Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV)
Conditions
Interventions
BW-201 (Adj 1) low dose group:This product is administered once, 60ug. The antigen and adjuvant must be mixed prior to administration. The adjuvant vial should be inverted 5 to 10 times to mix thoroug
BW-201 (Adj 1) high dose group:This product is administered once, 120ug. The antigen and adjuvant must be mixed prior to administration. The adjuvant vial should be inverted 5 to 10 times to mix thoro
Sodium Chloride Injection group:Each subject will receive 0.5 mL via intramuscular injection into the deltoid muscle of the upper arm
intravenous injection is strictly prohibited.
Sponsors
Hebei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Willingness to participate in this clinical trial, the ability to fully understand and voluntarily sign the informed consent form (ICF), and the ability to comply with the requirements and restrictions outlined in the ICF. 2. Adult male or female participants aged 18 to 59 years, or >= 60 years, at the time of enrollment. 3. Healthy adults who, based on medical history, vital signs, physical examination, laboratory tests (*), and electrocardiogram (*), are determined by the investigator to be normal or have abnormalities of no clinical significance, and are eligible for inclusion in the study. (Note: Healthy participants with stable pre-existing conditions are allowed to be enrolled in the study. Stable pre-existing conditions are defined as conditions that have not worsened in the 6 weeks prior to enrollment and do not require significant changes in treatment or hospitalization.) 4. Willing and able to cooperate with the investigators, and to comply with and complete the scheduled visits, immunization, laboratory tests, and other study procedures as required by the protocol. 5. Female participants of childbearing potential (WOCBP, as defined in Appendix 1) must have a negative urine pregnancy test at the time of enrollment and must use effective contraception (as defined in Appendix 1) from the time of signing the ICF until 3 months after receiving the study vaccine.
Exclusion criteria
Exclusion criteria: 1. *Fever (axillary temperature >= 37.3°C) on the day of vaccination or within 72 hours prior to vaccination with the investigational vaccine. 2. *Acute illness or acute exacerbation of a chronic illness, or the use of antipyretic, analgesic, or anti-allergic medications within 72 hours prior to vaccination with the investigational vaccine. 3. Previous vaccination with any RSV vaccine or planned vaccination with any RSV vaccine other than the investigational product. 4. History of RSV infection within the past 6 months prior to vaccination, based on medical history. 5. Body mass index (BMI) 32.5 kg/m². 6. Hypertension measured by physical examination (18-59 years: systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg; >= 60 years: systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg). 7. History of severe allergic reactions to any component of the investigational vaccine, or a history of severe allergic reactions to previous vaccines, such as anaphylactic shock, severe urticaria, dyspnea, allergic laryngeal edema, angioedema, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reactions (Arthus reactions); history of Guillain-Barré syndrome following previous vaccination. 8. *Use of immunosuppressive or other immune-modulating drugs (e.g., corticosteroids: prednisone or equivalent at >= 2 mg/kg/day or >= 20 mg/day) for >= 14 consecutive days within the past 6 months prior to vaccination, except for localized treatments (e.g., ointments, eye drops, inhalers, or nasal sprays), which must not exceed the recommended dose or show signs of systemic exposure. 9. Known medical history or diagnosed conditions that affect immune system function, including but not limited to: cancer (except for basal cell carcinoma of the skin), congenital or acquired immunodeficiency (e.g., HIV infection), autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis), asplenia or functional asplenia. 10. Severe or uncontrolled respiratory diseases, thyroid disease, cardiovascular diseases, neurological disorders, psychiatric disorders, hematologic and lymphatic diseases, liver and kidney diseases, metabolic or skeletal disorders, or any other condition that, in the investigator's judgment, may affect the study protocol or outcomes. 11. History of bleeding disorders or coagulopathy (e.g., cytokine deficiencies, coagulation disorders, or platelet dysfunction), or history of severe bleeding, or significant bleeding after intramuscular injection or venipuncture. 12. History of or current infection with hepatitis B, hepatitis C, or syphilis. 13. *Receipt of or planned receipt of live attenuated vaccines within 30 days prior to vaccination or within 30 days after vaccination with the investigational vaccine, or receipt of or planned receipt of any vaccine (other than the investigational vaccine) within 14 days prior to vaccination or within 14 days after vaccination. 14. *Use or planned use of any investigational or unapproved drugs or vaccines within 30 days prior to vaccination (or within 5 half-lives of the investigational drug), or during the study. 15. *Planned use of immunoglobulins and/or blood products within 3 months prior to vaccination or during the study period. 16. History of alcohol abuse or alcohol dependence (e.g., inability to control drinking behavior, dependence on alcohol) or drug abuse. 17. Pregnant or breastfeeding women, or women planning to donate e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, type, and severity of solicited adverse events (AEs) within 14 days after vaccination.;Incidence, type, and severity of unsolicited AEs within 30 days after vaccination.;Incidence, type, and severity of Adverse Events of Special Interest (AESIs) within 30 days after vaccination.;Incidence, type, and severity of Serious Adverse Events (SAEs) within 30 days after vaccination.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Titers of neutralizing antibodies against RSV A and RSV B before vaccination and 14 and 30 days after vaccination.;Concentrations of RSV A and B subtype-specific IgG antibodies against the BW-201 antigen (RSV pre-fusion F protein, preF) before vaccination and 14 and 30 days after vaccination.;Levels of BW-201 antigen (preF)-specific T cells secreting IFN-? (Elispot method) before vaccination and 14 days after vaccination.;Frequency of IFN-?-positive, IL-2-positive, and dual-positive (IFN-? and IL-2) CD4+ T cells in response to BW-201 antigen (preF) by intracellular cytokine staining (ICS method) before vaccination and 14 days after vaccination.;Changes in laboratory test results on Day 3 after vaccination.;Incidence of SAEs/AESIs within 12 months after vaccination.; | — |
Countries
China
Contacts
Public ContactFei Jin
Hebei Provincial Center for Disease Control and Prevention
Outcome results
None listed