Respiratory Syncytial Virus infection
Conditions
Interventions
low dose (single vaccination):Day 0 low dose
low dose (two vaccinations):Day 0/14 low dose
high dose (single vaccination):Day 0 high dose
high dose (two vaccinations):Day 0/14 high dose
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Be 18 years of age and older. Obtain informed consent from the subject and sign the informed consent form. Subject is able and willing to comply with the requirements of the clinical trial protocol, and is willing and able to comply with all study plan components and other requirements of the study. Women who are non-pregnant (negative pregnancy test results) and non-lactating. Female subjects of childbearing potential (WOCBP) who were using effective contraception 1 month prior to enrolment. WOCBP subjects and male subjects who do not plan to become pregnant from Screening to 6 months after the last dose of immunization and agree to use effective contraception from the Screening Visit to 6 months after the last dose of immunization. [WOCBP subjects and male subjects agree not to donate eggs (oocytes, oocytes) for assisted reproduction (for WOCBP subjects) or to refrain from sperm donation (for male subjects) from the Screening Visit until 6 months after the last dose of immunization. Healthy adults eligible for enrolment in this study as determined by medical history, physical examination, vital signs, laboratory tests, and clinical judgement of the investigator.
Exclusion criteria
Exclusion criteria: Deviation from the normal range of laboratory markers (including blood counts and liver and kidney function) at the time of screening, which is judged by the investigator to be abnormal and clinically significant. Serious chronic disease, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, need for oxygen oxygenation, end-stage renal disease with or without dialysis, clinically unstable cardiovascular disease, Alzheimer's disease, or any disease, treatment, or laboratory test abnormality that, in the opinion of the Investigator, may interfere with subject participation in the study as a whole, increase the risk to the subject, or confound the results of the study, or Participation in the study is not, in the opinion of the Investigator, in the best interest of the subject. Subject has a history of malignancy within 5 years prior to screening (except squamous cell carcinoma of the skin, basal cell carcinoma, and carcinoma in situ of the cervix where the malignancy has been cured and the risk of recurrence is considered to be minimal). Subjects who have undergone surgical procedures or operations (at the investigator's discretion) within 4 weeks prior to randomisation or are scheduled to undergo surgical procedures or operations throughout the course of the study (at the investigator's discretion) that may interfere with the results of the study or have not yet been fully resuscitated. Absence of spleen or functional absence of spleen. Severe infection or other acute illness, including fever greater than 37.0°C °F (warm) on the day of randomisation to group. Suffering from more severe cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction; severe hypertension that is uncontrolled by medication (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg when measured at the site), etc.:Has been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia, or other autoimmune disease. Received antineoplastic drugs and immunomodulators or radiotherapy, such as anticancer chemotherapy or radiotherapy, during the study period and within 6 months prior to receiving the first dose of vaccine; or received long-term systemic corticosteroid therapy (prednisone or its equivalent for more than 2 weeks within the last 3 months). Subject has a history of acute polyneuropathy (e.g., Guillain-Barre syndrome). Nasal abnormalities that, in the judgement of the investigator, may interfere with specimen collection or vaccination, such as intranasal granulomas, deviated septum, nasal polyps, etc. Have received immune globulin or blood products within 3 months prior to receiving the trial vaccine or plan to receive such treatment during the study period. Have active tuberculosis and are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening. Subjects with acute sinusitis or acute rhinitis, or chronic sinusitis or chronic rhinitis with symptoms of acute exacerbation within 3 days prior to vaccination. Received any intranasal medication or nasal surgical treatment within 7 days prior to vaccination. Have donated blood within 4 months prior to the start of the trial or plan to donate blood during the study and for 12 weeks after completion of the study. Received any prophylactic or therapeutic RSV vaccine or RSV investigational drug within 28 days of receiving the trial va
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of solicited local and systemic adverse events (AEs) 0-7 days after each dose;;Incidence of adverse events (AE) and adverse reactions (AR) from 0 to 30 days after each dose.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of SAE and AESI 12 months after first to last dose.;GMT and GMI of anti-RSV serotypes A and B (ELISA) neutralizing antibodies at pre-immunization, day 14 , day 30, and month 3 after the last immunization.;GMT and GMI of anti-RSV Pre-F protein neutralizing antibodies at pre-immunization, day 14 , day 30, and month 3 after the last immunization.;sIgA antibody in nasal lavage fluid of subjects pre-immunization, the day14 and month 3.; | — |
Countries
China
Contacts
Public ContactHuashan Shi
West China Hospital of Sichuan University
Outcome results
None listed