NCT06442241

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Guangzhou Patronus Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study design includes an age- and dose-escalation (low/middle/high dose) in two adult age groups (young adults \[18-59 years\] and older adults \[≥60 years\]). Study will be conducted in two parts, part 1 will enrolled young adults and part 2 will enroll older adults. A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be divided into the sentinel cohort and the remainder of cohort. Participants in part 1 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Participants in part 2 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or positive control AREXVY. Detailed characterization of safety (including safety laboratory evaluation) and immune responses will be observed.

Conditions

• Respiratory Syncytial Virus (RSV)
• RSV Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-06-04
• Last updated: 2025-03-13

Locations

1 site across 1 country: Australia