A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine

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

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine (NCT06754605) is a Phase 1 / Phase 2 interventional studying Respiratory Syncytial Virus, sponsored by Sinocelltech Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Respiratory Syncytial Virus, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 480 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BIOLOGICAL

SCTV02

Participants will receive a singe dose of SCTV02 on Day 0.

BIOLOGICAL

Placebo

Participants will receive a singe dose of Placebo on Day 0.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hebei Zhongshiyou Central Hospital

Langfang, Hebei, China

Luzhou Center for Disease Control and Prevention

Luzhou, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06754605), the sponsor (Sinocelltech Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06754605 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06754605?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06754605?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06754605. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06754605. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.