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ACTIVE NOT RECRUITING
NCT06442241
PHASE1

A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine, LYB005 in Healthy Adults

Sponsor: Guangzhou Patronus Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

A phase 1, randomized, observer-blinded, parallel-controlled, dose escalation study in Australia will evaluate the safety and immunogenicity of the RSV vaccine candidate LYB005 with or without adjuvant in healthy adults aged 18 years and older.

Official title: A Phase I, Randomized, Observer-Blinded, Parallel-Controlled, Dose Escalation Study to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell), LYB005, in Healthy Adults Aged 18 Years and Older

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-07-31

Completion Date

2025-12-30

Last Updated

2025-03-13

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

LYB005 low dose without adjuvant

Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

BIOLOGICAL

LYB005 middle dose without adjuvant

Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

BIOLOGICAL

LYB005 high dose without adjuvant

Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

BIOLOGICAL

LYB005 low dose with adjuvant

Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

BIOLOGICAL

LYB005 middle dose with adjuvant

Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

BIOLOGICAL

LYB005 high dose with adjuvant

Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

BIOLOGICAL

Placebo

0.9% sodium chloride injection. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

BIOLOGICAL

Positive control

AREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

Locations (1)

Nucleus Network Pty Ltd.

Melbourne, Australia