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New treatment option for Respiratory Syncytial Virus Infections
Official title Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
ClinicalTrials.gov ID: NCT07582796
What this study is testing
What is Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted)?
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for respiratory syncytial virus infections.
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
- The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Males or females aged 18 years and older at the time of enrollment (aged 18 years and older for the phase I part; aged 60 years and older for the...
- Voluntarily agree to participate in the trial, able to fully understand and sign the informed consent form.
- Able to attend all scheduled follow-up visits and comply with the requirements of the clinical trial protocol to complete the study.
- Female participants must meet the following criteria: In the phase I part, women of childbearing potential\ must have a negative pregnancy test prior...
- Women of childbearing potential: Defined as females who have experienced menarche and have not yet entered menopause, unless permanently sterile...
You likely can't join if
- Clinically significant laboratory abnormalities that, in the investigator's comprehensive judgment, preclude enrollment (applicable only to the phase...
- Pregnant or breastfeeding women.
- A clear diagnosis of RSV infection or a history of RSV infection-related respiratory disease within 6 months prior to vaccination.
- Use of immunoglobulins or/and any blood products or plasma derivatives within 3 months prior to vaccination, or planned use during the study.
- Treatment with immunomodulators (including immunosuppressants and immunostimulants) within 6 months prior to vaccination (e.g., long-term use of...
- Administration or planned use of long-acting immunomodulatory drugs (e.g., infliximab) at any time during the study.
See the full eligibility criteria
- Males or females aged 18 years and older at the time of enrollment (aged 18 years and older for the phase I part; aged 60 years and older for the phase II part), who are able to provide legal proof of identity.
- Voluntarily agree to participate in the trial, able to fully understand and sign the informed consent form.
- Able to attend all scheduled follow-up visits and comply with the requirements of the clinical trial protocol to complete the study.
- Female participants must meet the following criteria: In the phase I part, women of childbearing potential\ must have a negative pregnancy test prior to enrollment and be willing to use effective contraceptive measures...
- Women of childbearing potential: Defined as females who have experienced menarche and have not yet entered menopause, unless permanently sterile, such as documented bilateral salpingectomy, bilateral oophorectomy, or...
- Axillary body temperature ≤ 37.0°C measured on site prior to vaccination on the day of vaccination.
- Clinically significant laboratory abnormalities that, in the investigator's comprehensive judgment, preclude enrollment (applicable only to the phase I part).
- Pregnant or breastfeeding women.
- A clear diagnosis of RSV infection or a history of RSV infection-related respiratory disease within 6 months prior to vaccination.
- Use of immunoglobulins or/and any blood products or plasma derivatives within 3 months prior to vaccination, or planned use during the study.
- Treatment with immunomodulators (including immunosuppressants and immunostimulants) within 6 months prior to vaccination (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20...
- Administration or planned use of long-acting immunomodulatory drugs (e.g., infliximab) at any time during the study.
- A history of severe allergic reactions (e.g., anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, Arthus reaction) following any previous vaccination or drug use, or a...
- Impaired immune function or a diagnosis of congenital or acquired immunodeficiency, or human immunodeficiency virus (HIV) infection.
- A personal or family history of convulsions, epilepsy, encephalopathy, psychiatric disorders, or neurological diseases (such as Guillain-Barré syndrome, Miller Fisher syndrome).
- A diagnosis of lymphoproliferative disease or malignant tumor within 5 years.
- Clinically significant electrocardiogram (ECG) abnormalities as determined by the investigator (applicable only to the phase I part).
- Previous vaccination with any licensed or investigational RSV vaccine prior to enrollment, or planned vaccination during the study.
- Receipt of any vaccine within 14 days prior to vaccination, or any live vaccine within 30 days prior to vaccination.
- An acute disease or an acute exacerbation of a chronic disease within 3 days prior to vaccination, or use of antipyretic, analgesic, or anti-allergy medications.
- Suspected or known alcohol abuse or alcohol dependence (referring to a drinking pattern that causes serious mental or physical health problems) or drug abuse.
- A history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection.
- Severe or unstable chronic diseases, including but not limited to cardiovascular diseases [e.g., hypertension uncontrolled by medication (on-site blood pressure measurement prior to vaccination: systolic blood pressure...
- A history of confirmed immune-mediated/autoimmune diseases (e.g., cold agglutinin hemolytic anemia, lymphadenopathy, eosinophilia, systemic lupus erythematosus, gout, hyperuricemia, acute disseminated encephalomyelitis...
- Asplenia or functional asplenia, as well as any condition resulting in asplenia or splenectomy.
- Currently participating in or planning to participate in another clinical study involving investigational or unregistered products (drugs, vaccines, medical devices, etc.) during this study.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Zigong, 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zigong, 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.