Evaluating a new vaccine for Respiratory Syncytial Virus
Official title: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults ≥18 Years of Age
Run by Sinocelltech Ltd. · NCT06754605 · Data updated 2026-11-12
This study is testing a new vaccine for Respiratory Syncytial Virus (RSV) in adults to see how safe it is and how well it helps the immune system.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Sinocelltech Ltd. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Langfang, Hebei and 1 other locations) |
| Status | Recruiting |
| Started | February 6, 2025 |
| Main results expected | July 30, 2027 |
| Study ends | July 30, 2027 |
| Registry record updated | February 13, 2025 |
| Trial ID | NCT06754605 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy adults aged 18 and older, with Phase II focusing on those aged 50 and above.
✕Probably not a fit
Patients with acute illnesses or unstable underlying diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and immunogenicity of a recombinant vaccine for Respiratory Syncytial Virus (RSV) in adults aged 18 and older. Participants will receive one of three dose levels of the vaccine or a placebo, and their health will be monitored for adverse events and immune responses over the course of a year. Key measurements include neutralizing antibodies and T cell responses at various intervals post-vaccination.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce the incidence and severity of Respiratory Syncytial Virus infections in adults.
How similar studies have gone: Other studies have shown promise in developing vaccines for RSV, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects 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 the screening period were negative. Exclusion Criteria: * 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 to vaccination. * 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 infected with RSV within 1 year prior to receiving the investigational vaccine. * 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, asplenia or functional asplenia. * 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 syndrome, and systemic sclerosis. * 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, local allergic necrosis reaction, angioneurotic edema, etc. * 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 (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in subjects \< 60 years of age; Hypertensive disease with systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg in subjects ≥60 years of age, diabetes mellitus with serious complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart diseases, respiratory diseases, liver and kidney diseases, and thyroid diseases. * 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 or sperm during the study. * 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 determined by the investigator to be unsuitable for clinical study.
Where it's running
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Hebei Zhongshiyou Central Hospital
Langfang, Hebei, China Recruiting -
Luzhou Center for Disease Control and Prevention
Luzhou, Sichuan, China Not yet recruiting
Study contacts
- Principal investigator: Zhao Kexin, Doctor — Hebei Zhongshiyou Central Hospital
- Study coordinator: Yang Xinjie, Doctor
- Email: xinjie_yang@sinocelltech.com
- Phone: 86+010-58628288
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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RSV+HMPV protein shot for adults 60 and older
A single shot of a two-virus vaccine is being tested in adults 60+ to see if it can prevent RSV and hMPV infections compared with placebo.
-
Real-world safety monitoring of Beyfortus (nirsevimab) in Korean infants and toddlers
This program follows children up to 24 months in Korea who receive Beyfortus to see if the medicine is safe when used in routine care.
-
Antiviral treatment for early RSV symptoms
This trial will test whether antiviral drugs—ribavirin, molnupiravir, or favipiravir—can lower viral levels and help adults 18–64 with early RSV recover faster than receiving no antiviral treatment.
-
Examining the impact of COVID-19 on RSV-related emergency visits in children
This study looks at how COVID-19 affected emergency visits for bronchiolitis and RSV in young children to see what might happen as restrictions ease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.