Prevention of Herpes Zoster
Conditions
Keywords
IV Clinical Trial, Herpes Zoster Vaccine, Live, Herpes Zoster, Prevention of Herpes Zoster
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.
Interventions
BIOLOGICALHerpes Zoster Vaccine, Live
assigned to the vaccine group and placebo group in a 2:1 ratio.
BIOLOGICALPlacebo
assigned to the vaccine group and placebo group in a 2:1 ratio.
Sponsors
Inner Mongolia Center for Disease Control and Prevention
Center for Disease Control and Prevention, Fujian
Changchun BCHT Biotechnology Co.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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。
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity: | Day 0 and Day 42 | Geometric mean titer (GMT)at Day 0 and Day 42. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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。 |
Contacts
Primary Contactshaohong yan, Undergraduate degree
Outcome results
None listed