Acute respiratory infection.
Conditions
Interventions
Placebo control group:Administer 0.5 ml of sodium chloride injection, with an immunization schedule starting from day 0.
Low-dose group:Administer 0.25 ml of 50µg recombinant respiratory syncytial virus vaccine (CHO cells), with an immunization schedule starting from day 0.
High-dose group:Administer 0.5 ml of 100µg recombinant respiratory syncytial virus vaccine (CHO cells), with an immunization schedule starting from day 0.
Sponsors
Hubei Provincial Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Research participants aged 18 - 59 or >= 60 years old, either male or female; 2.The research participants themselves voluntarily participate in the trial, sign the informed consent form, are able to provide valid identification, and understand and comply with the requirements of the trial protocol; 3.The body mass index (BMI) of the research participants is between 18 - 32 kg/m^2 (including the boundary values); 4.Female research participants of childbearing age (including those in perimenopause) have taken effective contraceptive measures within 2 weeks before participating in this trial, and the result of the pregnancy test before vaccination is negative. Male and female research participants of childbearing age (including those in perimenopause) voluntarily agree to take effective contraceptive measures from the time of signing the informed consent form until 6 months after vaccination. [Effective contraceptive measures include: oral contraceptives (excluding emergency contraceptives), injection or implant contraceptives, slow-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms (for men), contraceptive diaphragms, cervical caps, etc.].
Exclusion criteria
Exclusion criteria: 1.Those with abnormal results in laboratory examination indexes, 12-lead electrocardiogram, vital signs and physical examination during the screening period, and whose abnormalities are judged by clinicians to be clinically significant; 2.Those who are suspected or diagnosed with fever (axillary body temperature >= 37.3 °C) within 72 hours before enrollment; 3.Those who have been previously laboratory-confirmed as infected with RSV; 4.Those with systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 5.Those who are known to be allergic to the vaccine for trial use or its excipients, or who have a history of severe allergies to other vaccines, foods, drugs, etc. in the past (including but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, etc.); 6.Research participants who have been vaccinated with inactivated vaccines, subunit vaccines or recombinant vaccines within 14 days before enrollment, or who have been vaccinated with any live vaccines within 28 days before being selected for the trial; or those who plan to be vaccinated with other vaccines within 28 days after vaccination; 7.Those who have taken antipyretic, analgesic or anti-allergic drugs, etc. within 24 hours before enrollment; 8.Those who have used glucocorticoids (a dose >= 20 mg/day of prednisone or an equivalent dose) or other immunosuppressants for a long time (continuous use > 14 days) in the past 6 months, but enrollment is allowed in the following circumstances: inhalation or topical use of external steroids, or short-term use (course of treatment <= 14 days) of oral steroids; 9.Those who have received blood or blood-related products (including immunoglobulin) within 3 months before enrollment, or who have a planned use during the trial period; 10.Those suffering from the following diseases (obtained through inquiry and/or relevant diagnosis): ? Those who have suffered from any acute disease or are in the acute exacerbation period of a chronic disease within 7 days before enrollment; ? Those with a history of congenital or acquired immunodeficiency or autoimmune diseases (including but not limited to Guillain-Barré syndrome, type I diabetes and autoimmune hemolysis, etc.); ? Those who are known to be diagnosed with or currently suffering from infectious diseases, including hepatitis B, hepatitis C, syphilis or AIDS, etc.; ? Those with neurological diseases or a family history (convulsions, epilepsy, encephalopathy, etc.), and those with a history of neurological sequelae after infection or vaccination; those with a history of mental illness or a family history; ? Those without a spleen, or with functional asplenia; ? Those currently suffering from severe or uncontrollable or requiring hospitalization for treatment of cardiovascular system diseases (including but not limited to congestive heart failure, coronary artery disease and cerebrovascular accident), diabetes, respiratory system diseases (such as chronic obstructive pulmonary disease), blood and lymphatic system diseases, immune system diseases, liver and kidney diseases (such as end-stage renal disease), metabolic and skeletal system diseases, or malignant tumors; ? Those with contraindications for intramuscular injection and blood sampling, such as coagulation disorders, thrombotic or hemorrhagic diseases, or situations requiring continuous use of anticoagulants; 11.Female rese
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited local/systemic adverse events (AE) within 0 - 14 days after vaccination.;Non-solicited adverse events (AE) within 0-28 days after vaccination;Solicited local/systemic adverse events (AE) within 30 minutes after vaccination.;Laboratory safety observation indicators (including blood routine, blood biochemistry, coagulation function, and urine routine, etc.) on the 4th day after vaccination, and the changes in electrocardio;All serious adverse events (SAEs), adverse events of special interest (AESIs), and adverse events (AEs) leading to withdrawal during the trial period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentration (GMC), geometric mean fold rise (GMFR) and seroconversion rate (SCR) of RSV Pre-F IgG antibodies [before vaccination, on Day 14 and Day 28 after vaccination, and at Month;Levels of antigen-specific T cell responses secreting IFN-?, IL-2 and IL-4 [before vaccination, on Day 14 after vaccination];Geometric mean titer (GMT), geometric mean fold rise (GMFR), and seroconversion rate (SCR) of neutralizing antibodies against respiratory syncytial virus (RSV) subtype A and subtype B [before vacci; | — |
Countries
China
Contacts
Public ContactBeifang Yang
Hubei Provincial Center for Disease Prevention and Control
Outcome results
None listed