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

NCT06874842 Phase 1 RECRUITING

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.

Details

Lead sponsor	Guangzhou Patronus Biotech Co., Ltd.
Phase	Phase 1
Status	RECRUITING
Enrolment	92
Start date	2025-03-13
Completion	2026-10

Conditions

• Herpes Zoster (HZ)

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

• Occurrence of immediate adverse events — Within 30 minutes after each vaccination
  The incidence and severity of any adverse events (AEs) within 30 minutes after each vaccination
• Incidence of solicited AE — Within 0-14 days after each vaccination
  Occurrence and severity of solicited local injection site reactions for 14 days (Day 0-Day 14) following each vaccination. (i.e., pain, redness, swelling). Occurrence and severity of solicited systemic reactions for 14 days (Day 0-Day 14) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever).
• Incidence of unsolicited AEs — Within 30 days after each vaccination
  The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Days 0\~30 after the study intervention. vaccination
• Incidence of clinically significant abnormalities in clinical laboratory tests — 3 days after each vaccination
  The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, coagulation function, and urinalysis) on Day 3 after each vaccination

Countries

China