Herpes ZosterPhase 3NCT06654700
Phase III Clinical Trial of Lot-to-lot Consistency of Recombinant Herpes 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 1 site in China.
Trial summary
To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine (CHO cell) produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0, 2 month schedule. 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?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 9 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- A male or female permanent resident aged 40 years and older at enrollment, with valid identity;
- Subjects voluntarily agree to participate in the study and signed an informed consent;
- Be able to understand clinical trials, participate in all scheduled visits and comply with the protocol requirements(e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
- Women of childbearing potential plan to avoid pregnancy and are willing to use effective contraception(e.g. oral contraceptive pills, injectable progestogen, percutaneous contraceptive patches, implants of levonorgestrel, intrauterine device, female and male sterilization or abstinence) within 12 months after the last vaccination, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable.
Who cannot join
- Axillary temperature > 37.0°C on the day of vaccination or acute illness;
- Current or history of herpes zoster;
- Previous vaccination against varicella or herpes zoster (either registered product or participation in a previous vaccine study);
- Pregnant (urine pregnancy test was positive) or lactating female;
- Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
- Receipt of immunoglobulin or intravenous immunoglobulin during 3 months before vaccination, or planned receipt 1 month post the last vaccination;
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- Acute diseases(such as acute upper respiratory tract infection with fever, cough, sore throat) or acute exacerbation of chronic disease within 3 days before vaccination;
- Receipt of antipyretic, analgesic and allergy drugs within 3 days before vaccination, except enteric-coated aspirin for cardiovascular diseases prevention;
- A known allergy to any components of the study vaccine, or history of severe allergy (e.g. Anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, severe urticaria) to any previous vaccination;
- Allergy to aminoglycoside antibiotics;
- History of convulsions, epilepsy, congenital brain dysplasia, mental illness or family history, or history of brain nerve tissue damage due to other severe neurological disorders(e.g. brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, chemical drug poisoning);
- Asplenia or functional asplenia, or splenectomy caused by any condition;
- Primary or secondary impairment of immune function, diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease or other autoimmune diseases;
- Receipt of Immunosuppressive therapy(such as long-term use of systemic glucocorticoid ≥14 days, ≥20mg/day prednisone or equivalent dose) or long-acting immune-modifying drugs(e.g. Infliximab) during the period starting 6 months before vaccination or planned administration 1 month after the last vaccination, but topical steroids(e.g. ointment, eye drops, inhalants, nasal sprays) that do not exceed the dosage recommended in the instructions or have any systemic signs are acceptable;
- Patients with severe chronic diseases, including but not limited to severe cardiovascular diseases (pulmonary heart disease, pulmonary edema), severe liver and kidney diseases, and diabetes mellitus with complications;
- History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications;
- Abnormal and uncontrolled blood pressure during physical examination before vaccination (for subjects aged 40-59: systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg; for subjects aged ≥60, systolic pressure ≥ 150 mmHg and/or diastolic pressure ≥ 100 mmHg);
- History of drug abuse (narcotic drugs, psychotropic drugs);
- Patients with previous or current malignant tumors (except papillary thyroid cancer);
- Receipt of investigational or unapproved products (drugs or vaccines) within 6 months before vaccination; or planned participation in another clinical study during the study period;
- Any condition that, in the opinion the investigator, makes subjects ineligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, 450016
About this study
Official title: A Randomized, Double-blind Phase III Clinical Trial to Evaluate the Lot-to-lot Consistency of Three Consecutive Batches of Recombinant Herpes Zoster Vaccine (CHO Cell) Produced at a Commercial Scale in Subjects Aged 40 Years and Older.
To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine (CHO cell) produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0, 2 month schedule.
Read the detailed description
A total of 1200 subjects aged 40 years and older were randomly assigned in a 1:1:1 ratio to three commercial-scale batches (batch 1, batch 2, Batch 3) , with 400 subjects in each group. To demonstrate lot-to-lot consistency in terms of anti-gE antibody GMC between three production lots of the HZ vaccine one month after the second dose.
- Conditions
- Herpes Zoster
- Being tested
- Recombinant Zoster Vaccine (CHO Cell)
- 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
| Study group | Role | What they receive |
|---|---|---|
| Herpes Zoster vaccine（Commercial-scale batch 1 group） | Experimental | Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule |
| Herpes Zoster vaccine（Commercial-scale batch 2 groups） | Experimental | Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule Receives: Biological: Recombinant Zoster Vaccine (CHO Cell) |
| Herpes Zoster vaccine（Commercial-scale batch 3 groups） | Experimental | Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule Receives: Biological: Recombinant Zoster Vaccine (CHO Cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The geometric mean concentration (GMC) of anti-gE antibodies one month after full vaccination.
Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter.
Measured: At Month 0 and Month 3.
Secondary outcomes (6)
The seroconversion rate of anti-gE antibodies one month after full vaccination.
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Measured: At Month 3.
The incidence, severity, and vaccine-related association of solicited local adverse events (AEs) within 7 days after each dose of vaccination.
This typically refers to the documentation and assessment of local adverse events (such as pain and swelling at the injection site) that occur within 7 days after vaccination in clinical studies or vaccination programs. This includes the frequency of occurrence, severity (usually categorized as mild, moderate, and severe), and the investigator's assessment of the association between these events and vaccination.
