AzTrials
AzTrials

Respiratory Syncytial Virus Infection PreventionPhase 2NCT07208461

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older

A Phase 2 study testing Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant and Middle dose antigen of LYB005 without A01B adjuvant in people with Respiratory Syncytial Virus Infection Prevention, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a randomized, observer-blinded, placebo-controlled Phase Ⅱ clinical trial to evaluate the immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant and Middle dose antigen of LYB005 without A01B adjuvant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
700 participants
Where
1 siteChina
Study dates
21 Oct 2025to Dec 2026
Phase
Phase 2
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Residents aged 60 years and older (at the time of screening), regardless of gender;
  • Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form, and are able to attend all planned follow-up visits and comply with the protocol requirements;
  • Axillary temperature < 37.3°C on the day of enrollment;
  • Female participants must be postmenopausal (postmenopausal status defined as amenorrhea for 12 months without other medical causes) and must not intend to become pregnant by any means. Male participants must practice strict contraception and avoid plans for procreation or sperm donation from the screening period until 1 month after vaccination. Acceptable methods of contraception include oral contraceptives (excluding emergency contraception), injectable or implantable contraception, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, and cervical caps.

Who cannot join

  • Allergy to the investigational vaccine or its excipients, or a history of anaphylactic shock or other serious adverse reactions to other vaccines;
  • Previous vaccination against Respiratory Syncytial Virus;
  • A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment;
  • Has taken antipyretics, analgesics or anti-allergy drugs within 24 hours before enrollment;
  • Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
  • Has received blood or blood-related products, including immunoglobulin, within 3 months prior to enrollment; or plan to use them during the study period;
Show all 11Show fewer
  • Individual with the following diseases: ①Has acute diseases or are in the acute exacerbation period of chronic diseases within 3 days before vaccination; ②Diagnosed with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ③History of congenital or acquired immunodeficiency or autoimmune diseases; Chronic administration (≥14 consecutive days) of corticosteroids (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (<14 consecutive days) of oral corticosteroids; ④Neurological diseases or family history (seizures, epilepsy, encephalopathy, etc.); history of psychiatric disorders or family history; ⑤Asplenia or functional asplenia; ⑥Severe or uncontrolled or hospitalization-required cardiovascular diseases, diabetes, blood and lymphatic system diseases, immune system diseases, liver and kidney diseases, respiratory system diseases, metabolic and skeletal system diseases, or malignant tumors; ⑦Contraindications for intramuscular injection and blood drawing, such as coagulation disorders, thrombosis or hemorrhagic diseases, or situations requiring continuous use of anticoagulants; ⑧Severe hypertension that cannot be controlled by medication (measured on-site: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • History of major surgery within 12 weeks prior to enrollment (as determined by the investigator), or not fully recovered from the surgery, or having plans for major surgery during the anticipated period of the subject's participation in the study;
  • History of long-term alcohol abuse and/or drug abuse;
  • Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical study;
  • 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.

China1 site

  • Center for Disease Control and Prevention of Dangyang City

    Dangyang

Other trials in China

About this study

Official title: A Phase Ⅱ, Randomized, Observer-blinded, Placebo-Controlled Clinical Trial to Assess the Immunogenicity and Safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in Older Adults Aged 60 Years and Older

This is a randomized, observer-blinded, placebo-controlled Phase Ⅱ clinical trial to evaluate the immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.

Read the detailed description

A randomized, observer-blinded, placebo-controlled trial will be conducted to observe the immunogenicity and safety of LYB005 in adults aged 60 years and older. A total of 700 participants aged 60 years and older will be enrolled. Six formulations of LYB005 will be provided, three dose levels of antigen with or without A01B adjuvant. All participants will randomly receive six investigational vaccines and the placebo in a 1:1:1:1:1:1:1 ratio.

Being tested
Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant, Middle dose antigen of LYB005 without A01B adjuvant, Middle dose antigen of LYB005 with A01B adjuvant, High dose antigen of LYB005 without A01B adjuvant
Keywords
Respiratory Syncytial Virus, Respiratory Syncytial Virus Infection, Recombinant Respiratory Syncytial Virus (RSV) Vaccine
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.

  • Low dose antigen of LYB005 without A01B adjuvantBiological

    0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.

  • Low dose antigen of LYB005 with A01B adjuvantBiological

    0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.

  • Middle dose antigen of LYB005 without A01B adjuvantBiological

    0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.

  • Middle dose antigen of LYB005 with A01B adjuvantBiological

    0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.

