NCT06904222

Safety and Immunogenicity of the Recombinant Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 18 Years and Older

A Phase I, Randomized, Observer-blinded, Placebo-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Adults Aged 18 Years and Older

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This phase 1 study in China will evaluate the safety and immunogenicity of the the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in adults aged 18 years and older.

Detailed description

A randomized, observer-blinded, placebo-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB005 in adults aged 18 years and older. A total of 90 healthy subjects will be enrolled and stratified by age (18-59 years and ≥60 years in a 1:1 ratio). Six formulations of LYB005 will be provided, three dose levels of antigen with or without A01B adjuvant. A sentinel and escalating dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be enrolled in one of six cohorts, including Cohort 1 (18-59 years, low dose, n=15), Cohort 2 (18-59 years, middle dose, n=15), Cohort 3 (≥60 years, low dose, n=15), Cohort 4 (18-59 years, high dose, n=15), Cohort 5 (≥60 years, middle dose, n=15), and Cohort 6 (≥60 years, high dose, n=15). In each cohort, five sentinels were set up, and they were randomly vaccinated with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo in a 2:2:1 ratio. The remaining participants were randomly vaccinated in a 2:2:1 ratio with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo. A single-dose immunization schedule will be adopted.

Conditions

• Respiratory Syncytial Virus Infection

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: 2025-04-15
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-04-01
• Last updated: 2025-08-22

Locations

1 site across 1 country: China