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Tests treatment safety and results for Respiratory Syncytial Virus
Official title A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine
ClinicalTrials.gov ID: NCT06754605
What this study is testing
What is SCTV02?
SCTV02 is an investigational medicine, being studied as a potential treatment for respiratory syncytial virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120. Healthy volunteers may be eligible.
You may be able to join if
- Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the...
- Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and...
- Be able to complete the diary card, contact card and diary/contact card by own or with the assistance of others.
- Phase I: healthy people or healthy people judged by the investigator according to the clinical data of the people; Stage II: people who are healthy...
- Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after...
You likely can't join if
- Acute illness and/or fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic...
- Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.
- Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational...
- Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other glucocorticoids)...
- The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously...
- History or family history of epilepsy and mental illness.
See the full eligibility criteria
- Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the time of signing the ICF.
- Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.
- Be able to complete the diary card, contact card and diary/contact card by own or with the assistance of others.
- Phase I: healthy people or healthy people judged by the investigator according to the clinical data of the people; Stage II: people who are healthy or have a stable underlying disease.
- Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after immunization; Pregnancy test results for women of childbearing age during...
- Acute illness and/or fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic, analgesic, or antiallergic drugs.
- Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.
- Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine/product at any time during the study.
- Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior...
- The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously received the experimental respiratory syncytial virus (RSV) vaccine or been...
- History or family history of epilepsy and mental illness.
- A family history of congenital or hereditary immunodeficiency, or a history and physical examination confirmed or suspected immunosuppression or immunodeficiency, or human immunodeficiency virus (HIV) infection...
- Have the following organ-specific or systemic autoimmune diseases: Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's...
- Allergic to any component of the study vaccine, or any previous history of severe allergy to vaccine vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura...
- Severe chronic disease or active chronic disease, as assessed by the investigator, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, uncontrolled blood pressure after medication...
- Pregnant women (positive pregnancy test) or breastfeeding women, or those with pregnancy plans during the study period, or less than 6 weeks after the end of pregnancy (including ectopic pregnancy). Plan to donate eggs...
- Unable to follow the trial procedures, or plan to relocate or stay away for a long period of time during the study and cannot complete the trial follow-up.
- Any medical condition that makes intramuscular injection unsafe due to other abnormalities, conditions that may obfuscate the results of the study, or conditions that are not in the best interest of the subject, is...
The study team makes the final eligibility decision.
Where it's taking place
- Langfang, Hebei, China
- Luzhou, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Langfang, Hebei, China; Luzhou, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.