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ACTIVE NOT RECRUITING
NCT06904222
PHASE1

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

Sponsor: Guangzhou Patronus Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-04-15

Completion Date

2026-08

Last Updated

2025-08-22

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Dangyang City Center for Disease Control and Prevention

Dangyang, China