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

NCT ID: NCT06961721

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-12-31

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.

Conditions

Prevention of Herpes Zoster

Study Design

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

Study Groups

Experimental vaccine：Herpes Zoster Vaccine, Live

After reconstitution, 0.5 ml per bottle. The dose per person is 0.5 ml.

Group Type: EXPERIMENTAL

Herpes Zoster Vaccine, Live

Intervention Type: BIOLOGICAL

assigned to the vaccine group and placebo group in a 2:1 ratio.

Identical to the test vaccine but without the varicella-zoster virus.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

assigned to the vaccine group and placebo group in a 2:1 ratio.

Interventions

Herpes Zoster Vaccine, Live

assigned to the vaccine group and placebo group in a 2:1 ratio.

Intervention Type: BIOLOGICAL

Placebo

assigned to the vaccine group and placebo group in a 2:1 ratio.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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。

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

Sponsors

Inner Mongolia Center for Disease Control and Prevention

UNKNOWN

Sponsor Role: collaborator

Center for Disease Control and Prevention, Fujian

OTHER

Sponsor Role: collaborator

Changchun BCHT Biotechnology Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

shaohong yan, Undergraduate degree

Role: CONTACT

E-yshid2005@163.com

13015018766

Other Identifiers

PFDP20241008

Identifier Type: -

Identifier Source: org_study_id