NCT07208461

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older

A Phase Ⅱ, Randomized, Observer-blinded, Placebo-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Older Adults Aged 60 Years and Older

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, observer-blinded, placebo-controlled Phase Ⅱ clinical trial to evaluate the immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.

Detailed description

A randomized, observer-blinded, placebo-controlled trial will be conducted to observe the immunogenicity and safety of LYB005 in adults aged 60 years and older. A total of 700 participants aged 60 years and older will be enrolled. Six formulations of LYB005 will be provided, three dose levels of antigen with or without A01B adjuvant. All participants will randomly receive six investigational vaccines and the placebo in a 1:1:1:1:1:1:1 ratio.

Conditions

• Respiratory Syncytial Virus Infection Prevention

Interventions

Type	Name	Description
BIOLOGICAL	Low dose antigen of LYB005 without A01B adjuvant	0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.
BIOLOGICAL	Low dose antigen of LYB005 with A01B adjuvant	0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.
BIOLOGICAL	Middle dose antigen of LYB005 without A01B adjuvant	0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.
BIOLOGICAL	Middle dose antigen of LYB005 with A01B adjuvant	0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.
BIOLOGICAL	High dose antigen of LYB005 without A01B adjuvant	0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.
BIOLOGICAL	High dose antigen of LYB005 with A01B adjuvant	0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.
BIOLOGICAL	Placebo	0.5 mL 0.9% sodium chloride (normal saline) injection per dose

Timeline

• Start date: 2025-10-21
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2025-10-06
• Last updated: 2026-02-11

Locations

1 site across 1 country: China