Active, not recruiting
Phase 2
Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above
Condition(s) studied
Herpes Zoster
Investigational drug(s) / intervention(s)
Low dose Recombinant Herpes Zoster Vaccine (CHO cells)High dose Recombinant Herpes Zoster Vaccine (CHO cells)Positive controlPlacebo
Low dose Recombinant Herpes Zoster Vaccine (CHO cells): 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
High dose Recombinant Herpes Zoster Vaccine (CHO cells): 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
Positive control: 0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
Placebo: 0.5 mL per dose, containing 4.5 mg sodium chloride.
Study 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.
Eligibility
Inclusion Criteria:
1. Permanent residents aged 30 years and above;
2. Subjects voluntarily agree to participate in the study and signed an informed consent;
3. Be able to participate in all scheduled visits and comply with the protocol requirements.
Exclusion Criteria:
1. Axillary temperature\>37.0℃;
2. History of herpes zoster within 5 years before vaccination;
3. Prior vaccination with chickenpox vaccine or herpes zoster vaccine;
4. Female participant who is pregnant ( urine pregnancy test was positive) or breastfeeding, or has pregnancy plans within 1 year after the last vaccination;
5. Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior to vaccination;
6. Receipt of immunoglobulin or intravenous immunoglobulin within 3 months before vaccination;
7. Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination;
8. A known allergy to any components of the study vaccine (especially allergic to aminoglycoside antibiotics), or history of severe allergy to any previous vaccination;
9. 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;
10. Asplenia or functional asplenia, or splenectomy caused by any condition;
11. 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;
12. 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;
13. Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severe liver or kidney disease; or diabetes with complication;
14. History of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications;
15. Abnormal blood pressure during physical examination before vaccination (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg);
16. Current or history of alcohol and/or drug abuse;
17. Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.
Primary outcome measure(s)
- Geometric mean concentration (GMC) of anti-gE antibody — Month 1 after the last vaccination
Measured by ELISA.
- 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.
- 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).
- 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).
- 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.
- 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.
- The incidence and severity of adverse events — 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 — 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 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Yanjin Center for Disease Control and Prevention |
Xinxiang |
Henan |
|
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