Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Condition(s) studied
Investigational drug(s) / intervention(s)
Recombinant 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.
Recombinant 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 \[only applicable to the Phase II Experimental Vaccine Group B2\].
Zoster 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.
Recombinant Zoster Vaccine (CHO cell): 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.
Recombinant 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.
Normal 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).
Study 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
Primary outcome measure(s)
- 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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Xiangcheng County Center for Disease Control and Prevention | Xuchang | Henan |
More Ab&B Bio-tech Co., Ltd.JS trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06851832 on ClinicalTrials.gov ↗ ← All trials in China