Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above
NCT ID: NCT05636436
Last Updated: 2024-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
132 participants
INTERVENTIONAL
2022-12-07
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Low dose vaccine group in adults aged 18 to 49 years
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).
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.
Low dose adjuvant group in adults aged 18 to 49 years
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).
Low dose adjuvant
0.5 mL per dose, containing low dose MA105 adjuvant.
High dose vaccine group in adults aged 18 to 49 years
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).
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.
High dose adjuvant group in adults aged 18 to 49 years
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).
High dose adjuvant
0.5 mL per dose, containing high dose MA105 adjuvant.
Placebo group in adults aged 18 to 49 years
Subjects aged 18 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Placebo
0.5 mL per dose, containing 4.5 mg sodium chloride.
Low dose vaccine group in adults aged 50 years and older
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).
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.
Low dose adjuvant group in adults aged 50 years and older
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).
Low dose adjuvant
0.5 mL per dose, containing low dose MA105 adjuvant.
High dose vaccine group in adults aged 50 years and older
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).
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.
High dose adjuvant group in adults aged 50 years and older
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).
High dose adjuvant
0.5 mL per dose, containing high dose MA105 adjuvant.
Shingrix® group in adults aged 50 years and older
Subjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).
Positive control
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
Placebo group in adults aged 50 years and older
Subjects aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Placebo
0.5 mL per dose, containing 4.5 mg sodium chloride.
Interventions
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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.
Low dose adjuvant
0.5 mL per dose, containing low dose MA105 adjuvant.
High dose adjuvant
0.5 mL per dose, containing high dose MA105 adjuvant.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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. Abnormal and clinically significant laboratory test results as determined by the investigator before vaccination;
17. Current or history of alcohol and/or drug abuse;
18. Any condition that, in the opinion the investigator, may affect the safety of the subject or the evaluation of the study results.
18 Years
ALL
Yes
Sponsors
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Henan Center for Disease Control and Prevention
OTHER_GOV
MAXVAX Biotechnology Limited Liability Company
INDUSTRY
Responsible Party
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Principal Investigators
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Yanxia Wang
Role: PRINCIPAL_INVESTIGATOR
Henan Center for Disease Control and Prevention
Locations
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Yanjin District Center for Disease Control and Prevention
Xinxiang, Henan, China
Countries
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Other Identifiers
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MKKCT-100-001
Identifier Type: -
Identifier Source: org_study_id
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