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

NCT06442241 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus (RSV)
  • RSV Infection

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.

Sponsors & Collaborators

  • Yantai Patronus Biotech Co., Ltd.

    collaborator INDUSTRY

  • Guangzhou Patronus Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Christina Chang, M.D · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06442241 on ClinicalTrials.gov