Measured: During the 7 days (Days 0-6) after each vaccine dose.
The incidence, severity, and relevance to vaccination of solicited general adverse events (AEs) within 7 days after each dose of vaccination.
This typically refers to the documentation and assessment of general adverse events that occur within the 7-day observation period after each vaccination dose, including the frequency of occurrence, severity (such as mild, moderate, and severe), and the investigator's assessment of the association between these events and the vaccination.
Measured: During the 7 days (Days 0-6) after each vaccine dose.
The incidence, severity, and relevance to vaccination of unsolicited adverse events (AEs) within 30 days after each vaccine dose.
This typically refers to the documentation and assessment of unexpected adverse events that occur within the 30-day observation period after each vaccine dose, including the frequency of occurrence, severity (such as mild, moderate, and severe), and the investigator's assessment of the association between these events and vaccination.
Measured: During 30 days (Days 0-29) after each vaccination.
The incidence of serious adverse events (SAEs) from the first dose of vaccination to one month after the final dose.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From first vaccination up to 30 days post last vaccination (Month 0-Month 3).
The incidence of potential immune-mediated diseases (pIMDs) from the first dose of vaccination to one month after the final dose.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From first vaccination up to 30 days post last vaccination (Month 0-Month 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start16 Dec 2024
- Primary completion9 May 2025
- Study completion9 May 2025
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Master, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654700
- Sponsor's protocol ID
- MKKCT-100-004
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Phase III Clinical Trial to Evaluate the Lot-to-lot Consistency of Three Consecutive Batches of Recombinant Herpes Zoster Vaccine (CHO Cell) Produced at a Commercial Scale in Subjects Aged 40 Years and Older.
- ClinicalTrials.gov ID
- NCT06654700
- Acronym / sponsor ID
- MKKCT-100-004
- Conditions
- Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- MAXVAX Biotechnology Limited Liability CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine (CHO cell) produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0, 2 month schedule.
Detailed description
A total of 1200 subjects aged 40 years and older were randomly assigned in a 1:1:1 ratio to three commercial-scale batches (batch 1, batch 2, Batch 3) , with 400 subjects in each group. To demonstrate lot-to-lot consistency in terms of anti-gE antibody GMC between three production lots of the HZ vaccine one month after the second dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Herpes Zoster vaccine（Commercial-scale batch 1 group） | Experimental | –Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule |
| Herpes Zoster vaccine（Commercial-scale batch 2 groups） | Experimental | Biological: Recombinant Zoster Vaccine (CHO Cell)Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule |
| Herpes Zoster vaccine（Commercial-scale batch 3 groups） | Experimental | Biological: Recombinant Zoster Vaccine (CHO Cell)Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A male or female permanent resident aged 40 years and older at enrollment, with valid identity;
- Subjects voluntarily agree to participate in the study and signed an informed consent;
- Be able to understand clinical trials, participate in all scheduled visits and comply with the protocol requirements(e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
- Women of childbearing potential plan to avoid pregnancy and are willing to use effective contraception(e.g. oral contraceptive pills, injectable progestogen, percutaneous contraceptive patches, implants of levonorgestrel, intrauterine device, female and male sterilization or abstinence) within 12 months after the last vaccination, and the uses of the rhythm method alone, withdrawal alone, and emergency contraception, are not acceptable.
Key exclusion criteria (21 listed)
- Axillary temperature > 37.0°C on the day of vaccination or acute illness;
- Current or history of herpes zoster;
- Previous vaccination against varicella or herpes zoster (either registered product or participation in a previous vaccine study);
- Pregnant (urine pregnancy test was positive) or lactating female;
- Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Herpes Zoster vaccine（Commercial-scale batch 2 groups）, Herpes Zoster vaccine（Commercial-scale batch 3 groups） |
Primary outcome
The geometric mean concentration (GMC) of anti-gE antibodies one month after full vaccination.
Time frame: At Month 0 and Month 3.
Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter.
6 secondary outcomes
The seroconversion rate of anti-gE antibodies one month after full vaccination.
Time frame: At Month 3.
The incidence, severity, and vaccine-related association of solicited local adverse events (AEs) within 7 days after each dose of vaccination.
Time frame: During the 7 days (Days 0-6) after each vaccine dose.
The incidence, severity, and relevance to vaccination of solicited general adverse events (AEs) within 7 days after each dose of vaccination.
Time frame: During the 7 days (Days 0-6) after each vaccine dose.
The incidence, severity, and relevance to vaccination of unsolicited adverse events (AEs) within 30 days after each vaccine dose.
Time frame: During 30 days (Days 0-29) after each vaccination.
The incidence of serious adverse events (SAEs) from the first dose of vaccination to one month after the final dose.
Time frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3).
The incidence of potential immune-mediated diseases (pIMDs) from the first dose of vaccination to one month after the final dose.
Time frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanxia Wang, Master principal investigator
Henan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Zoster Vaccine (CHO Cell) in people with Herpes Zoster, run by MAXVAX Biotechnology Limited Liability Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The geometric mean concentration (GMC) of anti-gE antibodies one month after full vaccination. (time frame: At Month 0 and Month 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.