Herpes ZosterPhase 3NCT06447779
Efficacy, Safety and Immunogenicity Study of Recombinant Zoster Vaccine(CHO Cell) in Adults Aged 40 Years and Older
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 efficacy, safety and immunogenicity of Recombinant Zoster Vaccine (CHO Cell) with 2 doses at 2-month interval in adults aged 40 years and older. 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
- 25,000 participants
- Where
- 4 sitesChina
- Study dates
- 13 Jul 2024to Nov 2027
- 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
- A male or famale 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 aviod pregnancy and are willing to use effcetive 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℃;
- 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 to 1 month post the last vaccination;
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- Acute diseases 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, encephalopathy (e.g. congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning), mental illness and family history, and other serious neurological diseases;
- 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 (e.g. long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose) during 6 months before vaccination to 1 minth post the last vaccination, but inhaled, nasal spray, intra-articular, eyedrops, ointment and other topical steroids are acceptable;
- Receipt of long-acting immune-modifying drugs (e.g. Infliximab) within 6 months before vaccination or during the study period;
- Severe chronic disease, including but not limited to, severe cardiovascular disease(e.g. Pulmonary heart disease, Pulmonary Edema), severe liver or kidney disease, or diabetes with complication;
- History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications;
- Abnormal and uncontrlled 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);
- Current skin infections, in the opinion of the investigator, might interfere with the efficacy evaluation;
- Current or history of malignant tumors, except papillary thyroid carcinoma;
- Receipt of investigational products (drugs or vaccines) within 6 months before vaccination;
- Planned participation in another clinical study during the study period;
- Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.
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, Randomized, Double-Blinded, Placebo-Controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of Recombinant Zoster Vaccine (CHO Cell) in Adults Aged 40 Years and Above
The purpose of the sutdy is to evaluate efficacy, safety and immunogenicity of Recombinant Zoster Vaccine (CHO Cell) with 2 doses at 2-month interval in adults aged 40 years and older.
Read the detailed description
A total of 25000 adults aged 40 years and older will be enrolled, stratified into 40-49, 50-59, 60-69 and ≥70 years of age. All subjects will randomly receive investigational vaccine or placebo at a ratio of 1:1. Efficacy and safety will be assessed in all subjects, while immunogenicity will be assessed in a subset of 1250 subjests in a selected trial site.
- 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.
Incidence of confirmed Herpes Zoster(HZ) Cases per person years in subjects aged 40 years and older
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: 30 days after the last vaccination
Secondary outcomes (14)
Incidence of confirmed Herpes Zoster(HZ) Cases per person years in different age group.
All subjects will be stratified into 40-49 years, 50-59 years, 60-69 years and ≥70 years of age.
Measured: 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.
PHN of any severity was defined as 0 and greater on the Zoster Brief Pain Inventory(ZBPI) questionnaire, while severe PHN rated as 3 and greater on the ZBPI questionnaire.
Measured: 30 days after the last vaccination
Geometric Mean Concentration(GMC) of anti-gE antibody and anti-VZV antibody in immunogenicity subset
Measured by ELISA
Measured: At 1, 12, 24 and 36 months after the last vaccination
Seropositivity rate of anti-gE antibody and anti-VZV antibody in immunogenicity subset
The seropositivity rate is defined as the percentage of subjects whose antibody concentration is greater than or equal to the cut-off value.
Measured: At 1, 12, 24 and 36 months after the last vaccination
Seroresponse rate of anti-gE antibody and anti-VZV antibody in immunogenicity subset
The seroresponse rate is defined as the percentage of subjects who have at least a: 4-fold increase in the antibody concentration as compared to the pre vaccination antibody concentration, for subjects who are seropositive at baseline, OR, 4-fold increase in the antibody concentration as compared to the antibody concentration cut-off value for seropositivity, for subjects who are seronegative at baseline.
Measured: 30 days after the last vaccination
Geometric Mean Fold Rise (GMFR) of anti-gE antibody and anti-VZV antibody in immunogenicity subset
The antibody concentration at evaluted time points compared with that at baseline.
Measured: At 1, 12, 24 and 36 months after the last vaccination
Four-fold increase rate of anti-gE antibody and anti-VZV antibody in immunogenicity subset
The antibody concentration 30 days after the last vaccination compared with that at baseline.
Measured: 30 days after the last vaccination
Cell-Mediated Immunity (CMI) response
CMI response is defined as the frequency of CD4+ T cells producing at least 2 activation markers (IFN-γ, IL-2, TNF-α and/or CD40L) upon in vitro stimulation by gE peptide pools.
Measured: 30 days after the last vaccination
Vaccine Response Rate (VRR)
VRR is defined as the percentage of subjects with at least a 2-fold increase as compared to the Cut-off, for subjects with pre-vaccination T-cell frequencies<Cut-off, OR, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies for subjects with pre-vaccination T-cell frequencies ≥Cut-off.
Measured: 30 days after the last vaccination
Number of Participants With solicited local symptoms
Assessed solicited local symptoms were pain, Induration, swelling, redness, pruritus, rash, and cellulitis.
Measured: Within 7 days after each vaccination
Number of Participants With solicited general symptoms.
Assessed solicited general symptoms were fever [defined as axillary equal to or above 37.3 degrees Celsius (°C)], diarrhoea, anorexia, vomiting, nausea, abdominal pain, myalgia, arthralgia, headache, syncope, new convulsions, cough, pruritus (non-vaccination site), skin and mucous membrane abnormalities, acute allergic reactions, fatigue, pain (non-vaccination site), chills.
Measured: Within 7 days after each dose
Number of Participants With unsolicited adverse events
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During 30 days after each vaccination
Number of Participants With Serious Adverse Events
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From the day of first vaccination up to 12 months after last vaccination
Number of Participants With potential Immune Mediated Disorders
pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: From the day of first vaccination up to 12 months after last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start13 Jul 2024
- Primary completion29 Mar 2026
- Study completionNov 2027 (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
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang Yanxia, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447779
- Sponsor's protocol ID
- MKKCT-100-003
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No