Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 30 Years and Above

NCT ID: NCT05856084

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 924 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-07
• Study Completion Date: 2026-03-31

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Low dose vaccine group in adults aged 30 to 49 years

Participants aged 30 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).

Group Type: EXPERIMENTAL

Low dose Recombinant Herpes Zoster Vaccine (CHO cells)

Intervention Type: BIOLOGICAL

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.

High dose vaccine group in adults aged 30 to 49 years

Participants aged 30 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).

Group Type: EXPERIMENTAL

High dose Recombinant Herpes Zoster Vaccine (CHO cells)

Intervention Type: BIOLOGICAL

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.

Placebo group in adults aged 30 to 49 years

Participants aged 30 to 49 years will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.5 mL per dose, containing 4.5 mg sodium chloride.

Low dose vaccine group in adults aged 50 years and older

Participants 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).

Group Type: EXPERIMENTAL

Low dose Recombinant Herpes Zoster Vaccine (CHO cells)

Intervention Type: BIOLOGICAL

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with low dose MA105.

High dose vaccine group in adults aged 50 years and older

Participants 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).

Group Type: EXPERIMENTAL

High dose Recombinant Herpes Zoster Vaccine (CHO cells)

Intervention Type: BIOLOGICAL

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with high dose MA105.

Shingrix® group in adults aged 50 years and older

Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).

Group Type: ACTIVE_COMPARATOR

Positive control

Intervention Type: BIOLOGICAL

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

Participants aged 50 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.5 mL per dose, containing 4.5 mg sodium chloride.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Positive control

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

Intervention Type: BIOLOGICAL

Placebo

0.5 mL per dose, containing 4.5 mg sodium chloride.

Intervention Type: BIOLOGICAL

Other Intervention Names

Shingrix®; Normal Saline for injection

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

MAXVAX Biotechnology Limited Liability Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanxia Wang

Role: PRINCIPAL_INVESTIGATOR

Henan Center for Disease Control and Prevention

Locations

Yanjin Center for Disease Control and Prevention

Xinxiang, Henan, China

Countries

China

Other Identifiers

MKKCT-100-002

Identifier Type: -

Identifier Source: org_study_id