Herpes Zoster, Herpes Zoster Vaccine
Conditions
Brief 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.
Interventions
BIOLOGICALRecombinant zoster vaccine(CHO cell)(low adjuvant)
The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 50 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose.
BIOLOGICALRecombinant Zoster Vaccine (CHO cell)
The dosage for each administration is 0.5 mL, containing 50 μg of gE, 0.25 mL of MF59, and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. Vaccination Schedule 1: A total of two doses will be given, with the second dose administered 30 days after the first dose. Vaccination Schedule 2: A total of two doses will be given, with the second dose administered 60 days after the first dose \[only applicable to the Phase II Experimental Vaccine Group B2\].
BIOLOGICALZoster Vaccine, Live
The dosage for each administration is 0.5 mL, containing not less than 4.3 lg PFU of varicella-zoster live virus, administered subcutaneously at the attachment site of the lower edge of the deltoid muscle on the outer side of the upper arm. A total of one dose will be given. To maintain blinding, the positive control group A1 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 30. The positive control group A2 will receive a placebo on Day 0 and the Zoster Vaccine, Live on Day 60.
BIOLOGICALRecombinant Zoster Vaccine (CHO cell) (Adjuvant control)
The dosage for each administration is 0.5 mL, containing 0.25 mL of MF59 and 100 μg of CpG1018, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose.
BIOLOGICALNormal Saline
The dosage for each administration is 0.5 mL, containing 0.5 mL of NaCl solution, administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 30 days after the first dose (applicable to Phase I clinical trial). To maintain blinding, subjects in the positive control A1 and positive control A2 groups will receive a placebo on Day 0 (applicable to Phase II clinical trial).
Sponsors
Ab&B Bio-tech Co., Ltd.JS
Yither Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose. | Within 14 days after each vaccine dose. | — |
| The incidence of unsolicited adverse events (AEs) within 0-30 days after each vaccine dose. | Within 30 days after each vaccine dose. | — |
| The incidence of laboratory abnormalities (including blood biochemistry, blood routine, urine routine and electrocardiogram) on Day 3 after each vaccine dose. | On Day 3 after each vaccine dose.（Applicable to Phase I only） | — |
| The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) from the vaccination of the first dose to 12 months after full immunization. | From the vaccination of the first dose to 12 months after full immunization. | — |
| The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) one month after full immunization. | One month after full immunization.（Applicable to Phase Ⅱ only） | Detected using intracellular cytokine staining (ICS) by flow cytometry |
| The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies one month after full immunization. | One month after full immunization.（Applicable to Phase Ⅱ only） | Detected using enzyme-linked immunosorbent assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies at 6, 12, 24, and 36 months after full immunization. | At 6, 12, 24, and 36 months after full immunization.（Applicable to Phase Ⅱ only） | Detected using enzyme-linked immunosorbent assay (ELISA) |
| The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) before the second dose and at 6, 12, 24, and 36 months after full immunization. | Before the second dose and at 6, 12, 24, and 36 months after full immunization（Applicable to Phase Ⅱ only） | Detected using intracellular cytokine staining (ICS) by flow cytometry |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZhiqiang Xie, Master
Henan Center for Disease Control and Prevention
Outcome results
None listed