Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older

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.

Conditions

• Herpes Zoster
• Herpes Zoster Vaccine

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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 \[only applicable to the Phase II Experimental Vaccine Group B2\].

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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).

Sponsors & Collaborators

• Yither Biotechnology Co., Ltd

  collaborator UNKNOWN

• Ab&B Bio-tech Co., Ltd.JS

  lead OTHER

Principal Investigators

• Zhiqiang Xie, Master · Henan Center for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-16

Primary Completion

2026-09-16

Completion

2028-09-16

Countries

• China

Study Locations