Evaluating a new vaccine for Respiratory Syncytial Virus

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

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
• Enrollment: 480 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: Sinocelltech Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 2 sites (Langfang, Hebei and 1 other locations)
• Trial ID: NCT06754605 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 and older, with Phase II focusing on those aged 50 and above.

Not a fit: Patients with acute illnesses or unstable underlying diseases may not benefit from this study.

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 performed: Other studies have shown promise in developing vaccines for RSV, but this specific approach is novel.

Eligibility 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 this trial is running

Langfang, Hebei and 1 other locations

• 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

Conditions Respiratory Syncytial Virus