A Phase I/II Clinical Trial with Randomized, Blinded, Controlled Design to Evaluate the Safety and Immunogenicity of the Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Populations Aged 40 Years and Older Post -vaccination
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
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• Male or female participants aged 40 years or older at the time of enrollment.
• Voluntarily agrees to participate in the trial, fully understands, and signs the informed consent form.
• Able to attend all scheduled follow-ups and comply with the clinical trial protocol requirements to complete the trial.
• Female participants must meet the following criteria:1)Surgically sterilized or postmenopausal for ≥2 years, or women of childbearing potential (not menopausal or menopausal \<2 years) with a negative pregnancy test and willing to use effective physical contraception (e.g., condoms, intrauterine device) from enrollment until 6 months after full immunization. 2)Agree not to breastfeed from enrollment until 6 months after full immunization.
• Axillary temperature ≤37.0°C.
Locations
Other Locations
China
Xiangcheng County Center for Disease Control and Prevention
It is used for vaccination of experimental vaccine group B subjects of phase I clinical trial , experimental vaccine group B1 and B2 subjects of phase II clinical trial
Active_comparator: Zoster Vaccine, Live
It is used for vaccination of positive control group A1 and A2 subjects in phase Ⅱ clinical trial
It is used for vaccination of adjuvant control group subjects in phase Ⅰ clinical trial
Placebo_comparator: normal saline
Used in phase Ⅰ clinical trial; To maintain blinding, positive control group A1 and positive control group A2 received placebo on day 0 (for phase II clinical trial).