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
1 other identifier
interventional
84
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMarch 13, 2025
March 1, 2025
1.4 years
May 28, 2024
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Immediate AEs for 30 minutes post-vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after the vaccination
30 mins after vaccination
Solicited local and systemic AEs and unsolicited AEs
The incidence and severity of any solicited local and systemic AEs and unsolicited AEs within 7 days after the vaccination
Within 7 days after vaccination
Unsolicited AEs
The incidence and severity of any unsolicited AEs within 28 days after the vaccination
Within 28 days after vaccination
Clinically significant laboratory abnormalities
The occurrence of clinically significant laboratory abnormalities 3 days, 7 days, 28 days and 90 days after vaccination
Day 4, Day 8, Day 29 and Day 91
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) within 6 months after the vaccination
Within 6 months after the vaccination
Secondary Outcomes (4)
To observe the humoral immunity (antibodies level) of LYB005 vaccine
Day 15 and Day 29
To observe the persistence of humoral immunity (antibodies level) of LYB005 vaccine
Day 91 and Day 181
To observe the humoral immunity (increase in antibodies level) of LYB005 vaccine
Day 15 and Day 29
To observe the persistence of humoral immunity (increase in antibodies level) of LYB005 vaccine
Day 91 and Day 181
Study Arms (14)
Group 1 (LYB005 low dose without adjuvant; young adults)
EXPERIMENTALYoung adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1.
Group 2 (LYB005 middle dose without adjuvant; young adults)
EXPERIMENTALYoung adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1.
Group 3 (LYB005 high dose without adjuvant; young adults)
EXPERIMENTALYoung adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1.
Group 4 (LYB005 low dose with adjuvant; young adults)
EXPERIMENTALYoung adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1.
Group 5 (LYB005 middle dose with adjuvant; young adults)
EXPERIMENTALYoung adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1.
Group 6 (LYB005 high dose with adjuvant; young adults)
EXPERIMENTALYoung adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1.
Group 7 (placebo; young adults)
PLACEBO COMPARATORYoung adults (18-59 years old) will receive a single injection of placebo on Day 1.
Group 8 (LYB005 low dose without adjuvant; older adults)
EXPERIMENTALOlder adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1.
Group 9 (LYB005 middle dose without adjuvant; older adults)
EXPERIMENTALOlder adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1.
Group 10 (LYB005 high dose without adjuvant; older adults)
EXPERIMENTALOlder adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1.
Group 11 (LYB005 low dose with adjuvant; older adults)
EXPERIMENTALOlder adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1.
Group 12 (LYB005 middle dose with adjuvant; older adults)
EXPERIMENTALOlder adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1.
Group 13 (LYB005 high dose with adjuvant; older adults)
EXPERIMENTALOlder adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1.
Group 14 (AREXVY; older adults)
ACTIVE COMPARATOROlder adults (≥60 years old) will receive a single injection of positive control AREXVY on Day 1.
Interventions
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
0.9% sodium chloride injection. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
AREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Eligibility Criteria
You may qualify if:
- Part 1-A male or female aged 18-59 years at screening; Part 2-A male or female aged 60 years and older at screening.
- Written informed consent obtained from the subject before any assessment is performed.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol. (e.g., complete the diary cards, and complete follow-up visits).
- Subjects must have a Body Mass Index (BMI) between ≥18.0 and ≤35.0 kg/m\^2 at screening.
- Female subjects who are not pregnant or lactating. Female subjects with childbearing potential and their partners should use highly effective, medically accepted double-barrier contraception and will not have pregnancy and fertility plan and refrain from donating ovum from at least 28 days prior to study vaccination until study completion.
- A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Highly effective double-barrier contraception is defined as use of a condom AND one of the following: birth control pills (The Pill), depot or injectable birth control, intrauterine device (IUD), NuvaRing®, implantable contraception (e.g., Implanon).
- Note: There is no contraception requirement for female subjects with non-childbearing potential (WNCBP). There is no contraception requirement for female subjects with non-childbearing potential (WNCBP) and WNCBP subjects' male partners must use a condom from study vaccination/Day 1 until study completion.
- Males participating in this study who are involved in heterosexual sexual activity with a female partner of childbearing potential must agree to use highly effective, medically accepted double-barrier contraception (as described above) and refrain from donating sperm from at least 28 days prior to study vaccination until study completion; male participants with WNCBP partners must use a condom only from study vaccination/Day 1 until study completion.
You may not qualify if:
- Tympanic temperature \> 37.5°C at screening or prior to vaccination.
- History or presence of any respiratory infection symptoms within 7 days prior to vaccination.
- Previous vaccination against Respiratory Syncytial Virus (RSV). Planned administration of RSV vaccination during the study (including an investigational or non-registered vaccine), except for the investigational vaccine in this trial.
- Received a live attenuated vaccine within 28 days before vaccination or received other vaccines within 14 days before vaccination.
- Received any immunoglobulins or blood/plasma products within 3 months prior to vaccination.
- Individuals with the following diseases: 1）Any acute disease or acute attack of chronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 24 h prior to enrolment; 2）Allergies to any component of the investigational vaccine; 3）Subject has any clinically significant history of allergic conditions to other vaccines; 4）History of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders (bipolar disorder, schizophrenia, etc.) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 5）Asplenia, or functional asplenia; 6）Congenital or acquired immunodeficiency or autoimmune disease; 7）Chronic administration (≥14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (\<14 consecutive days) of oral corticosteroids; 8）Have severe cardiovascular diseases (cardiopulmonary disease, pulmonary edema), severe hepatic or renal diseases, and diabetes complications that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 9）History of severe thrombocytopenia or other coagulation disorders which may be contraindications for an IM; 10）Severe hypertension uncontrolled by medication with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; 11）Positive test for hepatitis C virus (HCV), hepatitis B surface antigen (HbsAg), human immunodeficiency virus (HIV) at screening.
- Clinically significant laboratory abnormalities determined by the investigator at screening.
- A positive urine drug test or alcohol breath test at screening or Day 1.
- Recent participated in another clinical trial, with receipt of the investigational drug/vaccine within 30 days prior to screening. Currently participating in or those planning to participate in another clinical trial during the study.
- Have donated blood or plasma within 2 weeks prior to screening.
- Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nucleus Network Pty Ltd.
Melbourne, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Chang, M.D
Nucleus Network Pty Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 4, 2024
Study Start
July 31, 2024
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share