Herpes ZosterPhase 3NCT07293065
A Phase III Clinical Trial to Evaluate Long-Term Protective Efficacy of Recombinant Zoster Vaccine (CHO Cell)
A Phase 3 study testing Recombinant Zoster Vaccine (CHO Cell) in people with Herpes Zoster, run by MAXVAX Biotechnology Limited Liability Company at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Recombinant Zoster Vaccine (CHO Cell)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12,000 participants
- Where
- 4 sitesChina
- Study dates
- 15 Dec 2025to 31 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Yunnan Center For Disease Control and Prevention
Kunming, Yunnan, 650022
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, 050021
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, 430070
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, 450016
About this study
Official 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
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
- Being tested
- Recombinant Zoster Vaccine (CHO Cell), NaCl solution Placebo
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 PlaceboBiological
0.5 mL per dose, containing 4.5 mg sodium chloride. Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Group | Experimental | Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule Receives: Biological: Recombinant Zoster Vaccine (CHO Cell) |
| Placebo Group | Placebo comparator | Subjects will receive NaCl solution placebo according to a 0, 2-month schedule Receives: Biological: NaCl solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after the last vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293065
- Sponsor's protocol ID
- MKKCT-100-005
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No