A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine

NCT ID: NCT06801509

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2027-10-10

Brief Summary

The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.

Conditions

Herpes Zoster

Study Design

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

Study Groups

Low-Dose Vaccine Group

Group Type: EXPERIMENTAL

Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

Intervention Type: BIOLOGICAL

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

High-Dose Vaccine Group

Group Type: EXPERIMENTAL

Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

Intervention Type: BIOLOGICAL

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

Placebo Group

Group Type: PLACEBO_COMPARATOR

Placebo control: Saline

Intervention Type: BIOLOGICAL

The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart;

Shingrix® Group

Group Type: ACTIVE_COMPARATOR

Shingrix®

Intervention Type: BIOLOGICAL

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart

Ganwei® Group

Herpes zoster vaccine, live; Changchun BCHT

Group Type: ACTIVE_COMPARATOR

Ganwei®

Intervention Type: BIOLOGICAL

Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60；

Interventions

Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

Intervention Type: BIOLOGICAL

Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;

Intervention Type: BIOLOGICAL

Placebo control: Saline

The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart;

Intervention Type: BIOLOGICAL

Shingrix®

Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart

Intervention Type: BIOLOGICAL

Ganwei®

Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60；

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects ≥ 40 years of age;

2. The subject can and fully understand the trial procedures and voluntarily sign the ICF;

3. The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;

4. The subject can comply with the requirements of the protocol;

5. The axillary temperature of the subject is < 37.0℃ on the day of enrollment;

6. Fertile men and women with childbearing potential voluntarily agree to take effective contraceptive measures from the first vaccination to at least 90 days after the last dose of study vaccines.

Exclusion Criteria

1. History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;

2. Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);

3. Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.

4. History or family history of convulsions, epilepsy, and psychiatric disorders;

5. Suffering from serious chronic diseases or in the active stage of chronic diseases, which are evaluated by the investigator to affect the trial observation, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, hypertension that cannot be controlled after drug treatment (subjects 40-59 years of age have systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, and subjects ≥60 years of age have systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg), diabetes with severe complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart disease, respiratory diseases, liver and kidney diseases, and thyroid diseases;

6. Primary or secondary immunosuppressive condition, or diagnosed with primary or acquired immunodeficiency disease, human immunodeficiency virus (HIV) infection, etc.

7. History of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection and venous blood collection;

8. Fever (axillary temperature ≥37.3℃) within 3 days before enrollment or systemic antibiotic or antiviral treatment within 7 days;

9. Use of antipyretic analgesics or other drugs with antipyretic and analgesic effects, such as acetaminophen and ibuprofen, within 72 h before vaccination.

10. Abnormal laboratory test (blood routine, blood biochemistry, urine routine) results that are outside the reference range and clinically significant (only apply to Phase I);

11. Those who are pregnant (positive urine pregnancy test) or breast-feeding, or those who plan to become pregnant during the study period;

12. Long-term or high-dose corticosteroid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other corticosteroids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination. Short-term or topical use (such as ointments, eye drops, inhalants, intra-articular medications or nasal sprays) of glucocorticoids is permitted;

13. Vaccination with non-attenuated vaccines within 14 days before the first dose of study vaccines, or with live-attenuated vaccines within 28 days before the first dose of study vaccines;

14. Participation in other clinical trials (drug or vaccine) within 30 days preceding the first dose of study vaccines or planning to participate in other clinical trials before this clinical study is completed;

15. Asplenia or functional asplenia;

16. Those who are known to have been diagnosed or currently have an infectious disease, including hepatitis B, hepatitis C, syphilis or AIDS;

17. Those who have any acute illness or acute onset of chronic illness within 72 hours before the first dose of vaccination;

18. Those who have received blood or blood-related products, including immunoglobulins, within 3 months before the first dose of vaccination, or have planned to use them during the study period;

19. Subjects deemed by the investigator to have other conditions that render them ineligible to participate in this study, which include but are not limited to those who are incapable of participating in follow-up visits based on the protocol.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dazhu CDC

Dazhou, Sichuan, China

Countries

China

Central Contacts

Dongyang Gao, Doctor

Role: CONTACT

dongyang_gao@sinocelltech.com

+86-010-58628288-9137

Facility Contacts

Yulin Jing, Doctor

Role: primary

21820422@qq.com

+86-028-85596863

Other Identifiers

SCTV04C-X201

Identifier Type: -

Identifier Source: org_study_id