A Phase Ⅱ, Randomized, Observer-blinded, Parallel-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older

NCT07311148 Phase 2 ACTIVE_NOT_RECRUITING

This phase 2 study in China will evaluate the immunogenicity and safety of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.

Details

Lead sponsor	Guangzhou Patronus Biotech Co., Ltd.
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	840
Start date	2025-10-23
Completion	2026-12

Conditions

• Herpes Zoster (HZ)
• Shingles
• VZV
• Recombinant Zoster Vaccine

Interventions

• Low dose antigen and low dose adjuvant of LYB004
• Low dose antigen and high dose adjuvant of LYB004
• High dose antigen and low dose adjuvant of LYB004
• High dose antigen and high dose adjuvant of LYB004
• Placebo
• Positive control

Primary outcomes

• The geometric mean concentration (GMC) of anti-glycoprotein E (gE) antibody — 30 days after second vaccination
  Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
• The geometric mean titer (GMT) of anti-VZV antibody — 30 days after second vaccination
  Measured by fluorescent antibody to the membrane antigen (FAMA).

Countries

China