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Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

NCT06874842 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-04-01

No results posted yet for this study

Summary

This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

Conditions

  • Herpes Zoster (HZ)

Interventions

BIOLOGICAL

Low dose antigen and low dose adjuvant of LYB004

0.5 mL per dose, containing a total of 25 μg VZV-gEM adjuvanted with A01C.

BIOLOGICAL

Low dose antigen and high dose adjuvant of LYB004

0.5 mL per dose, containing a total of 25 μg VZV-gEM adjuvanted with A01B.

BIOLOGICAL

High dose antigen and low dose adjuvant of LYB004

0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01C.

BIOLOGICAL

High dose antigen and high dose adjuvant of LYB004

0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01B.

BIOLOGICAL

Placebo

0.5 mL per dose, without antigen and adjuvant.

BIOLOGICAL

Positive control

0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.

Sponsors & Collaborators

  • Guangzhou Patronus Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Renfeng Fan · Guangdong Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2026-02-28
Completion
2026-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06874842 on ClinicalTrials.gov