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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06442241




Registration number
NCT06442241
Ethics application status
Date submitted
28/05/2024
Date registered
4/06/2024

Titles & IDs
Public title
A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine, LYB005 in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
LYB005-CT-AUS-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus (RSV) 0 0
RSV Infection 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - LYB005 low dose without adjuvant
Treatment: Other - LYB005 middle dose without adjuvant
Treatment: Other - LYB005 high dose without adjuvant
Treatment: Other - LYB005 low dose with adjuvant
Treatment: Other - LYB005 middle dose with adjuvant
Treatment: Other - LYB005 high dose with adjuvant
Treatment: Other - Placebo
Treatment: Other - Positive control

Experimental: Group 1 (LYB005 low dose without adjuvant; young adults) - Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30µg) without adjuvant on Day 1.

Experimental: Group 2 (LYB005 middle dose without adjuvant; young adults) - Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60µg) without adjuvant on Day 1.

Experimental: Group 3 (LYB005 high dose without adjuvant; young adults) - Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120µg) without adjuvant on Day 1.

Experimental: Group 4 (LYB005 low dose with adjuvant; young adults) - Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30µg) with adjuvant on Day 1.

Experimental: Group 5 (LYB005 middle dose with adjuvant; young adults) - Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60µg) with adjuvant on Day 1.

Experimental: Group 6 (LYB005 high dose with adjuvant; young adults) - Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120µg) with adjuvant on Day 1.

Placebo comparator: Group 7 (placebo; young adults) - Young adults (18-59 years old) will receive a single injection of placebo on Day 1.

Experimental: Group 8 (LYB005 low dose without adjuvant; older adults) - Older adults (=60 years old) will receive a single injection of low dose LYB005 (30µg) without adjuvant on Day 1.

Experimental: Group 9 (LYB005 middle dose without adjuvant; older adults) - Older adults (=60 years old) will receive a single injection of middle dose LYB005 (60µg) without adjuvant on Day 1.

Experimental: Group 10 (LYB005 high dose without adjuvant; older adults) - Older adults (=60 years old) will receive a single injection of high dose LYB005 (120µg) without adjuvant on Day 1.

Experimental: Group 11 (LYB005 low dose with adjuvant; older adults) - Older adults (=60 years old) will receive a single injection of low dose LYB005 (30µg) with adjuvant on Day 1.

Experimental: Group 12 (LYB005 middle dose with adjuvant; older adults) - Older adults (=60 years old) will receive a single injection of middle dose LYB005 (60µg) with adjuvant on Day 1.

Experimental: Group 13 (LYB005 high dose with adjuvant; older adults) - Older adults (=60 years old) will receive a single injection of high dose LYB005 (120µg) with adjuvant on Day 1.

Active comparator: Group 14 (AREXVY; older adults) - Older adults (=60 years old) will receive a single injection of positive control AREXVY on Day 1.


Treatment: Other: LYB005 low dose without adjuvant
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

Treatment: Other: LYB005 middle dose without adjuvant
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

Treatment: Other: LYB005 high dose without adjuvant
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

Treatment: Other: LYB005 low dose with adjuvant
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

Treatment: Other: LYB005 middle dose with adjuvant
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

Treatment: Other: LYB005 high dose with adjuvant
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.

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

Treatment: Other: Positive control
AREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immediate AEs for 30 minutes post-vaccination
Timepoint [1] 0 0
30 mins after vaccination
Primary outcome [2] 0 0
Solicited local and systemic AEs and unsolicited AEs
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Unsolicited AEs
Timepoint [3] 0 0
Within 28 days after vaccination
Primary outcome [4] 0 0
Clinically significant laboratory abnormalities
Timepoint [4] 0 0
Day 4, Day 8, Day 29 and Day 91
Primary outcome [5] 0 0
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
Timepoint [5] 0 0
Within 6 months after the vaccination
Secondary outcome [1] 0 0
To observe the humoral immunity (antibodies level) of LYB005 vaccine
Timepoint [1] 0 0
Day 15 and Day 29
Secondary outcome [2] 0 0
To observe the persistence of humoral immunity (antibodies level) of LYB005 vaccine
Timepoint [2] 0 0
Day 91 and Day 181
Secondary outcome [3] 0 0
To observe the humoral immunity (increase in antibodies level) of LYB005 vaccine
Timepoint [3] 0 0
Day 15 and Day 29
Secondary outcome [4] 0 0
To observe the persistence of humoral immunity (increase in antibodies level) of LYB005 vaccine
Timepoint [4] 0 0
Day 91 and Day 181

Eligibility
Key inclusion criteria
1. 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.
2. Written informed consent obtained from the subject before any assessment is performed.
3. 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).
4. Subjects must have a Body Mass Index (BMI) between =18.0 and =35.0 kg/m^2 at screening.
5. 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.
6. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Tympanic temperature > 37.5°C at screening or prior to vaccination.
2. History or presence of any respiratory infection symptoms within 7 days prior to vaccination.
3. 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.
4. Received a live attenuated vaccine within 28 days before vaccination or received other vaccines within 14 days before vaccination.
5. Received any immunoglobulins or blood/plasma products within 3 months prior to vaccination.
6. 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.
7. Clinically significant laboratory abnormalities determined by the investigator at screening.
8. A positive urine drug test or alcohol breath test at screening or Day 1.
9. 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.
10. Have donated blood or plasma within 2 weeks prior to screening.
11. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Guangzhou Patronus Biotech Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Yantai Patronus Biotech Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christina Chang, M.D
Address 0 0
Nucleus Network Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06442241