Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
- Conditions
- Herpes Zoster
- Interventions
- Biological: High dose Recombinant Herpes Zoster Vaccine (CHO cells)Biological: Low dose Recombinant Herpes Zoster Vaccine (CHO cells)Biological: Positive controlBiological: Placebo
- Registration Number
- NCT05856084
- Lead Sponsor
- MAXVAX Biotechnology Limited Liability Company
- Brief Summary
The purposes of the study are to evaluate the immunogenicity and safety of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 30 years and older.
- Detailed Description
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 30 to 49 years and 50 years and older. A total of 924 participants will be enrolled, including 396 participants aged 30 to 49 years and 528 participants aged 50 years and older. Participants aged 30 to 49 years will be randomized into three subgroups (low dose vaccine group, high dose vaccine group and placebo group) in a 1:1:1 ratio. Participants aged 50 years and older will be randomized into four subgroups (low dose vaccine group, high dose vaccine group, Shingrix® group and placebo group) in a 1:1:1:1 ratio.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 924
- Permanent residents aged 30 years and above;
- Subjects voluntarily agree to participate in the study and signed an informed consent;
- Be able to participate in all scheduled visits and comply with the protocol requirements.
- Axillary temperature>37.0℃;
- History of herpes zoster within 5 years before vaccination;
- Prior vaccination with chickenpox vaccine or herpes zoster vaccine;
- Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination;
- Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
- Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination;
- Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
- A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination;
- History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection disease, nerve tissue damage caused by chemical drug poisoning, etc.) or mental illness and family history;
- Asplenia or functional asplenia, or splenectomy caused by any condition;
- Primary or secondary impairment of immune function or diagnosed congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;
- Receipt of immunosuppressive therapy within 3 months before vaccination (such as long-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/day prednisone or equivalent dose), but inhaled, intra-articular and topical steroids are acceptable;
- Severe cardiovascular disease(eg. 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 blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg);
- Current or history of alcohol and/or drug abuse;
- Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose vaccine group in adults aged 30 to 49 years High dose Recombinant Herpes Zoster Vaccine (CHO cells) Participants aged 30 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). Low dose vaccine group in adults aged 30 to 49 years Low dose Recombinant Herpes Zoster Vaccine (CHO cells) Participants aged 30 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). Shingrix® group in adults aged 50 years and older Positive control Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM). Placebo group in adults aged 30 to 49 years Placebo Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). Placebo group in adults aged 50 years and older Placebo Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM). Low dose vaccine group in adults aged 50 years and older Low dose Recombinant Herpes Zoster Vaccine (CHO cells) Participants 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). High dose vaccine group in adults aged 50 years and older High dose Recombinant Herpes Zoster Vaccine (CHO cells) Participants 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).
- Primary Outcome Measures
Name Time Method The incidence and severity of adverse events Within 30 days after each vaccination 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.
Seroresponse rate of anti-gE antibody Month 1 after the last vaccination 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.
Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration Month 1 after the last vaccination The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Vaccine Response Rate (VRR) Month 1 after the last vaccination VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies\<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
Geometric mean concentration (GMC) of anti-gE antibody Month 1 after the last vaccination Measured by ELISA.
Four-fold increase rate of anti-gE antibody concentration Month 1 after the last vaccination The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Seropositivity rate of anti-gE antibody Month 1 after the last vaccination The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Cell-Mediated Immunity (CMI) response Month 1 after the last vaccination 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.
- Secondary Outcome Measures
Name Time Method Seropositivity rate of anti-VZV antibody At 6, 12 and 24 months after the last vaccination The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Seropositivity rate of anti-gE antibody At 6, 12 and 24 months after the last vaccination The seropositivity rate is defined as the percentage of seropositive subjects. A seronegative subject is a subject whose antibody concentration is below the cut-off value. A seropositive subject is a subject whose antibody concentration is greater than or equal to the cut-off value.
Cell-Mediated Immunity (CMI) response At 6, 12 and 24 months after the last vaccination 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.
Vaccine Response Rate (VRR) At 6, 12 and 24 months after the last vaccination VRR is defined as the percentage of participants with T-cell frequencies are ≥Cut-off value, for participants with T-cell frequencies\<Cut-off at baseline, OR, at least a 2-fold increase as compared to baseline for participants with T-cell frequencies ≥Cut-off value at baseline.
The incidence of Serious Adverse Events From the first vaccination to 12 months after the last vaccination Incidence of Serious Adverse Events (SAEs) from the first vaccination to 12 months after the last vaccination.
Four-fold increase rate of anti-VZV antibody Month 1 after the last vaccination The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Geometric mean concentration (GMC) of anti-VZV antibody At 6, 12 and 24 months after the last vaccination measured by ELISA.
Geometric mean concentration (GMC) of anti-gE antibody At 6, 12 and 24 months after the last vaccination measured by ELISA.
Potential Immune-Mediated Diseases From the first vaccination to 12 months after the last vaccination Incidence of Potential Immune-Mediated Diseases (pIMDs) from the first vaccination to 12 months after the last vaccination.
Geometric Mean Fold Rise (GMFR) of anti-VZV antibody Month 1 after the last vaccination The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Seroresponse rate of anti-VZV antibody Month 1 after the last vaccination 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.
Trial Locations
- Locations (1)
Yanjin Center for Disease Control and Prevention
🇨🇳Xinxiang, Henan, China