Long-term Efficacy of Recombinant Zoster Vaccine (CHO Cell) Study

MAXVAX Biotechnology

Status and phase: Not yet enrolling; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: Recombinant Zoster Vaccine (CHO Cell); Biological: NaCl solution Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07293065

MKKCT-100-005

Details and patient eligibility

About

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.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12,000 participants in 2 patient groups, including a placebo group

Vaccine Group

Experimental group

Description:

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

Treatment:

Biological: Recombinant Zoster Vaccine (CHO Cell)

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Biological: NaCl solution Placebo