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

NCT07293065 | Active Not Recruiting Phase 3

• 1 other identifier: MKKCT-100-005
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Herpes Zoster

Outcome Measures

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.

  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 Outcomes (3)

• 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.

Study Arms (2)

Vaccine Group

EXPERIMENTAL

Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule

Biological: Recombinant Zoster Vaccine (CHO Cell)

Placebo Group

PLACEBO COMPARATOR

Subjects will receive NaCl solution placebo according to a 0, 2-month schedule

Biological: NaCl solution Placebo

Interventions

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

Vaccine Group

NaCl solution Placebo BIOLOGICAL

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

Placebo Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MAXVAX Biotechnology Limited Liability Company: lead

Study Sites (4)

Hebei Provincial Center for Disease Control and Prevention

Shijiazhuang, Hebei, 050021, China

Location

Henan Center for Diseases Control and Prevention

Zhengzhou, Henan, 450016, China

Location

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, 430070, China

Location

Yunnan Center For Disease Control and Prevention

Kunming, Yunnan, 650022, China

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 18, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)