Acute respiratory infection.
Conditions
Interventions
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Study participants aged 18 and above, male or female; 2. The study participant voluntarily participates in the trial, signs the informed consent form, and can provide valid identification to understand and comply with the requirements of the trial protocol; 3. Axillary body temperature < 37.3°C on the day of enrollment; 4. Female study participants of childbearing potential should take effective contraceptive measures within 1 month before enrollment; Women of childbearing potential (except for women who have had tubal sterilization, bilateral oophorectomy, or hysterectomy) and male study participants who have used effective contraception from the screening period to 12 months after vaccination and have avoided pregnancy plans, sperm donation/egg donation plans, effective contraceptives include oral contraceptives (excluding emergency contraceptives), injectable or implanted contraception, extended-release topical contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the trial vaccine or its excipients, or history of anaphylactic shock or other serious adverse reactions to other vaccines; 2. Vaccinated with respiratory syncytial virus vaccine before enrollment; 3. History of RSV-related respiratory tract infection (confirmed by RT-PCR) within 12 months before enrollment; 4. Have taken antipyretic, analgesic or anti-allergic drugs within 24 hours before enrollment; 5. Vaccination with live vaccines within 28 days before vaccination, or vaccination with other types of vaccines other than live vaccines within 14 days; 6. Received blood or blood-related products, including immunoglobulin, within 3 months before enrollment; or planned use during the trial; 7. Those with the following diseases: (1) Acute onset of various acute diseases or chronic diseases in the past 3 days; (2) Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; (3) History of congenital or acquired immunodeficiency or autoimmune disease; (4) Long-term use (continuous use >14 days) of glucocorticoids (dose >=20mg/day prednisone or equivalent) or other immunosuppressants in the past 3 months, but the following conditions are allowed to enroll: inhaled or topical use of topical steroids, or short-term use (course of treatment =160mmHg and/or diastolic blood pressure >=100mmHg when measured on-site); 8. History of major surgery within 12 weeks prior to enrollment (according to the investigator's judgment), or has not fully recovered from surgery, or the study participant expects to have major surgery planned during the trial period; 9. Long-term history of alcohol and/or drug abuse; 10. Those who are participating in or plan to participate in other clinical trials; 11. Study participant in the opinion of the investigator: Presence of any disease or condition that may put the study participant at unacceptable risk, unable to meet protocol requirements, interfere with the evaluation of the vaccine; 12. Exclusion criteria for some populations: lactating women or pregnant women during the clinical trial, or women of childbearing age have a positive pregnancy test before vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AE) within 30 minutes after vaccination.;Cytokine levels (measured by ELISPOT method): Th1 type - IFN-?, Th2 type - IL-4.;Incidence and severity of solicited local and systemic AE within 7 days after vaccination.;Incidence of clinically significant abnormal laboratory test results within 3 days after vaccination.;Incidence and severity of unsolicited AE within 28 days after vaccination.;Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after vaccination.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titers (GMT) and geometric mean fold rise (GMFR) of RSV - A and RSV - B neutralizing antibodies in serum ;Geometric mean concentration (GMC) and GMFR of RSV pre - fusion F protein - binding antibodies in serum ; | — |
Countries
China
Contacts
Public ContactBeifang Yang
Hubei Provincial Center for Disease Prevention and Control
Outcome results
None listed