Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
- 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.
- Short title
- Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
- Official title
- A Phase II, Single Center, Randomized, Blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-03-31
- First posted
- 2023-05-12
- Registry last updated
- 2024-11-20
- Primary completion date
- 2024-12-28
- Start date
- 2023-05-07
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- 1:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- MAXVAX Biotechnology Limited Liability Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05856084
- ClinicalTrials.gov ID
- NCT05856084
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Geometric mean concentration (GMC) of anti-gE antibody
Timeframe: Month 1 after the last vaccination
Measured by ELISA.
Seropositivity rate of anti-gE antibody
Timeframe: 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.
Seroresponse rate of anti-gE antibody
Timeframe: 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
Timeframe: Month 1 after the last vaccination
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Four-fold increase rate of anti-gE antibody concentration
Timeframe: Month 1 after the last vaccination
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Cell-Mediated Immunity (CMI) response
Timeframe: 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.
Vaccine Response Rate (VRR)
Timeframe: 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.
The incidence and severity of adverse events
Timeframe: Within 30 minutes after each vaccination
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.
The incidence and severity of adverse events
Timeframe: Within 7 days after each vaccination
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.
The incidence and severity of adverse events
Timeframe: Day 8 to 30 after each vaccination
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.
The incidence and severity of adverse events
Timeframe: 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.
The incidence of Serious Adverse Events
Timeframe: 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.
Potential Immune-Mediated Diseases
Timeframe: 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 concentration (GMC) of anti-VZV antibody
Timeframe: Month 1 after the last vaccination
measured by ELISA.
Seropositivity rate of anti-VZV antibody
Timeframe: 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.
Seroresponse rate of anti-VZV antibody
Timeframe: 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-VZV antibody
Timeframe: Month 1 after the last vaccination
The antibody concentration at month 1 after the last vaccination compared with that at baseline (Day 0).
Four-fold increase rate of anti-VZV antibody
Timeframe: 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-gE antibody
Timeframe: At 6, 12 and 24 months after the last vaccination
measured by ELISA.
Seropositivity rate of anti-gE antibody
Timeframe: 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.
Geometric mean concentration (GMC) of anti-VZV antibody
Timeframe: At 6, 12 and 24 months after the last vaccination
measured by ELISA.
Seropositivity rate of anti-VZV antibody
Timeframe: 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
Timeframe: 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)
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 30 Years
- Healthy volunteers
- Yes
- 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.
- Yanjin Center for Disease Control and PreventionXinxiang, China
Related records
Drugs (2)
Collaborators (1)
- Henan Center for Disease Control and Prevention
Lead sponsors (1)
Conditions (1)
- Herpes zoster Primary condition