A Phase 1 interventional study of Low Dose Recombinant Herpes Zoster Vaccine (CHO cells) and High Dose Recombinant Herpes Zoster Vaccine (CHO cells) in Herpes Zoster, sponsored by MAXVAX Biotechnology Limited Liability Company. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by MAXVAX Biotechnology Limited Liability Company · Phase 1, Interventional, and Prevention
The purposes of the study are to evaluate the safety and tolerability of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 18 years and older, and to preliminarily explore immunogenicity.
The clinical trial will be a single-center, randomized, blind, controlled study in which two dose levels of vaccine will be tested in healthy adults aged 18 to 49 years and 50 years and older, with progression from low dose level to high dose level and younger age group to the older age group based on assessment of safety and tolerability. The younger cohort (aged 18 to 49 years) will consist of 60 subjects, 30 per dose level, and these 30 subjects will be randomized into three subgroups, including vaccine group, adjuvant group and normal saline group, with randomization ratio of 2:2:1. The older cohort (aged 50 years and older) will consist of 72 subjects, 36 per dose level, and these 36 subjects will be randomized into four subgroups, including vaccine group, adjuvant group, Shingrix® group and normal saline group, with randomization ratio of 2:2:1:1.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
This study's enrollment of 132 is below 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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects aged 18 to 49 years will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)
Subjects aged 18 to 49 years will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Low dose adjuvant
Subjects aged 18 to 49 years will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: High Dose Recombinant Herpes Zoster Vaccine (CHO cells)
Subjects aged 18 to 49 years will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: High dose adjuvant
Subjects aged 18 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Placebo
Subjects aged 50 years and older will be vaccinated with 2 doses of low dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Low Dose Recombinant Herpes Zoster Vaccine (CHO cells)
Subjects aged 50 years and older will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Low dose adjuvant
Subjects aged 50 years and older will be vaccinated with 2 doses of high dose recombinant herpes zoster vaccine (CHO cells) on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: High Dose Recombinant Herpes Zoster Vaccine (CHO cells)
Subjects aged 50 years and older will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: High dose adjuvant
Subjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Positive control
Subjects aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Biological: Placebo
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
0.5 mL per dose, containing low dose MA105 adjuvant.
0.5 mL per dose, containing high dose MA105 adjuvant.
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
Also known as: Shingrix®
0.5 mL per dose, containing 4.5 mg sodium chloride.
Also known as: Saline for injection
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 minutes after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 30 minutes after each vaccination.
The incidence and severity of adverse events
Incidence and severity of adverse events within 7 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 7 days after each vaccination.
The incidence and severity of adverse events
Incidence and severity of adverse events during Day 8 to 30 after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Day 8 to 30 after each vaccination.
The incidence and severity of adverse events
Incidence and severity of adverse events within 30 days after each vaccination. The severity of solicited and unsolicited adverse events will be graded from grade 1 to grade 4, other adverse events will be graded from grade 1 to grade 5.
Time frame: Within 30 days after each vaccination.
Incidence of abnormal and clinically significant laboratory test results
Laboratory test includes hematology, blood biochemistry and urine analysis.
Time frame: Day 4 after each vaccination .
Incidence of Serious Adverse Event
Incidence of Serious Adverse Event (SAE) from the first vaccination to 12 months after full vaccination.
Time frame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Potential Immune Mediated Disorder
Incidence of Potential Immune Mediated Disorder (pIMD) from the first vaccination to 12 months after full vaccination.
Time frame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Prior to each vaccination (Day 0, Day 60).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Measured by ELISA.
Time frame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was \<Cut-off value at baseline.
Time frame: Prior to the second vaccination (Day 60).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was \<Cut-off value at baseline.
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Seroconversion rate of anti-gE antibody and anti-VZV antibody
Seroconversion is defined as a ≥4 fold rise in antibody concentration compared with baseline for those antibody concentration was ≥Cut-off value at baseline; or a ≥4 fold Cut-off value in antibody concentration compared with baseline for those antibody concentration was \<Cut-off value at baseline.
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Prior to each vaccination (Day 0, Day 60).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Positive rate of anti-gE antibody and anti-VZV antibody
Positive rate is defined as percentage of subjects with antibody concentration ≥Cut-off value.
Time frame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Time frame: Prior to the second vaccination (Day 60).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at 1 month after each vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after each vaccination (Day 30, Day 90)
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration prior to the second vaccination compared with that at baseline (Day 0).
Time frame: Prior to the second vaccination (Day 60).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at Day 14 after each vaccination compared with that at baseline (Day 0).
Time frame: Day 14 after each vaccination (Day 14, Day 74).
Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
The antibody concentration at month 1 after each vaccination compared with that at baseline (Day 0).
Time frame: Month 1 after each vaccination (Day 30, Day 90).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time frame: Prior to the first vaccination (Day 0).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time frame: Month 1 after the second vaccination (Day 90).
Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
The analysis focused on CD4+ T-cells expressing at least 1 immunological activation marker among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L).
Time frame: Month 6, 12 after the second vaccination (Day 240, Day 420).
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells \<Cut-off value at baseline.
Time frame: Prior to the first vaccination (Day 0).
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells \<Cut-off value at baseline.
Time frame: Month 1 after the second vaccination (Day 90).
Cellular immune response
Cellular immune response is defined as the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥2 fold increase compared with baseline for those the frequency of gE-specific CD4+ T-cells ≥Cut-off value at baseline; or the frequency of gE-specific CD4+ T-cells (expressing at least 1 Immunological activation marker) ≥Cut-off value for those the frequency of gE-specific CD4+ T-cells \<Cut-off value at baseline.
Time frame: Month 6, 12 after the second vaccination (Day 240, Day 420)
Plan to share: No
No publications or documents are linked to this record.
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 drugs tested here: CHO Cells · Adjuvant
MAXVAX Biotechnology Limited Liability Company