  • High dose antigen of LYB005 without A01B adjuvantBiological

    0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.

  • High dose antigen of LYB005 with A01B adjuvantBiological

    0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.

  • PlaceboBiological

    0.5 mL 0.9% sodium chloride (normal saline) injection per dose

Study groups in NCT07208461
Study groupRoleWhat they receive
Low dose antigen of LYB005 without A01B adjuvantExperimentalParticipant aged 60 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen without A01B adjuvant) at Day 0.
Receives: Biological: Low dose antigen of LYB005 without A01B adjuvant
Low dose antigen of LYB005 with A01B adjuvantExperimentalParticipant aged 60 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen with A01B adjuvant) at Day 0.
Receives: Biological: Low dose antigen of LYB005 with A01B adjuvant
Middle dose antigen of LYB005 without A01B adjuvantExperimentalParticipant aged 60 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen without A01B adjuvant) at Day 0.
Receives: Biological: Middle dose antigen of LYB005 without A01B adjuvant
Middle dose antigen of LYB005 with A01B adjuvantExperimentalParticipant aged 60 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen with A01B adjuvant) at Day 0.
Receives: Biological: Middle dose antigen of LYB005 with A01B adjuvant
High dose antigen of LYB005 without A01B adjuvantExperimentalParticipant aged 60 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen without A01B adjuvant) at Day 0.
Receives: Biological: High dose antigen of LYB005 without A01B adjuvant
High dose antigen of LYB005 with A01B adjuvantExperimentalParticipant aged 60 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen with A01B adjuvant) at Day 0.
Receives: Biological: High dose antigen of LYB005 with A01B adjuvant
PlaceboPlacebo comparatorParticipants aged 60 years and older will be vaccinated with 1 dose of placebo at Day 0.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The geometric mean titer (GMT) of Neutralizing Antibodies Against RSV A and RSV B

    Measured by microneutralization assay.

    Measured: 30 days after vaccination

  2. Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B

    Change from prevaccination in geometric mean fold rise of Neutralizing antibody titer Against RSV A and RSV B

    Measured: 30 days after vaccination

Secondary outcomes (8)

  1. The GMT of Neutralizing Antibodies Against RSV A and RSV B

    Measured by microneutralization assay.

    Measured: 14 days, 3 months, 6 months and 12 months after vaccination after vaccination

  2. GMFR for Neutralizing Antibodies Against RSV A and RSV B

    Change from prevaccination in geometric mean fold rise of Neutralizing antibody titer Against RSV A and RSV B

    Measured: 14 days, 3 months, 6 months and 12 months after vaccination

  3. The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies

    Measured by Enzyme-Linked Immunosorbent Assay (ELISA).

    Measured: 30 days, 3 months, 6 months and 12 months after vaccination

  4. GMFR for Pre-fusion Protein Specific Binding Antibodies

    Change from prevaccination in geometric mean fold rise of Pre-fusion Protein Specific Binding Antibodies

    Measured: 30 days, 3 months, 6 months and 12 months after vaccination

  5. Occurrence of immediate adverse events

    The incidence and severity of any adverse events (AEs) within 30 minutes after vaccination

    Measured: Within 30 minutes after vaccination

  6. Incidence of solicited AE

    Occurrence and severity of solicited local injection site reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., pain, redness, swelling).

    Occurrence and severity of solicited systemic reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., myalgia, fatigue, headache, chills, fever).

    Measured: Within 0-7 days after vaccination

  7. Incidence of unsolicited AEs

    The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Day 0~30 after the vaccination.

    Measured: Within 0~30 days after vaccination

  8. Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)

    Incidence and severity of Serious adverse events and adverse events of special interest within 12 months after vaccination.

    Measured: 12 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2025
  2. Study start21 Oct 2025
  3. Primary completionMar 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07208461
Sponsor's protocol ID
LYB005/CT-CHN-201
Status last verified
Feb 2026
First submitted
27 Sep 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose antigen of LYB005 without A01B adjuvant, Low dose antigen of LYB005 with A01B adjuvant and Middle dose antigen of LYB005 without A01B adjuvant in people with Respiratory Syncytial Virus Infection Prevention, run by Guangzhou Patronus Biotech Co., Ltd. at 1 site in China.

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 4 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 11 Feb 2026. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The geometric mean titer (GMT) of Neutralizing Antibodies Against RSV A and RSV B (time frame: 30 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07208461.

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 11 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in