Respiratory Syncytial Virus (RSV)Phase 1NCT06442241
A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine, LYB005 in Healthy Adults
A Phase 1 study testing LYB005 low dose without adjuvant, LYB005 middle dose without adjuvant and LYB005 high dose without adjuvant in people with Respiratory Syncytial Virus (RSV) and RSV Infection, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), RSV Infection
- What is being tested?
- LYB005 low dose without adjuvant, LYB005 middle dose without adjuvant and LYB005 high dose without adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Jul 2024to 30 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- LYB005 low dose without adjuvant, LYB005 middle dose without adjuvant, LYB005 high dose without adjuvant, LYB005 low dose with adjuvant, LYB005 middle dose with adjuvant
- Keywords
- RSV vaccine, Virus Like Particle
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYB005 low dose without adjuvantBiological
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
LYB005 middle dose without adjuvantBiological
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
LYB005 high dose without adjuvantBiological
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
LYB005 low dose with adjuvantBiological
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
LYB005 middle dose with adjuvantBiological
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
LYB005 high dose with adjuvantBiological
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
PlaceboBiological
0.9% sodium chloride injection. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Positive controlBiological
AREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (LYB005 low dose without adjuvant; young adults) | Experimental | Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1. Receives: Biological: LYB005 low dose without adjuvant |
| Group 2 (LYB005 middle dose without adjuvant; young adults) | Experimental | Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1. Receives: Biological: LYB005 middle dose without adjuvant |
| Group 3 (LYB005 high dose without adjuvant; young adults) | Experimental | Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1. Receives: Biological: LYB005 high dose without adjuvant |
| Group 4 (LYB005 low dose with adjuvant; young adults) | Experimental | Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1. Receives: Biological: LYB005 low dose with adjuvant |
| Group 5 (LYB005 middle dose with adjuvant; young adults) | Experimental | Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1. Receives: Biological: LYB005 middle dose with adjuvant |
| Group 6 (LYB005 high dose with adjuvant; young adults) | Experimental | Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1. Receives: Biological: LYB005 high dose with adjuvant |
| Group 7 (placebo; young adults) | Placebo comparator | Young adults (18-59 years old) will receive a single injection of placebo on Day 1. Receives: Biological: Placebo |
| Group 8 (LYB005 low dose without adjuvant; older adults) | Experimental | Older adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1. Receives: Biological: LYB005 low dose without adjuvant |
| Group 9 (LYB005 middle dose without adjuvant; older adults) | Experimental | Older adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1. Receives: Biological: LYB005 middle dose without adjuvant |
| Group 10 (LYB005 high dose without adjuvant; older adults) | Experimental | Older adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1. Receives: Biological: LYB005 high dose without adjuvant |
| Group 11 (LYB005 low dose with adjuvant; older adults) | Experimental | Older adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1. Receives: Biological: LYB005 low dose with adjuvant |
| Group 12 (LYB005 middle dose with adjuvant; older adults) | Experimental | Older adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1. Receives: Biological: LYB005 middle dose with adjuvant |
| Group 13 (LYB005 high dose with adjuvant; older adults) | Experimental | Older adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1. Receives: Biological: LYB005 high dose with adjuvant |
| Group 14 (AREXVY; older adults) | Active comparator | Older adults (≥60 years old) will receive a single injection of positive control AREXVY on Day 1. Receives: Biological: Positive control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate AEs for 30 minutes post-vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after the vaccination
Measured: 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
Measured: Within 7 days after vaccination
Unsolicited AEs
The incidence and severity of any unsolicited AEs within 28 days after the vaccination
Measured: 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
Measured: 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
Measured: Within 6 months after the vaccination
Secondary outcomes (4)
To observe the humoral immunity (antibodies level) of LYB005 vaccine
The geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies at 14 days and 28 days after the vaccination; the geometric mean concentration (GMC) of RSV PreF antibodies at 14 days and 28 days after the vaccination.
Measured: Day 15 and Day 29
To observe the persistence of humoral immunity (antibodies level) of LYB005 vaccine
The GMT of RSV A and RSV B neutralizing antibodies at 3 and 6 months after the vaccination; the GMC of RSV PreF antibodies at 3 and 6 months after the vaccination
Measured: Day 91 and Day 181
To observe the humoral immunity (increase in antibodies level) of LYB005 vaccine
The geometric mean fold rise (GMFR) of RSV A and RSV B neutralizing antibodies at 14 days and 28 days after the vaccination; the GMFR of RSV PreF antibodies at 14 days and 28 days after the vaccination.
