A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of a Live Attenuated Herpes Zoster Vaccine in Adults Aged 40 Years and Older

Phase 4

Not yet recruiting

• Conditions: Prevention of Herpes Zoster
• Interventions: Biological: Herpes Zoster Vaccine, Live; Biological: Placebo

• Registration Number: NCT06961721
• Lead Sponsor: Changchun BCHT Biotechnology Co.

Brief Summary

To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine.

To evaluate the safety of the live attenuated herpes zoster vaccine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-23
• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Age ≥40 years on enrollment day；
2. The informed consent of the subject can be obtained and signed；
3. The subjects themselves were able to complete the trial in accordance with the requirements of the clinical trial protocol；
4. Armpit body temperature ≤37.0℃ on the day of enrollment.

Exclusion Criteria

1. People who are immune deficient or immunosuppressed due to certain diseases or treatments. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency conditions, such as AIDS or other diseases caused by viral infection; Leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; Being treated for immunosuppression; Being treated with radiation/chemotherapy for a tumor；
2. Do not use in persons with a history of allergic reaction to any of the components contained in this product；
3. Those who are in the acute stage of acute infection and chronic infection should postpone the vaccination of this product；
4. Premenopausal women who tested positive for pregnancy, pregnant women, breastfeeding women, or those who planned to have a baby within 6 months；
5. If this product and other injectable live attenuated vaccines are not administered at the same time, the interval should be at least 28 days；
6. Treatment with whole blood, plasma, or immunoglobulin is given within 5 months or 3 weeks prior to vaccination；
7. Received another investigational drug within 1 month prior to receiving the investigational vaccine/placebo, or is participating in another clinical trial, or plans to use it during the study；
8. Taking or about to take salicylate drugs, including aspirin and difluorosalicylic acid；
9. Patients with abnormal blood pressure that cannot be controlled by medication (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
10. Previous vaccinations against chickenpox or shingles (including use of registered products or participation in clinical trials of chickenpox or shingles vaccine)；
11. Any situation that the investigator considers likely to affect the evaluation of the trial。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental vaccine：Herpes Zoster Vaccine, Live	Herpes Zoster Vaccine, Live	After reconstitution, 0.5 ml per bottle. The dose per person is 0.5 ml.
Identical to the test vaccine but without the varicella-zoster virus.	Placebo	After redissolving, 0.5 ml per bottle. The dose is 0.5 ml per dose for human and does not contain varicella-zoster live virus.

Primary Outcome Measures

Name	Time	Method
Immunogenicity:	Day 0 and Day 42	seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	42 days	1. Incidence, severity, and causality of solicited local，systemic adverse events within 14 days post-vaccination； 2. The incidence and severity of unsolicited adverse events within 42 days after vaccination and their association with vaccination； 3. Incidence of Serious Adverse events (SAE) within 42 days after vaccination。