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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
960
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.
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 \[only applicable to the Phase II Experimental Vaccine Group B2\].
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, China
The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose.
Time frame: Within 14 days after each vaccine dose.
The incidence of unsolicited adverse events (AEs) within 0-30 days after each vaccine dose.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Detected using intracellular cytokine staining (ICS) by flow cytometry
Time frame: One month after full immunization.(Applicable to Phase Ⅱ only)
The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies one month after full immunization.
Detected using enzyme-linked immunosorbent assay (ELISA).
Time frame: One month after full immunization.(Applicable to Phase Ⅱ only)
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.
Detected using enzyme-linked immunosorbent assay (ELISA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
The dosage for each administration is 0.5 mL, containing 50 μg of gE and the AS01B adjuvant system \[QS-21 (50 μg), MPL (50 μg), DOPC (1 mg), and cholesterol (0.25 mg)\], administered intramuscularly into the deltoid muscle. A total of two doses will be given, with the second dose administered 60 days after the first dose.
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.
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).
Time frame: At 6, 12, 24, and 36 months after full immunization.(Applicable to Phase Ⅱ only)
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.
Detected using intracellular cytokine staining (ICS) by flow cytometry
Time frame: Before the second dose and at 6, 12, 24, and 36 months after full immunization(Applicable to Phase Ⅱ only)