Measured: Day 15 and Day 29
To observe the persistence of humoral immunity (increase in antibodies level) of LYB005 vaccine
The GMFR of RSV A and RSV B neutralizing antibodies at 3 and 6 months after the vaccination; the GMFR of RSV PreF antibodies at 3 and 6 months after the vaccination
Measured: Day 91 and Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start31 Jul 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Christina Chang, M.D, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442241
- Sponsor's protocol ID
- LYB005-CT-AUS-101
- Status last verified
- Mar 2025
- First submitted
- 28 May 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06442241
- Acronym / sponsor ID
- LYB005-CT-AUS-101
- Conditions
- Respiratory Syncytial Virus (RSV), RSV Infection
- Keywords
- RSV vaccine, Virus Like Particle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Guangzhou Patronus Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yantai Patronus Biotech Co., Ltd.
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Group 1 (LYB005 low dose without adjuvant; young adults) | Experimental | Biological: LYB005 low dose without adjuvantYoung 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) | Experimental | Biological: LYB005 middle dose without adjuvantYoung 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) | Experimental | Biological: LYB005 high dose without adjuvantYoung 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) | Experimental | Biological: LYB005 low dose with adjuvantYoung 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) | Experimental | Biological: LYB005 middle dose with adjuvantYoung 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) | Experimental | Biological: LYB005 high dose with adjuvantYoung 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 comparator | Biological: PlaceboYoung adults (18-59 years old) will receive a single injection of placebo on Day 1. |
| Group 8 (LYB005 low dose without adjuvant; older adults) | Experimental | Biological: LYB005 low dose without adjuvantOlder 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) | Experimental | Biological: LYB005 middle dose without adjuvantOlder 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) | Experimental | Biological: LYB005 high dose without adjuvantOlder 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) | Experimental | Biological: LYB005 low dose with adjuvantOlder 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) | Experimental | Biological: LYB005 middle dose with adjuvantOlder 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) | Experimental | Biological: LYB005 high dose with adjuvantOlder 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 comparator | Biological: Positive controlOlder adults (≥60 years old) will receive a single injection of positive control AREXVY on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYB005 low dose without adjuvantDosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 1 (LYB005 low dose without adjuvant; young adults), Group 8 (LYB005 low dose without adjuvant; older adults) |
| LYB005 middle dose without adjuvantDosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 2 (LYB005 middle dose without adjuvant; young adults), Group 9 (LYB005 middle dose without adjuvant; older adults) |
| LYB005 high dose without adjuvantDosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 10 (LYB005 high dose without adjuvant; older adults), Group 3 (LYB005 high dose without adjuvant; young adults) |
| LYB005 low dose with adjuvantDosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 11 (LYB005 low dose with adjuvant; older adults), Group 4 (LYB005 low dose with adjuvant; young adults) |
| LYB005 middle dose with adjuvantDosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 12 (LYB005 middle dose with adjuvant; older adults), Group 5 (LYB005 middle dose with adjuvant; young adults) |
| LYB005 high dose with adjuvantDosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 13 (LYB005 high dose with adjuvant; older adults), Group 6 (LYB005 high dose with adjuvant; young adults) |
| Placebo0.9% sodium chloride injection. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 7 (placebo; young adults) |
| Positive controlAREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. | Biological | Group 14 (AREXVY; older adults) |
Primary outcome
Immediate AEs for 30 minutes post-vaccination
Time frame: 30 mins after vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after the vaccination
Solicited local and systemic AEs and unsolicited AEs
Time frame: Within 7 days after vaccination
The incidence and severity of any solicited local and systemic AEs and unsolicited AEs within 7 days after the vaccination
Unsolicited AEs
Time frame: Within 28 days after vaccination
The incidence and severity of any unsolicited AEs within 28 days after the vaccination
Clinically significant laboratory abnormalities
Time frame: Day 4, Day 8, Day 29 and Day 91
The occurrence of clinically significant laboratory abnormalities 3 days, 7 days, 28 days and 90 days after vaccination
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: Within 6 months after the vaccination
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) within 6 months after the vaccination
4 secondary outcomes
To observe the humoral immunity (antibodies level) of LYB005 vaccine
Time frame: Day 15 and Day 29
To observe the persistence of humoral immunity (antibodies level) of LYB005 vaccine
Time frame: Day 91 and Day 181
To observe the humoral immunity (increase in antibodies level) of LYB005 vaccine
Time frame: Day 15 and Day 29
To observe the persistence of humoral immunity (increase in antibodies level) of LYB005 vaccine
Time frame: Day 91 and Day 181
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Chang, M.D principal investigator
Nucleus Network Pty Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYB005 low dose without adjuvant, LYB005 middle dose without adjuvant and LYB005 high dose without adjuvant in people with Respiratory Syncytial Virus (RSV) and RSV Infection, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate AEs for 30 minutes post-vaccination (time frame: 30 mins after vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.