Lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV)
Conditions
Interventions
Adults aged 18-59 years in low-dose group:One dose of SAX201 or placebo on Day 0
Low dose: 7.0 lg FFU
Adults aged 18-59 years in high-dose group:One dose of SAX201 or placebo on Day 0
High dose: 8.0 lg FFU
Adults aged 60 years and older in low-dose group:One dose of SAX201 or placebo on Day 0
Low dose: 7.0 lg FFU
Adults aged 60 years and older in high-dose group:One dose of SAX201 or placebo on Day 0
High dose: 8.0 lg FFU
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The participant is aged 18 years or older on the day of enrollment, male or female. 2. The participant voluntarily agrees to take part in the trial, signs the informed consent form, is able to provide valid identification, and understands and complies with the protocol requirements. If the participant has close contacts and/or pets, the participant must assist the study team in obtaining information on respiratory disease–related symptoms and signs in those close contacts and/or pets. 3. Axillary temperature <=37.0°C prior to vaccination. 4. The participant must be determined by the investigator to be in good general health based on medical history, physical examination findings, and relevant laboratory test results. 5. For women of childbearing potential, a negative pregnancy test prior to vaccination and not pregnant or breastfeeding. For women of childbearing potential, or for male participants whose spouse/sexual partner is of childbearing potential: no sexual intercourse within 2 weeks prior to study participation through vaccination, or effective contraception used during that period; from signing the informed consent form until 6 months after vaccination, abstinence or effective contraception must be used, and there must be no plans for pregnancy during the study period.
Exclusion criteria
Exclusion criteria: 1) Previous receipt of any RSV vaccine, any PIV5-vectored vaccine, or any RSV monoclonal antibody (including investigational products), or plans to receive such products during the study. 2) History of RSV infection within 6 months prior to vaccination. 3) History of severe allergic reactions, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local necrotic allergic reactions (Arthus reaction), or allergy to any component of the investigational vaccine. 4) Known or suspected uncontrolled serious diseases that may interfere with study evaluation, including but not limited to:Pulmonary diseases (e.g., chronic obstructive pulmonary disease, pulmonary embolism, asthma), Cardiovascular diseases (e.g., uncontrolled hypertension, malignant arrhythmia, heart failure), Hepatic or renal diseases (e.g., chronic kidney disease requiring dialysis, liver cirrhosis), Metabolic diseases (e.g., poorly controlled diabetes), Hematologic and lymphatic system diseases (e.g., sickle cell anemia; lymphadenitis, lymph node adhesion, lymph node tuberculosis, tumor metastasis, skin scars or fistulae at lymph node sites; or lymphadenopathy, tenderness, or redness/swelling over lymph nodes identified within 7 days prior to vaccination), Malignancy that is active, inadequately treated, or carries a risk of recurrence during the study period. 5) Asplenia or functional asplenia. 6) History of autoimmune disease (including Guillain–Barré syndrome); congenital or acquired immunodeficiency in the participant, or immunodeficiency in close contacts. This may include, but is not limited to: organ or bone marrow transplantation, HIV infection, chemotherapy within 12 months prior to vaccination, or systemic immunomodulatory therapy for =14 days within 3 months prior to vaccination. 7) History or family history of neurological disorders (e.g., convulsions, epilepsy, encephalopathy), history of neurological sequelae following infection or vaccination; history or family history of psychiatric disorders. 8) Contraindications to venipuncture, such as prior syncope with blood draws, coagulation disorders, thrombotic or bleeding disorders, or the need for continuous anticoagulant therapy. 9) Any acute illness within 14 days prior to vaccination or acute exacerbation of chronic disease, especially with a history and/or symptoms of upper or lower respiratory tract infection (e.g., cough, sore throat, fever, nasal congestion, dyspnea, tachypnea, wheezing, fatigue, myalgia). 10) Any clinically significant allergic rhinitis, postnasal drip, history of severe epistaxis, chronic sinus infection, or significant abnormalities altering nasal anatomy. 11) Anticipated use of nasal wash from enrollment through 30 days after study vaccination. 12) Receipt or anticipated receipt of any intranasal medications, including Ayurvedic oils or other naturopathic substances, from 7 days before vaccination through 30 days after vaccination. 13) Seropositive for Hepatitis C infection or HIV, or serologic evidence suggestive of current hepatitis B virus infection (based on virologic testing at screening). 14) Current smoking =5 cigarettes/day or =150 cigarettes/month, use of e-cigarettes, or a history of regular smoking or e-cigarette use within the past 2 years; alcohol abuse or dependence, defined as a pattern of drinking that results in significant mental or physical health problems and, in the investigator’s judgment, may prevent accurate safety reporti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) related to the study vaccine within 30 days after a single dose of SAX201; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity; | — |
Countries
China
Contacts
Public ContactDan Zhang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed