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

Launched by CHANGCHUN BCHT BIOTECHNOLOGY CO. · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study a new vaccine aimed at preventing shingles, also known as herpes zoster, in adults aged 40 and older. The researchers want to find out how well the vaccine works and how safe it is by checking participants' immune responses 42 days after they receive it. The study will involve multiple locations, and participants will not know whether they are receiving the actual vaccine or a placebo (a harmless substance with no active vaccine).

To be eligible for this trial, you need to be at least 40 years old and able to provide informed consent, which means you understand the study and agree to participate. There are some important exclusions to keep in mind: if you have a weakened immune system, are currently pregnant or breastfeeding, or have had reactions to similar vaccines in the past, you may not be able to participate. If you join the study, you’ll be monitored for safety and any side effects after receiving the vaccine, and your health will be evaluated over the trial period. This study is a great opportunity to contribute to research that could help prevent shingles and improve community health.

Gender

ALL

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。