Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above
A Phase I, Single Center, Randomized, Blinded, Controlled Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above
1 other identifier
interventional
132
1 country
1
Brief Summary
The purposes of the study are to evaluate the safety and tolerability of different dose levels of recombinant herpes zoster vaccine (CHO Cells) with 2 doses at 2-month intervals in healthy subjects aged 18 years and older, and to preliminarily explore immunogenicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedStudy Start
First participant enrolled
December 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedNovember 20, 2024
November 1, 2024
2.1 years
November 16, 2022
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
The incidence and severity of adverse events
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.
Within 30 minutes after each vaccination.
The incidence and severity of adverse events
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.
Within 7 days after each vaccination.
The incidence and severity of adverse events
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.
Day 8 to 30 after each vaccination.
The incidence and severity of adverse events
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.
Within 30 days after each vaccination.
Incidence of abnormal and clinically significant laboratory test results
Laboratory test includes hematology, blood biochemistry and urine analysis.
Day 4 after each vaccination .
Secondary Outcomes (25)
Incidence of Serious Adverse Event
From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Potential Immune Mediated Disorder
From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Prior to each vaccination (Day 0, Day 60).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Day 14 after each vaccination (Day 14, Day 74).
Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
Month 1 after each vaccination (Day 30, Day 90).
- +20 more secondary outcomes
Study Arms (11)
Low dose vaccine group in adults aged 18 to 49 years
EXPERIMENTALSubjects 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 adjuvant group in adults aged 18 to 49 years
EXPERIMENTALSubjects aged 18 to 49 years will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
High dose vaccine group in adults aged 18 to 49 years
EXPERIMENTALSubjects 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 adjuvant group in adults aged 18 to 49 years
EXPERIMENTALSubjects aged 18 to 49 years will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Placebo group in adults aged 18 to 49 years
PLACEBO COMPARATORSubjects aged 18 to 49 years 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
EXPERIMENTALSubjects 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 adjuvant group in adults aged 50 years and older
EXPERIMENTALSubjects aged 50 years and older will be vaccinated with 2 doses of low dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
High dose vaccine group in adults aged 50 years and older
EXPERIMENTALSubjects 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 adjuvant group in adults aged 50 years and older
EXPERIMENTALSubjects aged 50 years and older will be vaccinated with 2 doses of high dose adjuvant on a 0, 2 month schedule, administered intramuscularly (IM).
Shingrix® group in adults aged 50 years and older
ACTIVE COMPARATORSubjects 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 50 years and older
PLACEBO COMPARATORSubjects aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).
Interventions
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.
0.5 mL per dose, containing low dose MA105 adjuvant.
0.5 mL per dose, containing high dose MA105 adjuvant.
0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.
0.5 mL per dose, containing 4.5 mg sodium chloride.
Eligibility Criteria
You may qualify if:
- Permanent residents aged 18 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.
You may not qualify if:
- 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);
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yanjin District Center for Disease Control and Prevention
Xinxiang, Henan, 453200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanxia Wang
Henan Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
December 5, 2022
Study Start
December 7, 2022
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share