Clinical trial NCT05636436: Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Herpes Zoster
Lead sponsor: MAXVAX Biotechnology Limited Liability Company
Sponsor class: INDUSTRY
Collaborators: name: Henan Center for Disease Control and Prevention
First posted: 2022-12-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
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 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.

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 18 to 49 years and 50 years and older, with progression from low dose level to high dose level and younger age group to the older age group based on assessment of safety and tolerability. The younger cohort (aged 18 to 49 years) will consist of 60 subjects, 30 per dose level, and these 30 subjects will be randomized into three subgroups, including vaccine group, adjuvant group and normal saline group, with randomization ratio of 2:2:1. The older cohort (aged 50 years and older) will consist of 72 subjects, 36 per dose level, and these 36 subjects will be randomized into four subgroups, including vaccine group, adjuvant group, Shingrix® group and normal saline group, with randomization ratio of 2:2:1:1.

Eligibility criteria: Inclusion Criteria:

1. Permanent residents aged 18 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. 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.

Primary outcomes:
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.
measure: Incidence of abnormal and clinically significant laboratory test results
timeFrame: Day 4 after each vaccination .
Secondary outcomes:
measure: Incidence of Serious Adverse Event
timeFrame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
measure: Potential Immune Mediated Disorder
timeFrame: From the first vaccination to 12 months after full vaccination (From Day 0 to Day 420).
measure: Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
timeFrame: Prior to each vaccination (Day 0, Day 60).
measure: Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
timeFrame: Day 14 after each vaccination (Day 14, Day 74).
measure: Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
timeFrame: Month 1 after each vaccination (Day 30, Day 90).
measure: Geometric mean concentration (GMC) of anti-gE antibody and anti-VZV antibody
timeFrame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
measure: Seroconversion rate of anti-gE antibody and anti-VZV antibody
timeFrame: Prior to the second vaccination (Day 60).
measure: Seroconversion rate of anti-gE antibody and anti-VZV antibody
timeFrame: Day 14 after each vaccination (Day 14, Day 74).
measure: Seroconversion rate of anti-gE antibody and anti-VZV antibody
timeFrame: Month 1 after each vaccination (Day 30, Day 90).
measure: Positive rate of anti-gE antibody and anti-VZV antibody
timeFrame: Prior to each vaccination (Day 0, Day 60).
measure: Positive rate of anti-gE antibody and anti-VZV antibody
timeFrame: Day 14 after each vaccination (Day 14, Day 74).
measure: Positive rate of anti-gE antibody and anti-VZV antibody
timeFrame: Month 1 after each vaccination (Day 30, Day 90).
measure: Positive rate of anti-gE antibody and anti-VZV antibody
timeFrame: Month 6 and 12 after the second vaccination (Day 240, Day 420).
measure: Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
timeFrame: Prior to the second vaccination (Day 60).
measure: Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
timeFrame: Day 14 after each vaccination (Day 14, Day 74).
measure: Geometric mean increase(GMI) of anti-gE antibody and anti-VZV antibody concentration
timeFrame: Month 1 after each vaccination (Day 30, Day 90)
measure: Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
timeFrame: Prior to the second vaccination (Day 60).
measure: Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
timeFrame: Day 14 after each vaccination (Day 14, Day 74).
measure: Four-fold increase rate of the anti-gE antibody and anti-VZV antibody concentration
timeFrame: Month 1 after each vaccination (Day 30, Day 90).
measure: Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
timeFrame: Prior to the first vaccination (Day 0).
measure: Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
timeFrame: Month 1 after the second vaccination (Day 90).
measure: Frequency of gE-specific CD4+ T-cells expressing at least 1 Immunological activation marker
timeFrame: Month 6, 12 after the second vaccination (Day 240, Day 420).
measure: Cellular immune response
timeFrame: Prior to the first vaccination (Day 0).
measure: Cellular immune response
timeFrame: Month 1 after the second vaccination (Day 90).
measure: Cellular immune response
timeFrame: Month 6, 12 after the second vaccination (Day 240, Day 420)
Other outcomes:
Locations:
city: Xinxiang
country: China
facility: Yanjin District 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: