Clinical trial NCT05856084: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Herpes Zoster
Lead sponsor: MAXVAX Biotechnology Limited Liability Company
Sponsor class: INDUSTRY
Collaborators: name: Henan Center for Disease Control and Prevention
First posted: 2023-05-12
Enrollment: 924
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: Geometric mean concentration (GMC) of anti-gE antibody
timeFrame: Month 1 after the last vaccination
measure: Seropositivity rate of anti-gE antibody
timeFrame: Month 1 after the last vaccination
measure: Seroresponse rate of anti-gE antibody
timeFrame: Month 1 after the last vaccination
measure: Geometric Mean Fold Rise (GMFR) of anti-gE antibody concentration
timeFrame: Month 1 after the last vaccination
measure: Four-fold increase rate of anti-gE antibody concentration
timeFrame: Month 1 after the last vaccination
measure: Cell-Mediated Immunity (CMI) response
timeFrame: Month 1 after the last vaccination
measure: Vaccine Response Rate (VRR)
timeFrame: Month 1 after the last vaccination
measure: The incidence and severity of adverse events
timeFrame: Within 30 minutes after each vaccination
measure: The incidence and severity of adverse events
timeFrame: Within 7 days after each vaccination
measure: The incidence and severity of adverse events
timeFrame: Day 8 to 30 after each vaccination
measure: The incidence and severity of adverse events
timeFrame: Within 30 days after each vaccination
Secondary outcomes:
measure: The incidence of Serious Adverse Events
timeFrame: From the first vaccination to 12 months after the last vaccination
measure: Potential Immune-Mediated Diseases
timeFrame: From the first vaccination to 12 months after the last vaccination
measure: Geometric mean concentration (GMC) of anti-VZV antibody
timeFrame: Month 1 after the last vaccination
measure: Seropositivity rate of anti-VZV antibody
timeFrame: Month 1 after the last vaccination
measure: Seroresponse rate of anti-VZV antibody
timeFrame: Month 1 after the last vaccination
measure: Geometric Mean Fold Rise (GMFR) of anti-VZV antibody
timeFrame: Month 1 after the last vaccination
measure: Four-fold increase rate of anti-VZV antibody
timeFrame: Month 1 after the last vaccination
measure: Geometric mean concentration (GMC) of anti-gE antibody
timeFrame: At 6, 12 and 24 months after the last vaccination
measure: Seropositivity rate of anti-gE antibody
timeFrame: At 6, 12 and 24 months after the last vaccination
measure: Geometric mean concentration (GMC) of anti-VZV antibody
timeFrame: At 6, 12 and 24 months after the last vaccination
measure: Seropositivity rate of anti-VZV antibody
timeFrame: At 6, 12 and 24 months after the last vaccination
measure: Cell-Mediated Immunity (CMI) response
timeFrame: At 6, 12 and 24 months after the last vaccination
measure: Vaccine Response Rate (VRR)
timeFrame: At 6, 12 and 24 months after the last vaccination
Other outcomes:
Locations:
city: Xinxiang
country: China
facility: Yanjin Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Center for Disease Control and Prevention
name: Yanxia Wang
role: PRINCIPAL_INVESTIGATOR
References: