Long-term Efficacy of Recombinant Zoster Vaccine (CHO Cell) Study
NCT ID: NCT07293065
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
12000 participants
INTERVENTIONAL
2025-12-19
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vaccine Group
Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule
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 Group
Subjects will receive NaCl solution placebo according to a 0, 2-month schedule
NaCl solution Placebo
0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection
Interventions
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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
NaCl solution Placebo
0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
ALL
Yes
Sponsors
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MAXVAX Biotechnology Limited Liability Company
INDUSTRY
Responsible Party
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Locations
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Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Yunnan Center For Disease Control and Prevention
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Zhiwei Wu, Master
Role: primary
Yanxia Wang, Master
Role: primary
Beifang Yang, Doctor
Role: primary
Yan Zheng, Master
Role: primary
Other Identifiers
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MKKCT-100-005
Identifier Type: -
Identifier Source: org_study_id