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

Changchun BCHT Biotechnology

Status and phase: Not yet enrolling; Phase 4

Conditions: Prevention of Herpes Zoster

Treatments: Biological: Placebo; Biological: Herpes Zoster Vaccine, Live

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06961721

PFDP20241008

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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。

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Experimental vaccine：Herpes Zoster Vaccine, Live

Experimental group

Description:

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

Treatment:

Biological: Herpes Zoster Vaccine, Live

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

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo