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

PHASE1RecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

March 13, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

October 31, 2026

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.

Trial Locations (1)

Unknown

RECRUITING

Guangdong Provincial Center for Disease Control and Prevention, Meizhou

All Listed Sponsors
lead

Guangzhou Patronus Biotech Co., Ltd.

INDUSTRY