A Study to Evaluate the Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
NCT ID: NCT07208461
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
700 participants
INTERVENTIONAL
2025-10-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Low dose antigen of LYB005 without A01B adjuvant
Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen without A01B adjuvant) at Day 0.
Low dose antigen of LYB005 without A01B adjuvant
0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.
Low dose antigen of LYB005 with A01B adjuvant
Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 (low dose antigen with A01B adjuvant) at Day 0.
Low dose antigen of LYB005 with A01B adjuvant
0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.
Middle dose antigen of LYB005 without A01B adjuvant
Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen without A01B adjuvant) at Day 0.
Middle dose antigen of LYB005 without A01B adjuvant
0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.
Middle dose antigen of LYB005 with A01B adjuvant
Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 (middle dose antigen with A01B adjuvant) at Day 0.
Middle dose antigen of LYB005 with A01B adjuvant
0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.
High dose antigen of LYB005 without A01B adjuvant
Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen without A01B adjuvant) at Day 0.
High dose antigen of LYB005 without A01B adjuvant
0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.
High dose antigen of LYB005 with A01B adjuvant
Participant aged 60 years and older will be vaccinated with 1 dose of LYB005 (high dose antigen with A01B adjuvant) at Day 0.
High dose antigen of LYB005 with A01B adjuvant
0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.
Placebo
Participants aged 60 years and older will be vaccinated with 1 dose of placebo at Day 0.
Placebo
0.5 mL 0.9% sodium chloride (normal saline) injection per dose
Interventions
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Low dose antigen of LYB005 without A01B adjuvant
0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.
Low dose antigen of LYB005 with A01B adjuvant
0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.
Middle dose antigen of LYB005 without A01B adjuvant
0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.
Middle dose antigen of LYB005 with A01B adjuvant
0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.
High dose antigen of LYB005 without A01B adjuvant
0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.
High dose antigen of LYB005 with A01B adjuvant
0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.
Placebo
0.5 mL 0.9% sodium chloride (normal saline) injection per dose
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. Axillary temperature \< 37.3°C on the day of enrollment;
4. 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.
Exclusion Criteria
2. Previous vaccination against Respiratory Syncytial Virus;
3. A confirmed diagnosis or etiological evidence of respiratory syncytial virus infection and related diseases caused by the infection within 12 months before enrollment;
4. Has taken antipyretics, analgesics or anti-allergy drugs within 24 hours before enrollment;
5. Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;
6. Has received blood or blood-related products, including immunoglobulin, within 3 months prior to enrollment; or plan to use them during the study period;
7. 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);
8. 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;
9. History of long-term alcohol abuse and/or drug abuse;
10. 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;
11. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.
60 Years
ALL
Yes
Sponsors
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Guangzhou Patronus Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yeqing Tong
Role: PRINCIPAL_INVESTIGATOR
Hubei Provincial Center for Disease Control and Prevention
Locations
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Center for Disease Control and Prevention of Dangyang City
Dangyang, , China
Countries
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Other Identifiers
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LYB005/CT-CHN-201
Identifier Type: -
Identifier Source: org_study_id
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