A Phase 3 interventional study of Recombinant Zoster Vaccine (CHO Cell) in Herpes Zoster, sponsored by MAXVAX Biotechnology Limited Liability Company. Completed at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by MAXVAX Biotechnology Limited Liability Company · Phase 3, Interventional, and Prevention
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.
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.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
This study's enrollment of 1,200 is above the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →MAXVAX Biotechnology Limited Liability Company is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule
Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule
Biological: Recombinant Zoster Vaccine (CHO Cell)
Subjects will receive Recombinant Zoster Vaccine (CHO cell) according to a 0, 2-month schedule
Biological: 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
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.
Time frame: At Month 0 and Month 3.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3).
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in May 2025, 4 months.
Of 33 industry-sponsored phase 3 interventional studies under Herpes Zoster, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's 4 months is below that.
Counting every sponsor, half of 40 studies reached it within 16 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CHO cell
MAXVAX Biotechnology Limited Liability Company