl solution Placebo; 0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 13~36 months after the last vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	At 30 days~36 months after the last vaccination.
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.	30 days to 36 months, 13 to 36 months, and 30 days after the last vaccination.
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.	30 days after the last vaccination.

Collaborators and Investigators

• Sponsor: MAXVAX Biotechnology Limited Liability Company

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster
• Other Study ID Numbers: MKKCT-100-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No