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

NCT06801509 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SCTV04C-X201
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• phase 1: Incidence and intensity of solicited adverse events (AEs)

  within 14 days after each vaccination

• phase 1: Incidence and intensity of unsolicited AEs

  within 30 days after each vaccination

• phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody

  at 30 days after full vaccination

Secondary Outcomes (11)

• phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody

  at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination

• phase 1:Frequency and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by intracellular cytokine staining (ICS)

  at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination

• phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs)

  during the study (from the first vaccination to 12 months after full vaccination)

• phase 1: Incidence and intensity of abnormal laboratory tests indicators

  3 days after each vaccination

• phase 2: GMI of antigen-specific antibody

  at 30 days after full vaccination

Study Arms (5)

Low-Dose Vaccine Group

EXPERIMENTAL

Biological: Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

High-Dose Vaccine Group

EXPERIMENTAL

Biological: Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

Placebo Group

PLACEBO COMPARATOR

Biological: Placebo control: Saline

Shingrix® Group

ACTIVE COMPARATOR

Biological: Shingrix®

Ganwei® Group

ACTIVE COMPARATOR

Herpes zoster vaccine, live; Changchun BCHT

Biological: Ganwei®

Interventions

Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose BIOLOGICAL

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

Low-Dose Vaccine Group

Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose 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

Placebo control: Saline BIOLOGICAL

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

Placebo Group

Shingrix® 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

Shingrix® Group

Ganwei® 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；

Ganwei® Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 40 years of age;
• The subject can and fully understand the trial procedures and voluntarily sign the ICF;
• 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;
• The subject can comply with the requirements of the protocol;
• The axillary temperature of the subject is \< 37.0℃ on the day of enrollment;
• 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.

You may not qualify if:

• History of herpes zoster before enrollment, or close contact with a varicella/herpes zoster patient within 30 days prior to enrollment;
• Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);
• 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.
• History or family history of convulsions, epilepsy, and psychiatric disorders;
• 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;
• Primary or secondary immunosuppressive condition, or diagnosed with primary or acquired immunodeficiency disease, human immunodeficiency virus (HIV) infection, etc.
• History of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection and venous blood collection;
• Fever (axillary temperature ≥37.3℃) within 3 days before enrollment or systemic antibiotic or antiviral treatment within 7 days;
• Use of antipyretic analgesics or other drugs with antipyretic and analgesic effects, such as acetaminophen and ibuprofen, within 72 h before vaccination.
• Abnormal laboratory test (blood routine, blood biochemistry, urine routine) results that are outside the reference range and clinically significant (only apply to Phase I);
• Those who are pregnant (positive urine pregnancy test) or breast-feeding, or those who plan to become pregnant during the study period;
• 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;
• 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;
• 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;
• Asplenia or functional asplenia;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Dazhu CDC

Dazhou, Sichuan, 635100, China

Location

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Dongyang Gao, Doctor

CONTACT

+86-010-58628288-9137; dongyang_gao@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: February 15, 2025
• Primary Completion: November 10, 2025
• Study Completion (Estimated): October 10, 2027
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

CN (1)